Group B Streptococcus InfectionsPhase 2NCT03765073
Trial To Evaluate The Safety, Tolerability, And Immunogenicity Of A Multivalent Group B Streptococcus Vaccine In Healthy Nonpregnant Women And Pregnant Women And Their Infants
A Phase 2 study testing Multivalent Group B streptococcus vaccine in people with Group B Streptococcus Infections, run by Pfizer at 35 sites in 3 countries.
Trial summary
Phase 1/2, randomized, placebo-controlled, observer-blinded study will evaluate the safety, tolerability and immunogenicity of the investigational multivalent group B streptococcus vaccine administered at one dose level (various formulations) in healthy nonpregnant women (various formulations at one dose level), and… Read more about this study
- Who is it for?
- Ages 0 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Group B Streptococcus Infections
- What is being tested?
- Multivalent Group B streptococcus vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,208 participants
- Where
- 35 sitesin 3 countries
- Study dates
- 14 Jan 2019to 4 Mar 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Healthy nonpregnant females 18 to 40 years of age at enrollment who are determined by medical history, physical examination, and clinical judgment of the investigator to be eligible for inclusion in the study.
- Negative urine pregnancy test at Visit 1 (prior to vaccination).
- Documented negative HIV, hepatitis C virus (HCV), and acute or chronic hepatitis B virus (HBV) infection at screening.
- Participant must have received investigational product at Visit 1.
- Healthy nonpregnant female determined by medical history, physical examination, and clinical judgment of the investigator to be eligible for booster vaccination and received investigational product at Visit 1.
- Negative urine pregnancy test at Visit 6 (prior to vaccination).
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- Documented negative HIV, hepatitis C virus (HCV), and acute or chronic hepatitis B virus (HBV) infection at screening.
- Healthy females >=18 and <=40 years of age who are >=27 0/7 (Stage 2) or >=24 0/7 (Stage 3) to <=35 6/7 weeks' gestation on the day of planned vaccination, with an uncomplicated, singleton pregnancy, and at no increased risk for complications and no significant fetal abnormalities observed on ultrasound performed at any time prior to study entry and/or at the screening visit.
- Documented negative HIV antibody, HBV surface antigen, HCV antibody, and syphilis tests at screening.
- Evidence of a signed and dated ICD signed by the parent(s). Parent(s) willing and able to comply with scheduled visits, investigational plan, laboratory tests, and other study procedures.
Who cannot join
- Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
- History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the investigational product or any diphtheria toxoid-containing or CRM197 containing vaccine.
- History of microbiologically proven invasive disease caused by GBS (S agalactiae).
- Previous vaccination with any licensed or investigational GBS vaccine (other than GBS6 received as a primary vaccination at Visit 1), or planned receipt during the participant's participation in the study (through the last blood draw).
- Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
- History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the investigational product or any diphtheria toxoid-containing or CRM197 containing vaccine.
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- History of microbiologically proven invasive disease caused by GBS (S agalactiae).
- Previous vaccination with any licensed or investigational group B streptococcus vaccine, or planned receipt during the participant's participation in the study (through the last blood draw).
- Prepregnancy body mass index (BMI) of ≥40 kg/m2. If prepregnancy BMI is not available, the BMI at the time of the first obstetric visit during the current pregnancy may be used.
- A prior history of or current pregnancy complications or abnormalities that will increase the risk associated with the participant's participation.
- Major illness of the mother or conditions of the fetus that, in the investigator's judgment, will substantially increase the risk associated with the participant's participation in, and completion of, the study or could preclude the evaluation of the participant's response.
- Infant who is a direct descendant (eg, child or grandchild) of the study personnel.
Trial locations and contacts
35 sites in 3 countries.
35 sites in 3 countries
United States26 sites
Lakeview Regional Medical Center
Covington, Louisiana, 70433
MedPharmics
Covington, Louisiana, 70433
St. Tammany Parish Hospital
Covington, Louisiana, 70433
North Oaks Medical Center
Hammond, Louisiana, 70403
North Oaks Obstetrics & Gynecology
Hammond, Louisiana, 70403
Meridian Clinical Research
Hastings, Nebraska, 68901
Clinical Research Prime
Idaho Falls, Idaho, 83404
Chemidox Clinical Trials Inc.
Lancaster, California, 93534
Chemidox Clinical Trials Inc
Lancaster, California, 93534
Frontier Pediatric Care (Follow-Up Visits for Infant Participants)
Lincoln, Nebraska, 68506
Bryan Women's Care Physicians (Maternal Visits & Obstetric Exams)
Lincoln, Nebraska, 68510
Be Well Clinical Studies
Lincoln, Nebraska, 68516
Boeson Research
Missoula, Montana, 59804
Community Hospital
Missoula, Montana, 59804
The Birth Center
Missoula, Montana, 59804
Velocity Clinical Research
Mobile, Alabama, 36608
Sentara Leigh Hospital
Norfolk, Virginia, 23502
The Group for Women
Norfolk, Virginia, 23502
Tidewater Physicians for Women
Norfolk, Virginia, 23502
Velocity Clinical Research, Phoenix
Phoenix, Arizona, 85006
Clinical Research Prime Rexburg
Rexburg, Idaho, 83440
Velocity Clinical Research
Slidell, Louisiana, 70458
Lowcountry Women's Specialists
Summerville, South Carolina, 29485
Summerville Medical Center
Summerville, South Carolina, 29485
Coastal Pediatric Research
Summerville, South Carolina, 29486
Emerson Clinical Research Institute
Washington D.C., District of Columbia, 20009
South Africa8 sites
Empilweni Services and Research Unit (ESRU)
Coronationville, Johannesburg, 2093
Wits Reproductive Health and HIV Institute
Johannesburg, Gauteng, 2001
Khayelitsha District Hospital (KDH)
Khayelitsha, Western Cape, 7784
Michael Mapongwana Community Health Centre
Khayelitsha, Western Cape, 7784
Site B
Khayelitsha, Western Cape, 7784
Charlotte Maxeke Johannesburg Academic Hospital
Parktown, Johannesburg, Gauteng, 2196
FAMCRU
Parow Valley, Western Cape, 7505
Respiratory and Meningeal Pathogens Research Unit (RMPRU)
Soweto, Gauteng, 1862
United Kingdom1 site
St George's University Hospitals NHS Foundation Trust
London, Tooting, SW17 0QT
About this study
Official title: A PHASE 1/2, RANDOMIZED, PLACEBO-CONTROLLED, OBSERVER-BLINDED TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A MULTIVALENT GROUP B STREPTOCOCCUS VACCINE IN HEALTHY NONPREGNANT WOMEN AND PREGNANT WOMEN 18 TO 40 YEARS OF AGE AND THEIR INFANTS
Phase 1/2, randomized, placebo-controlled, observer-blinded study will evaluate the safety, tolerability and immunogenicity of the investigational multivalent group B streptococcus vaccine administered at one dose level (various formulations) in healthy nonpregnant women (various formulations at one dose level), and then in healthy pregnant women (various formulations at three dose levels), and finally in healthy pregnant women at a selected dose level/formulation.
- Conditions
- Group B Streptococcus Infections
- Being tested
- Multivalent Group B streptococcus vaccine, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multivalent Group B streptococcus vaccineBiological
Various formulations at three dose levels
PlaceboBiological
Saline control
| Study group | Role | What they receive |
|---|---|---|
| Stage 1 - Highest dose formulation a | Experimental | Multivalent group B streptococcus vaccine - Stage 1 Nonpregnant women Receives: Biological: Multivalent Group B streptococcus vaccine |
| Stage 1 - Highest dose formulation b | Experimental | Multivalent group B streptococcus vaccine - Stage 1 Nonpregnant women Receives: Biological: Multivalent Group B streptococcus vaccine |
| Stage 2 - Lowest dose formulation a | Experimental | Multivalent group B streptococcus vaccine - Stage 2 Pregnant women Receives: Biological: Multivalent Group B streptococcus vaccine |
| Stage 2 - Lowest dose formulation b | Experimental | Multivalent group B streptococcus vaccine - Stage 2 Pregnant women Receives: Biological: Multivalent Group B streptococcus vaccine |
| Stage 2 - Middle dose formulation a | Experimental | Multivalent group B streptococcus vaccine - Stage 2 Pregnant women Receives: Biological: Multivalent Group B streptococcus vaccine |
| Stage 2 - Middle dose formulation b | Experimental | Multivalent group B streptococcus vaccine - Stage 2 Pregnant women Receives: Biological: Multivalent Group B streptococcus vaccine |
| Stage 2 - Highest dose formulation a | Experimental | Multivalent group B streptococcus vaccine - Stage 2 Pregnant women Receives: Biological: Multivalent Group B streptococcus vaccine |
| Stage 2 - Highest dose formulation b | Experimental | Multivalent group B streptococcus vaccine - Stage 2 Pregnant women Receives: Biological: Multivalent Group B streptococcus vaccine |
| Stage 3 - Selected dose and formulation | Experimental | Multivalent group B streptococcus vaccine - Stage 3 Pregnant women Receives: Biological: Multivalent Group B streptococcus vaccine |
| Stage 1 Placebo | Placebo comparator | Saline control Receives: Biological: Placebo |
| Stage 2 Placebo | Placebo comparator | Saline control Receives: Biological: Placebo |
| Stage 3 Placebo | Placebo comparator | Saline control Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Reporting Local Reactions Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1
Local reactions (redness, swelling, and pain at the injection site of the left arm) were recorded by participants in e-diary. Erythema/Redness and induration/swelling were measured and recorded in measuring device units (1 measuring device unit=0.5 centimeter [cm]). Grading: Grade 1/mild (greater than [>] 2.5 to 5.0 cm), Grade 2/moderate (>5.0 to 10.0 cm), Grade 3/severe (>10.0 cm) and Grade 4 (necrosis [swelling] or necrosis or exfoliative dermatitis [redness]). Pain at injection site was graded as Grade 1/mild (did not interfere with activity), Grade2/moderate (interfered with activity), Grade 3/severe (prevented daily activity) and Grade 4 (emergency room [ER] visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person.
Measured: Day 1 (day of vaccination) to Day 7 after Primary Dose
Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Dose: Non-Pregnant Women Stage 1
Local reactions (redness, swelling, and pain at the injection site of the left arm) were recorded by participants in e-diary. Erythema/Redness and induration/swelling were measured and recorded in measuring device units (1 measuring device unit=0.5 centimeter [cm]). Grading: Grade 1/mild (greater than [>] 2.5 to 5.0 cm), Grade 2/moderate (>5.0 to 10.0 cm), Grade 3/severe (>10.0 cm) and Grade 4 (necrosis [swelling] or necrosis or exfoliative dermatitis [redness]). Pain at injection site was graded as Grade 1/mild (did not interfere with activity), Grade2/moderate (interfered with activity), Grade 3/severe (prevented daily activity) and Grade 4 (emergency room [ER] visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person.
Measured: Day 1 (day of vaccination) to Day 7 after booster dose
Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1
Systemic events were recorded in e-diary. Fever: oral temperature greater than or equal to (>=) 38.0 degree Celsius (deg C) and categorized as >=38.0-38.4 deg C, >38.4-38.9 deg C, >38.9-40.0 deg C and >40.0 deg C. Nausea/vomiting was graded as: Grade 1/mild (1-2 times in 24 hours [h]), Grade 2/moderate: (>2 times in 24h), Grade 3/severe (required intravenous hydration) and Grade 4 (ER visit/hospitalization for hypotensive shock). Diarrhea was graded as: Grade 1/mild (2-3 loose stools in 24h), Grade 2/moderate (4-5 loose stools in 24h), Grade 3/severe (6 or more loose stools in 24h) and Grade 4 (ER visit/hospitalization for severe diarrhea). Fatigue/tiredness, headache, muscle pain and joint pain were graded as: Grade 1/mild (did not interfere with activity), Grade 2/moderate (some interference with activity), Grade 3/severe (prevented daily routine activity) and Grade 4 (ER visit/hospitalization). Grade 4 were classified by investigator or medically qualified person.
Measured: Day 1 (day of vaccination) to Day 7 after primary dose
Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1
Systemic events were recorded in e-diary. Fever: oral temperature greater than or equal to (>=) 38.0 degree Celsius (deg C) and categorized as >=38.0-38.4 deg C, >38.4-38.9 deg C, >38.9-40.0 deg C and >40.0 deg C. Nausea/vomiting was graded as: Grade 1/mild (1-2 times in 24 hours [h]), Grade 2/moderate: (>2 times in 24h), Grade 3/severe (required intravenous hydration) and Grade 4 (ER visit/hospitalization for hypotensive shock). Diarrhea was graded as: Grade 1/mild (2-3 loose stools in 24h), Grade 2/moderate (4-5 loose stools in 24h), Grade 3/severe (6 or more loose stools in 24h) and Grade 4 (ER visit/hospitalization for severe diarrhea). Fatigue/tiredness, headache, muscle pain and joint pain were graded as: Grade 1/mild (did not interfere with activity), Grade 2/moderate (some interference with activity), Grade 3/severe (prevented daily routine activity) and Grade 4 (ER visit/hospitalization). Grade 4 were classified by investigator or medically qualified person.
Measured: Day 1 (day of vaccination) to Day 7 after booster dose
Percentage of Participants Reporting Adverse Events (AEs) Through 1 Month After Primary Dose: Non-Pregnant Participants Stage 1
An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. Examples of AEs included but were not limited to abnormal test findings; clinically significant signs and symptoms; changes in physical examination findings; hypersensitivity; progression/worsening of underlying disease; drug abuse; drug dependency.
Measured: Day 1 (day of vaccination) through 1 Month post primary dose
Percentage of Participants Reporting AEs Through 1 Month After Booster Dose: Non-Pregnant Participants Stage 1
An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. Examples of AEs included but were not limited to abnormal test findings; clinically significant signs and symptoms; changes in physical examination findings; hypersensitivity; progression/worsening of underlying disease; drug abuse; drug dependency.
Measured: Day 1 (day of vaccination) through 1 Month post booster dose
Percentage of Participants Reporting Medically Attended Adverse Events (MAEs) Through 6 Months After Primary Dose: Non-Pregnant Participants Stage 1
An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. Examples of AEs included but were not limited to abnormal test findings; clinically significant signs and symptoms; changes in physical examination findings; hypersensitivity; progression/worsening of underlying disease; drug abuse; drug dependency. A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility.
Measured: Day 1 (day of vaccination) through 6 Months post primary dose
Percentage of Participants Reporting Serious Adverse Events (SAEs) Through 6 Months After Primary Dose: Non-Pregnant Participants Stage 1
An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. Examples of AEs included but were not limited to abnormal test findings; clinically significant signs and symptoms; changes in physical examination findings; hypersensitivity; progression/worsening of underlying disease; drug abuse; drug dependency. A SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); congenital anomaly/birth defect; or that was considered as an important medical event.
Measured: Day 1 (day of vaccination) through 6 Months post primary dose
Percentage of Participants Reporting MAEs Approximately 7 to 12 Months After Booster Dose: Non-Pregnant Participants Stage 1
An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. Examples of AEs included but were not limited to abnormal test findings; clinically significant signs and symptoms; changes in physical examination findings; hypersensitivity; progression/worsening of underlying disease; drug abuse; drug dependency. A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility.
Measured: Day 1 (day of vaccination) through approximately 7 to 12 months post booster dose
Percentage of Participants Reporting SAEs Approximately 7 to 12 Months After Booster Dose: Non-Pregnant Participants Stage 1
An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. Examples of AEs included but were not limited to abnormal test findings; clinically significant signs and symptoms; changes in physical examination findings; hypersensitivity; progression/worsening of underlying disease; drug abuse; drug dependency. A SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); congenital anomaly/birth defect; or that was considered as an important medical event.
Measured: Day 1 (day of vaccination) through approximately 7 to 12 months post booster dose
Number of Participants With Clinical Laboratory Abnormalities at 2 Week Follow-up Visit: Maternal Participants Stage 2
Hemoglobin: Grade 1, Platelets High: Grade 2, White blood cells decreased: Grade 1, Neutrophils (Absolute): Grade 1, Basophils (Absolute): Grade 2, Lymphocytes Low (Absolute): Grade1, Blood urea nitrogen (bun): Grade 1, Aspartate aminotransferase (AST): Grade 2, Alanine aminotransferase (ALT): Grade 1 and 3 and Alkaline phosphate: Grade 1. Grades were considered as 1: mild, 2: moderate, 3: severe. Only categories with non-zero values were reported for this outcome measure.
Measured: 2 weeks after vaccination in Stage 2
Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2
Local reactions (redness, swelling, and pain at the injection site of the left arm) were recorded by participants in e-diary. Erythema/Redness and induration/swelling were measured and recorded in measuring device units (1 measuring device unit=0.5 cm). Grading: Grade 1/mild (> 2.5 to 5.0 cm), Grade 2/moderate (>5.0 to 10.0 cm), Grade 3/severe (>10.0 cm) and Grade 4 (necrosis [swelling] or necrosis or exfoliative dermatitis [redness]). Pain at injection site was graded as Grade 1/mild (did not interfere with activity), Grade2/moderate (interfered with activity), Grade 3/severe (prevented daily activity) and Grade 4 (ER visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person.
Measured: Day 1 (day of vaccination) to Day 7 after Vaccination
Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 3
Local reactions (redness, swelling, and pain at the injection site of the left arm) were recorded by participants in e-diary. Erythema/Redness and induration/swelling were measured and recorded in measuring device units (1 measuring device unit=0.5 cm). Grading: Grade 1/mild (> 2.5 to 5.0 cm), Grade 2/moderate (>5.0 to 10.0 cm), Grade 3/severe (>10.0 cm) and Grade 4 (necrosis [swelling] or necrosis or exfoliative dermatitis [redness]). Pain at injection site was graded as Grade 1/mild (did not interfere with activity), Grade2/moderate (interfered with activity), Grade 3/severe (prevented daily activity) and Grade 4 (ER visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person.
Measured: Day 1 (day of vaccination) to Day 7 after Vaccination
Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2
Systemic events were recorded in e-diary. Fever: oral temperature >=38.0 deg C and categorized as >=38.0-38.4 deg C, >38.4-38.9 deg C, >38.9-40.0 deg C and >40.0 deg C. Nausea/vomiting was graded as: Grade 1/mild (1-2 times in 24 h), Grade 2/moderate: (>2 times in 24h), Grade 3/severe (required intravenous hydration) and Grade 4 (ER visit/hospitalization for hypotensive shock). Diarrhea was graded as: Grade 1/mild (2-3 loose stools in 24h), Grade 2/moderate (4-5 loose stools in 24h), Grade 3/severe (6 or more loose stools in 24h) and Grade 4 (ER visit/hospitalization for severe diarrhea). Fatigue/tiredness, headache, muscle pain and joint pain were graded as: Grade 1/mild (did not interfere with activity), Grade 2/moderate (some interference with activity), Grade 3/severe (prevented daily routine activity) and Grade 4 (ER visit/hospitalization). Grade 4 were classified by investigator or medically qualified person.
Measured: Day 1 (day of vaccination) to Day 7 after Vaccination
Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 3
Systemic events were recorded in e-diary. Fever: oral temperature >=38.0 deg C and categorized as >=38.0-38.4 deg C, >38.4-38.9 deg C, >38.9-40.0 deg C and >40.0 deg C. Nausea/vomiting was graded as: Grade 1/mild (1-2 times in 24 h), Grade 2/moderate: (>2 times in 24h), Grade 3/severe (required intravenous hydration) and Grade 4 (ER visit/hospitalization for hypotensive shock). Diarrhea was graded as: Grade 1/mild (2-3 loose stools in 24h), Grade 2/moderate (4-5 loose stools in 24h), Grade 3/severe (6 or more loose stools in 24h) and Grade 4 (ER visit/hospitalization for severe diarrhea). Fatigue/tiredness, headache, muscle pain and joint pain were graded as: Grade 1/mild (did not interfere with activity), Grade 2/moderate (some interference with activity), Grade 3/severe (prevented daily routine activity) and Grade 4 (ER visit/hospitalization). Grade 4 were classified by investigator or medically qualified person.
Measured: Day 1 (day of vaccination) to Day 7 after Vaccination
Percentage of Participants Reporting AEs Through 1 Month After Administration of Investigational Product: Maternal Participants Stage 2
An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. Examples of AEs included but were not limited to abnormal test findings; clinically significant signs and symptoms; changes in physical examination findings; hypersensitivity; progression/worsening of underlying disease; drug abuse; drug dependency.
Measured: Day 1 (day of vaccination) through 1 Month post vaccination
Percentage of Participants Reporting AEs Through 1 Month After Administration of Investigational Product: Maternal Participants Stage 3
An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. Examples of AEs included but were not limited to abnormal test findings; clinically significant signs and symptoms; changes in physical examination findings; hypersensitivity; progression/worsening of underlying disease; drug abuse; drug dependency.
Measured: Day 1 (day of vaccination) through 1 Month post vaccination
Percentage of Participants With SAEs From Day 1 Through 12 Months Post-delivery: Maternal Participants Stage 2
An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. Examples of AEs included but were not limited to abnormal test findings; clinically significant signs and symptoms; changes in physical examination findings; hypersensitivity; progression/worsening of underlying disease; drug abuse; drug dependency. A SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); congenital anomaly/birth defect; or that was considered as an important medical event.
Measured: Day 1 (day of vaccination) through 12 Month post delivery
Percentage of Participants With SAEs From Day 1 Through 12 Months Post-delivery: Maternal Participants Stage 3
An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. Examples of AEs included but were not limited to abnormal test findings; clinically significant signs and symptoms; changes in physical examination findings; hypersensitivity; progression/worsening of underlying disease; drug abuse; drug dependency. A SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); congenital anomaly/birth defect; or that was considered as an important medical event.
Measured: Day 1 (day of vaccination) through 12 Month post delivery
Percentage of Participants With MAEs From Day 1 Through 12 Months Post-delivery: Maternal Participants Stage 2
An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. Examples of AEs included but were not limited to abnormal test findings; clinically significant signs and symptoms; changes in physical examination findings; hypersensitivity; progression/worsening of underlying disease; drug abuse; drug dependency. A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility.
Measured: Day 1 (day of vaccination) through 12 Month post delivery
Percentage of Participants With MAEs From Day 1 Through 12 Months Post-delivery: Maternal Participants Stage 3
An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. Examples of AEs included but were not limited to abnormal test findings; clinically significant signs and symptoms; changes in physical examination findings; hypersensitivity; progression/worsening of underlying disease; drug abuse; drug dependency. A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility.
Measured: Day 1 (day of vaccination) through 12 Month post delivery
Percentage of Participants With Obstetric Complications From Visit 1 Through 12 Months Post-delivery: Maternal Participants Stage 2
Obstetric complications such as: prepartum period, intrapartum period and postpartum period were reported in this outcome measure.
Measured: Day 1 (day of vaccination) through 12 Month post delivery
Percentage of Participants With Obstetric Complications From Day 1 Through 12 Months Post-delivery: Maternal Participants Stage 3
Obstetric complications such as: prepartum period, intrapartum period and postpartum period were reported in this outcome measure.
Measured: Day 1 (day of vaccination) through 12 Month post delivery
Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 2
Delivery Outcome included full term live delivery, premature live delivery, Stillbirth, induced/elective abortion and unknown. Mode of delivery included: vaginal delivery, Cesarean section: elective, semi-elective and emergency were reported in this outcome measure.
Measured: At delivery
Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 3
Delivery Outcome included full term live delivery, premature live delivery, Stillbirth, induced/elective abortion and unknown. Mode of delivery included: vaginal delivery, Cesarean section: elective, semi-elective and emergency were reported in this outcome measure.
Measured: At delivery
Percentage of Participants With Gestational Age at Birth: Infant Participants Stage 2
Gestational age of participants at birth in weeks included: greater than or equal to (>=)24 weeks to less than (<) 28 weeks, >=28 weeks to <34 weeks, >=34 weeks to <37 weeks, >=37 weeks to <42 weeks, >=42 weeks.
Measured: At Birth
Appearance, Pulse, Grimace, Activity, and Respiration (APGAR) Score at 1 Minute: Infant Participants Stage 2
APGAR is a scoring system that evaluates Activity, Pulse, Grimace, Appearance, and Respiration. Each category is given a score of 0-2 points (with 0 being absent and 2 being normal), the points are then combined for a total score that ranges from 0-10. Scores 7 and above are generally normal, 4 to 6 are fairly low, and 2 and below are considered critically low. APGAR score at 1 minute were reported in this outcome measure.
Measured: At 1 minute of Birth
Appearance, Pulse, Grimace, Activity, and Respiration (APGAR) Score at 5 Minutes: Infant Participants Stage 2
APGAR is a scoring system that evaluates Activity, Pulse, Grimace, Appearance, and Respiration. Each category is given a score of 0-2 points (with 0 being absent and 2 being normal), the points are then combined for a total score that ranges from 0-10. Scores 7 and above are generally normal, 4 to 6 are fairly low, and 2 and below are considered critically low. APGAR score at 5 minute were reported in this outcome measure.
Measured: At 5 minutes of Birth
Number of Participants According to Age Determined by Ballard Score: Infant Participants Stage 2
The Ballard score is a commonly used technique of gestational age assessment. It assists healthcare providers in determining if an infant is premature, on time, or post-term based on physical traits. This scoring allows for the estimation of age in the range of 26 weeks to 44 weeks Participants according to age determined by Ballard score: at <37 weeks 0 days, >=37 weeks to <42 weeks, >=42 weeks were reported in this outcome measure. Ballard score was not conducted routinely/mandatory.
Measured: At Birth
Number of Participants With Newborn Assessment at Birth: Infant Participants Stage 2
Participants with newborn assessment at birth included: normal, congenital malformation/anomaly, other neonatal problem were reported in this outcome measure.
Measured: At Birth
Number of Participants With Vital Status: Infant Participants Stage 2
Participants according to vital status as: live or neonatal death were reported in this outcome measure.
Measured: At Birth
Number of Participants With Gestational Age of Participants at Birth: Infant Participants Stage 3
Gestational age of participants at birth in weeks included: greater than or equal to (>=)24 weeks to less than (<) 28 weeks, >=28 weeks to <34 weeks, >=34 weeks to <37 weeks, >=37 weeks to <42 weeks, >=42 weeks.
Measured: At 1 minute of Birth
Appearance, Pulse, Grimace, Activity, and Respiration (APGAR) Score at 1 Minute: Infant Participants Stage 3
APGAR is a scoring system that evaluates Activity, Pulse, Grimace, Appearance, and Respiration. Each category is given a score of 0-2 points (with 0 being absent and 2 being normal), the points are then combined for a total score that ranges from 0-10. Scores 7 and above are generally normal, 4 to 6 are fairly low, and 2 and below are considered critically low. Appearance, pulse, grimace, activity, and respiration (APGAR) score at 1 minute were reported in this outcome measure.
Measured: At 1 minute of Birth
APGAR Score at 5 Minutes: Infant Participants Stage 3
APGAR is a scoring system that evaluates Activity, Pulse, Grimace, Appearance, and Respiration. Each category is given a score of 0-2 points (with 0 being absent and 2 being normal), the points are then combined for a total score that ranges from 0-10. Scores 7 and above are generally normal, 4 to 6 are fairly low, and 2 and below are considered critically low. Appearance, pulse, grimace, activity, and respiration (APGAR) score at 5 minute were reported in this outcome measure.
Measured: At 5 minutes of Birth
Number of Participants According to Age Determined by Ballard Score: Infant Participants Stage 3
The Ballard score is a commonly used technique of gestational age assessment. It assists healthcare providers in determining if an infant is premature, on time, or post-term based on physical traits. This scoring allows for the estimation of age in the range of 26 weeks to 44 weeks Participants according to age determined by Ballard score: at <37 weeks 0 days, >=37 weeks to <42 weeks, >=42 weeks were reported in this outcome measure. Ballard score was not conducted routinely/mandatory.
Measured: At Birth
Number of Participants With Newborn Assessment at Birth: Infant Participants Stage 3
Participants with newborn assessment at birth included: normal, congenital malformation/anomaly, other neonatal problem were reported in this outcome measure.
Measured: At 5 minutes of Birth
Number of Participants With Vital Status: Infant Participants Stage 3
Participants according to vital status as: live or neonatal death were reported in this outcome measure.
Measured: At Birth
Number of Participants With AEs From Birth to 6 Weeks of Age: Infant Participants Stage 2
An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage.
Measured: From Birth to 6 Weeks
Numberof Participants With AEs From Birth to 6 Weeks of Age: Infant Participants Stage 3
An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage.
Measured: From Birth to 6 Weeks
Number of Participants With SAEs From Birth to 12 Months of Age: Infant Participants Stage 2
An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. A SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); congenital anomaly/birth defect; or that was considered as an important medical event.
Measured: From Birth to 12 Months
Number of Participants With SAEs From Birth to 12 Months of Age: Infant Participants Stage 3
An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. A SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); congenital anomaly/birth defect; or that was considered as an important medical event.
Measured: From Birth to 12 Months
Number of Participants With MAEs From Birth to 12 Months of Age: Infant Participants Stage 2
An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility.
Measured: From Birth to 12 Months
Number of Participants With MAEs From Birth to 12 Months of Age: Infant Participants Stage 3
An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility.
Measured: From Birth to 12 Months
Percentage of Participants With Adverse Events of Special Interest From Birth to 12 Months of Age: Infant Participants Stage 2
An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. AEs of special interest included: major congenital anomalies, developmental delay and suspected or confirmed GBS infection.
Measured: From Birth to 12 Months
Percentage of Participants With Adverse Events of Special Interest From Birth to 12 Months of Age: Infant Participants Stage 3
An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. AEs of special interest included: major congenital anomalies, developmental delay and suspected or confirmed GBS infection.
Measured: From Birth to 12 Months
Secondary outcomes (10)
Geometric Mean Concentration (GMCs) of Group B Streptococcus (GBS) Serotype-Specific Immunoglobulin G (IgG) at 1 Month After Primary Dose: Non-Pregnant Women Stage 1
Serotypes used for evaluation were: Ia, Ib, II, III, IV, and V.
Measured: At 1 Month After primary Dose
GMCs of GBS Serotype-specific IgG Before and 1 Month, 3 Months, and 6 Months After a Booster Dose: Non Pregnant Women Stage 1
Serotypes used for evaluation were: Ia, Ib, II, III, IV, and V.
Measured: Before (immediately before booster vaccination) and at 1, 3 and 6 Months After vaccination as Booster Dose
GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2
Serotypes used for evaluation were: Ia, Ib, II, III, IV, and V.
Measured: At 2 Weeks after Vaccination, 1 Month After Vaccination and at Delivery
GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 3
Serotypes used for evaluation were: Ia, Ib, II, III, IV, and V.
Measured: At 2 Weeks after Vaccination, 1 Month After Vaccination and at Delivery
GBS6 Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2
OPA for the 6 serotypes (Ia, Ib, II, III, IV, V) were determined in all participants for each blood sample.
Measured: At 1 Month After Vaccination and at Delivery
GBS6 Serotype-Specific OPA Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 3
OPA for the 6 serotypes (Ia, Ib, II, III, IV, V) were determined in all participants for each blood sample.
Measured: At 1 Month After Vaccination and at Delivery
GMCs of GBS6 Serotype-Specific IgG Infant Participant at Birth: Infant Participants Stage 2
Serotypes used for evaluation were: Ia, Ib, II, III, IV, and V.
Measured: At Birth
GMCs of GBS6 Serotype-Specific IgG Infant Participant at Birth: Infant Participants Stage 3
Serotypes used for evaluation were: Ia, Ib, II, III, IV, and V.
Measured: At Birth
GBS6 Serotype-Specific OPA GMTs Measured at Birth: Infant Participants Stage 2
Serotypes used for evaluation were: Ia, Ib, II, III, IV, and V.
Measured: At Birth
GBS6 Serotype-Specific OPA GMTs Measured at Birth: Infant Participants Stage 3
Serotypes used for evaluation were: Ia, Ib, II, III, IV, and V.
Measured: At Birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2018
- Study start14 Jan 2019
- Primary completion4 Mar 2024
- Study completion4 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Group B Streptococcus InfectionsStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,208 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03765073
- Sponsor's protocol ID
- C1091002
- Other IDs
- 2020-005074-96
- Status last verified
- Jun 2025
- First submitted
- 4 Dec 2018
- Last updated
- 5 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Publications
Madhi SA, Snaggs H, Skogeby Z, Feng Y, Barnabas S, Baker J, Fairlie L, Beeslaar J, Radley D, Jiang HQ, Silmon de Monerri NC, Simon R, McLaughlin L, Gaylord M, Skinner J, Munjal I, Anderson AS, Gurtman A. Maternal 6-valent group B Streptococcus vaccine in non-pregnant and pregnant females: a randomized phase 1/2 trial. Nat Med. 2026 Aug;32(8):3048-3059. doi: 10.1038/s41591-026-04558-5. Epub 2026 Jul 28.
PubMed 42521820Cutland CL, Sawry S, Fairlie L, Barnabas S, Frajzyngier V, Roux JL, Izu A, Kekane-Mochwari KE, Vika C, De Jager J, Munson S, Jongihlati B, Stark JH, Absalon J. Obstetric and neonatal outcomes in South Africa. Vaccine. 2024 Feb 27;42(6):1352-1362. doi: 10.1016/j.vaccine.2024.01.054. Epub 2024 Feb 3.
PubMed 38310014Madhi SA, Anderson AS, Absalon J, Radley D, Simon R, Jongihlati B, Strehlau R, van Niekerk AM, Izu A, Naidoo N, Kwatra G, Ramsamy Y, Said M, Jones S, Jose L, Fairlie L, Barnabas SL, Newton R, Munson S, Jefferies Z, Pavliakova D, Silmon de Monerri NC, Gomme E, Perez JL, Scott DA, Gruber WC, Jansen KU. Potential for Maternally Administered Vaccine for Infant Group B Streptococcus. N Engl J Med. 2023 Jul 20;389(3):215-227. doi: 10.1056/NEJMoa2116045.
PubMed 37467497
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE 1/2, RANDOMIZED, PLACEBO-CONTROLLED, OBSERVER-BLINDED TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A MULTIVALENT GROUP B STREPTOCOCCUS VACCINE IN HEALTHY NONPREGNANT WOMEN AND PREGNANT WOMEN 18 TO 40 YEARS OF AGE AND THEIR INFANTS
- ClinicalTrials.gov ID
- NCT03765073
- Acronym / sponsor ID
- C1091002
- Conditions
- Group B Streptococcus Infections
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,208 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 14 Jan 2019 (actual)
- Primary completion
- 4 Mar 2024 (actual)
- Study completion
- 4 Mar 2024 (actual)
- First posted
- 5 Dec 2018 (actual)
- Results
- Posted 5 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase 1/2, randomized, placebo-controlled, observer-blinded study will evaluate the safety, tolerability and immunogenicity of the investigational multivalent group B streptococcus vaccine administered at one dose level (various formulations) in healthy nonpregnant women (various formulations at one dose level), and then in healthy pregnant women (various formulations at three dose levels), and finally in healthy pregnant women at a selected dose level/formulation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| Stage 1 - Highest dose formulation a | Experimental | Biological: Multivalent Group B streptococcus vaccineMultivalent group B streptococcus vaccine - Stage 1 Nonpregnant women |
| Stage 1 - Highest dose formulation b | Experimental | Biological: Multivalent Group B streptococcus vaccineMultivalent group B streptococcus vaccine - Stage 1 Nonpregnant women |
| Stage 2 - Lowest dose formulation a | Experimental | Biological: Multivalent Group B streptococcus vaccineMultivalent group B streptococcus vaccine - Stage 2 Pregnant women |
| Stage 2 - Lowest dose formulation b | Experimental | Biological: Multivalent Group B streptococcus vaccineMultivalent group B streptococcus vaccine - Stage 2 Pregnant women |
| Stage 2 - Middle dose formulation a | Experimental | Biological: Multivalent Group B streptococcus vaccineMultivalent group B streptococcus vaccine - Stage 2 Pregnant women |
| Stage 2 - Middle dose formulation b | Experimental | Biological: Multivalent Group B streptococcus vaccineMultivalent group B streptococcus vaccine - Stage 2 Pregnant women |
| Stage 2 - Highest dose formulation a | Experimental | Biological: Multivalent Group B streptococcus vaccineMultivalent group B streptococcus vaccine - Stage 2 Pregnant women |
| Stage 2 - Highest dose formulation b | Experimental | Biological: Multivalent Group B streptococcus vaccineMultivalent group B streptococcus vaccine - Stage 2 Pregnant women |
| Stage 3 - Selected dose and formulation | Experimental | Biological: Multivalent Group B streptococcus vaccineMultivalent group B streptococcus vaccine - Stage 3 Pregnant women |
| Stage 1 Placebo | Placebo comparator | Biological: PlaceboSaline control |
| Stage 2 Placebo | Placebo comparator | Biological: PlaceboSaline control |
| Stage 3 Placebo | Placebo comparator | Biological: PlaceboSaline control |
Who may qualify
- Ages
- 0 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- Healthy nonpregnant females 18 to 40 years of age at enrollment who are determined by medical history, physical examination, and clinical judgment of the investigator to be eligible for inclusion in the study.
- Negative urine pregnancy test at Visit 1 (prior to vaccination).
- Documented negative HIV, hepatitis C virus (HCV), and acute or chronic hepatitis B virus (HBV) infection at screening.
- Participant must have received investigational product at Visit 1.
- Healthy nonpregnant female determined by medical history, physical examination, and clinical judgment of the investigator to be eligible for booster vaccination and received investigational product at Visit 1.
Key exclusion criteria (12 listed)
- Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
- History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the investigational product or any diphtheria toxoid-containing or CRM197 containing vaccine.
- History of microbiologically proven invasive disease caused by GBS (S agalactiae).
- Previous vaccination with any licensed or investigational GBS vaccine (other than GBS6 received as a primary vaccination at Visit 1), or planned receipt during the participant's participation in the study (through the last blood draw).
- Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multivalent Group B streptococcus vaccineVarious formulations at three dose levels | Biological | Stage 1 - Highest dose formulation a, Stage 1 - Highest dose formulation b, Stage 2 - Highest dose formulation a, Stage 2 - Highest dose formulation b, Stage 2 - Lowest dose formulation a, Stage 2 - Lowest dose formulation b, Stage 2 - Middle dose formulation a, Stage 2 - Middle dose formulation b, Stage 3 - Selected dose and formulation |
| PlaceboSaline control | Biological | Stage 1 Placebo, Stage 2 Placebo, Stage 3 Placebo |
Primary outcome
Percentage of Participants Reporting Local Reactions Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1
Time frame: Day 1 (day of vaccination) to Day 7 after Primary Dose
Local reactions (redness, swelling, and pain at the injection site of the left arm) were recorded by participants in e-diary. Erythema/Redness and induration/swelling were measured and recorded in measuring device units (1 measuring device unit=0.5 centimeter [cm]). Grading: Grade 1/mild (greater than [>] 2.5 to 5.0 cm), Grade 2/moderate (>5.0 to 10.0 cm), Grade 3/severe (>10.0 cm) and Grade 4 (necrosis [swelling] or necrosis or exfoliative dermatitis [redness]). Pain at injection site was graded as Grade 1/mild (did not interfere with activity), Grade2/moderate (interfered with activity), Grade 3/severe (prevented daily activity) and Grade 4 (emergency room [ER] visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person.
Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Dose: Non-Pregnant Women Stage 1
Time frame: Day 1 (day of vaccination) to Day 7 after booster dose
Local reactions (redness, swelling, and pain at the injection site of the left arm) were recorded by participants in e-diary. Erythema/Redness and induration/swelling were measured and recorded in measuring device units (1 measuring device unit=0.5 centimeter [cm]). Grading: Grade 1/mild (greater than [>] 2.5 to 5.0 cm), Grade 2/moderate (>5.0 to 10.0 cm), Grade 3/severe (>10.0 cm) and Grade 4 (necrosis [swelling] or necrosis or exfoliative dermatitis [redness]). Pain at injection site was graded as Grade 1/mild (did not interfere with activity), Grade2/moderate (interfered with activity), Grade 3/severe (prevented daily activity) and Grade 4 (emergency room [ER] visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person.
Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1
Time frame: Day 1 (day of vaccination) to Day 7 after primary dose
Systemic events were recorded in e-diary. Fever: oral temperature greater than or equal to (>=) 38.0 degree Celsius (deg C) and categorized as >=38.0-38.4 deg C, >38.4-38.9 deg C, >38.9-40.0 deg C and >40.0 deg C. Nausea/vomiting was graded as: Grade 1/mild (1-2 times in 24 hours [h]), Grade 2/moderate: (>2 times in 24h), Grade 3/severe (required intravenous hydration) and Grade 4 (ER visit/hospitalization for hypotensive shock). Diarrhea was graded as: Grade 1/mild (2-3 loose stools in 24h), Grade 2/moderate (4-5 loose stools in 24h), Grade 3/severe (6 or more loose stools in 24h) and Grade 4 (ER visit/hospitalization for severe diarrhea). Fatigue/tiredness, headache, muscle pain and joint pain were graded as: Grade 1/mild (did not interfere with activity), Grade 2/moderate (some interference with activity), Grade 3/severe (prevented daily routine activity) and Grade 4 (ER visit/hospitalization). Grade 4 were classified by investigator or medically qualified person.
Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1
Time frame: Day 1 (day of vaccination) to Day 7 after booster dose
Systemic events were recorded in e-diary. Fever: oral temperature greater than or equal to (>=) 38.0 degree Celsius (deg C) and categorized as >=38.0-38.4 deg C, >38.4-38.9 deg C, >38.9-40.0 deg C and >40.0 deg C. Nausea/vomiting was graded as: Grade 1/mild (1-2 times in 24 hours [h]), Grade 2/moderate: (>2 times in 24h), Grade 3/severe (required intravenous hydration) and Grade 4 (ER visit/hospitalization for hypotensive shock). Diarrhea was graded as: Grade 1/mild (2-3 loose stools in 24h), Grade 2/moderate (4-5 loose stools in 24h), Grade 3/severe (6 or more loose stools in 24h) and Grade 4 (ER visit/hospitalization for severe diarrhea). Fatigue/tiredness, headache, muscle pain and joint pain were graded as: Grade 1/mild (did not interfere with activity), Grade 2/moderate (some interference with activity), Grade 3/severe (prevented daily routine activity) and Grade 4 (ER visit/hospitalization). Grade 4 were classified by investigator or medically qualified person.
Percentage of Participants Reporting Adverse Events (AEs) Through 1 Month After Primary Dose: Non-Pregnant Participants Stage 1
Time frame: Day 1 (day of vaccination) through 1 Month post primary dose
An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. Examples of AEs included but were not limited to abnormal test findings; clinically significant signs and symptoms; changes in physical examination findings; hypersensitivity; progression/worsening of underlying disease; drug abuse; drug dependency.
Percentage of Participants Reporting AEs Through 1 Month After Booster Dose: Non-Pregnant Participants Stage 1
Time frame: Day 1 (day of vaccination) through 1 Month post booster dose
An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. Examples of AEs included but were not limited to abnormal test findings; clinically significant signs and symptoms; changes in physical examination findings; hypersensitivity; progression/worsening of underlying disease; drug abuse; drug dependency.
Percentage of Participants Reporting Medically Attended Adverse Events (MAEs) Through 6 Months After Primary Dose: Non-Pregnant Participants Stage 1
Time frame: Day 1 (day of vaccination) through 6 Months post primary dose
An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. Examples of AEs included but were not limited to abnormal test findings; clinically significant signs and symptoms; changes in physical examination findings; hypersensitivity; progression/worsening of underlying disease; drug abuse; drug dependency. A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility.
Percentage of Participants Reporting Serious Adverse Events (SAEs) Through 6 Months After Primary Dose: Non-Pregnant Participants Stage 1
Time frame: Day 1 (day of vaccination) through 6 Months post primary dose
An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. Examples of AEs included but were not limited to abnormal test findings; clinically significant signs and symptoms; changes in physical examination findings; hypersensitivity; progression/worsening of underlying disease; drug abuse; drug dependency. A SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); congenital anomaly/birth defect; or that was considered as an important medical event.
Percentage of Participants Reporting MAEs Approximately 7 to 12 Months After Booster Dose: Non-Pregnant Participants Stage 1
Time frame: Day 1 (day of vaccination) through approximately 7 to 12 months post booster dose
An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. Examples of AEs included but were not limited to abnormal test findings; clinically significant signs and symptoms; changes in physical examination findings; hypersensitivity; progression/worsening of underlying disease; drug abuse; drug dependency. A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility.
Percentage of Participants Reporting SAEs Approximately 7 to 12 Months After Booster Dose: Non-Pregnant Participants Stage 1
Time frame: Day 1 (day of vaccination) through approximately 7 to 12 months post booster dose
An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. Examples of AEs included but were not limited to abnormal test findings; clinically significant signs and symptoms; changes in physical examination findings; hypersensitivity; progression/worsening of underlying disease; drug abuse; drug dependency. A SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); congenital anomaly/birth defect; or that was considered as an important medical event.
Number of Participants With Clinical Laboratory Abnormalities at 2 Week Follow-up Visit: Maternal Participants Stage 2
Time frame: 2 weeks after vaccination in Stage 2
Hemoglobin: Grade 1, Platelets High: Grade 2, White blood cells decreased: Grade 1, Neutrophils (Absolute): Grade 1, Basophils (Absolute): Grade 2, Lymphocytes Low (Absolute): Grade1, Blood urea nitrogen (bun): Grade 1, Aspartate aminotransferase (AST): Grade 2, Alanine aminotransferase (ALT): Grade 1 and 3 and Alkaline phosphate: Grade 1. Grades were considered as 1: mild, 2: moderate, 3: severe. Only categories with non-zero values were reported for this outcome measure.
Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2
Time frame: Day 1 (day of vaccination) to Day 7 after Vaccination
Local reactions (redness, swelling, and pain at the injection site of the left arm) were recorded by participants in e-diary. Erythema/Redness and induration/swelling were measured and recorded in measuring device units (1 measuring device unit=0.5 cm). Grading: Grade 1/mild (> 2.5 to 5.0 cm), Grade 2/moderate (>5.0 to 10.0 cm), Grade 3/severe (>10.0 cm) and Grade 4 (necrosis [swelling] or necrosis or exfoliative dermatitis [redness]). Pain at injection site was graded as Grade 1/mild (did not interfere with activity), Grade2/moderate (interfered with activity), Grade 3/severe (prevented daily activity) and Grade 4 (ER visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person.
Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 3
Time frame: Day 1 (day of vaccination) to Day 7 after Vaccination
Local reactions (redness, swelling, and pain at the injection site of the left arm) were recorded by participants in e-diary. Erythema/Redness and induration/swelling were measured and recorded in measuring device units (1 measuring device unit=0.5 cm). Grading: Grade 1/mild (> 2.5 to 5.0 cm), Grade 2/moderate (>5.0 to 10.0 cm), Grade 3/severe (>10.0 cm) and Grade 4 (necrosis [swelling] or necrosis or exfoliative dermatitis [redness]). Pain at injection site was graded as Grade 1/mild (did not interfere with activity), Grade2/moderate (interfered with activity), Grade 3/severe (prevented daily activity) and Grade 4 (ER visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person.
Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2
Time frame: Day 1 (day of vaccination) to Day 7 after Vaccination
Systemic events were recorded in e-diary. Fever: oral temperature >=38.0 deg C and categorized as >=38.0-38.4 deg C, >38.4-38.9 deg C, >38.9-40.0 deg C and >40.0 deg C. Nausea/vomiting was graded as: Grade 1/mild (1-2 times in 24 h), Grade 2/moderate: (>2 times in 24h), Grade 3/severe (required intravenous hydration) and Grade 4 (ER visit/hospitalization for hypotensive shock). Diarrhea was graded as: Grade 1/mild (2-3 loose stools in 24h), Grade 2/moderate (4-5 loose stools in 24h), Grade 3/severe (6 or more loose stools in 24h) and Grade 4 (ER visit/hospitalization for severe diarrhea). Fatigue/tiredness, headache, muscle pain and joint pain were graded as: Grade 1/mild (did not interfere with activity), Grade 2/moderate (some interference with activity), Grade 3/severe (prevented daily routine activity) and Grade 4 (ER visit/hospitalization). Grade 4 were classified by investigator or medically qualified person.
Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 3
Time frame: Day 1 (day of vaccination) to Day 7 after Vaccination
Systemic events were recorded in e-diary. Fever: oral temperature >=38.0 deg C and categorized as >=38.0-38.4 deg C, >38.4-38.9 deg C, >38.9-40.0 deg C and >40.0 deg C. Nausea/vomiting was graded as: Grade 1/mild (1-2 times in 24 h), Grade 2/moderate: (>2 times in 24h), Grade 3/severe (required intravenous hydration) and Grade 4 (ER visit/hospitalization for hypotensive shock). Diarrhea was graded as: Grade 1/mild (2-3 loose stools in 24h), Grade 2/moderate (4-5 loose stools in 24h), Grade 3/severe (6 or more loose stools in 24h) and Grade 4 (ER visit/hospitalization for severe diarrhea). Fatigue/tiredness, headache, muscle pain and joint pain were graded as: Grade 1/mild (did not interfere with activity), Grade 2/moderate (some interference with activity), Grade 3/severe (prevented daily routine activity) and Grade 4 (ER visit/hospitalization). Grade 4 were classified by investigator or medically qualified person.
Percentage of Participants Reporting AEs Through 1 Month After Administration of Investigational Product: Maternal Participants Stage 2
Time frame: Day 1 (day of vaccination) through 1 Month post vaccination
An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. Examples of AEs included but were not limited to abnormal test findings; clinically significant signs and symptoms; changes in physical examination findings; hypersensitivity; progression/worsening of underlying disease; drug abuse; drug dependency.
Percentage of Participants Reporting AEs Through 1 Month After Administration of Investigational Product: Maternal Participants Stage 3
Time frame: Day 1 (day of vaccination) through 1 Month post vaccination
An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. Examples of AEs included but were not limited to abnormal test findings; clinically significant signs and symptoms; changes in physical examination findings; hypersensitivity; progression/worsening of underlying disease; drug abuse; drug dependency.
Percentage of Participants With SAEs From Day 1 Through 12 Months Post-delivery: Maternal Participants Stage 2
Time frame: Day 1 (day of vaccination) through 12 Month post delivery
An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. Examples of AEs included but were not limited to abnormal test findings; clinically significant signs and symptoms; changes in physical examination findings; hypersensitivity; progression/worsening of underlying disease; drug abuse; drug dependency. A SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); congenital anomaly/birth defect; or that was considered as an important medical event.
Percentage of Participants With SAEs From Day 1 Through 12 Months Post-delivery: Maternal Participants Stage 3
Time frame: Day 1 (day of vaccination) through 12 Month post delivery
An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. Examples of AEs included but were not limited to abnormal test findings; clinically significant signs and symptoms; changes in physical examination findings; hypersensitivity; progression/worsening of underlying disease; drug abuse; drug dependency. A SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); congenital anomaly/birth defect; or that was considered as an important medical event.
Percentage of Participants With MAEs From Day 1 Through 12 Months Post-delivery: Maternal Participants Stage 2
Time frame: Day 1 (day of vaccination) through 12 Month post delivery
An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. Examples of AEs included but were not limited to abnormal test findings; clinically significant signs and symptoms; changes in physical examination findings; hypersensitivity; progression/worsening of underlying disease; drug abuse; drug dependency. A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility.
Percentage of Participants With MAEs From Day 1 Through 12 Months Post-delivery: Maternal Participants Stage 3
Time frame: Day 1 (day of vaccination) through 12 Month post delivery
An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. Examples of AEs included but were not limited to abnormal test findings; clinically significant signs and symptoms; changes in physical examination findings; hypersensitivity; progression/worsening of underlying disease; drug abuse; drug dependency. A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility.
Percentage of Participants With Obstetric Complications From Visit 1 Through 12 Months Post-delivery: Maternal Participants Stage 2
Time frame: Day 1 (day of vaccination) through 12 Month post delivery
Obstetric complications such as: prepartum period, intrapartum period and postpartum period were reported in this outcome measure.
Percentage of Participants With Obstetric Complications From Day 1 Through 12 Months Post-delivery: Maternal Participants Stage 3
Time frame: Day 1 (day of vaccination) through 12 Month post delivery
Obstetric complications such as: prepartum period, intrapartum period and postpartum period were reported in this outcome measure.
Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 2
Time frame: At delivery
Delivery Outcome included full term live delivery, premature live delivery, Stillbirth, induced/elective abortion and unknown. Mode of delivery included: vaginal delivery, Cesarean section: elective, semi-elective and emergency were reported in this outcome measure.
Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 3
Time frame: At delivery
Delivery Outcome included full term live delivery, premature live delivery, Stillbirth, induced/elective abortion and unknown. Mode of delivery included: vaginal delivery, Cesarean section: elective, semi-elective and emergency were reported in this outcome measure.
Percentage of Participants With Gestational Age at Birth: Infant Participants Stage 2
Time frame: At Birth
Gestational age of participants at birth in weeks included: greater than or equal to (>=)24 weeks to less than (<) 28 weeks, >=28 weeks to <34 weeks, >=34 weeks to <37 weeks, >=37 weeks to <42 weeks, >=42 weeks.
Appearance, Pulse, Grimace, Activity, and Respiration (APGAR) Score at 1 Minute: Infant Participants Stage 2
Time frame: At 1 minute of Birth
APGAR is a scoring system that evaluates Activity, Pulse, Grimace, Appearance, and Respiration. Each category is given a score of 0-2 points (with 0 being absent and 2 being normal), the points are then combined for a total score that ranges from 0-10. Scores 7 and above are generally normal, 4 to 6 are fairly low, and 2 and below are considered critically low. APGAR score at 1 minute were reported in this outcome measure.
Appearance, Pulse, Grimace, Activity, and Respiration (APGAR) Score at 5 Minutes: Infant Participants Stage 2
Time frame: At 5 minutes of Birth
APGAR is a scoring system that evaluates Activity, Pulse, Grimace, Appearance, and Respiration. Each category is given a score of 0-2 points (with 0 being absent and 2 being normal), the points are then combined for a total score that ranges from 0-10. Scores 7 and above are generally normal, 4 to 6 are fairly low, and 2 and below are considered critically low. APGAR score at 5 minute were reported in this outcome measure.
Number of Participants According to Age Determined by Ballard Score: Infant Participants Stage 2
Time frame: At Birth
The Ballard score is a commonly used technique of gestational age assessment. It assists healthcare providers in determining if an infant is premature, on time, or post-term based on physical traits. This scoring allows for the estimation of age in the range of 26 weeks to 44 weeks Participants according to age determined by Ballard score: at <37 weeks 0 days, >=37 weeks to <42 weeks, >=42 weeks were reported in this outcome measure. Ballard score was not conducted routinely/mandatory.
Number of Participants With Newborn Assessment at Birth: Infant Participants Stage 2
Time frame: At Birth
Participants with newborn assessment at birth included: normal, congenital malformation/anomaly, other neonatal problem were reported in this outcome measure.
Number of Participants With Vital Status: Infant Participants Stage 2
Time frame: At Birth
Participants according to vital status as: live or neonatal death were reported in this outcome measure.
Number of Participants With Gestational Age of Participants at Birth: Infant Participants Stage 3
Time frame: At 1 minute of Birth
Gestational age of participants at birth in weeks included: greater than or equal to (>=)24 weeks to less than (<) 28 weeks, >=28 weeks to <34 weeks, >=34 weeks to <37 weeks, >=37 weeks to <42 weeks, >=42 weeks.
Appearance, Pulse, Grimace, Activity, and Respiration (APGAR) Score at 1 Minute: Infant Participants Stage 3
Time frame: At 1 minute of Birth
APGAR is a scoring system that evaluates Activity, Pulse, Grimace, Appearance, and Respiration. Each category is given a score of 0-2 points (with 0 being absent and 2 being normal), the points are then combined for a total score that ranges from 0-10. Scores 7 and above are generally normal, 4 to 6 are fairly low, and 2 and below are considered critically low. Appearance, pulse, grimace, activity, and respiration (APGAR) score at 1 minute were reported in this outcome measure.
APGAR Score at 5 Minutes: Infant Participants Stage 3
Time frame: At 5 minutes of Birth
APGAR is a scoring system that evaluates Activity, Pulse, Grimace, Appearance, and Respiration. Each category is given a score of 0-2 points (with 0 being absent and 2 being normal), the points are then combined for a total score that ranges from 0-10. Scores 7 and above are generally normal, 4 to 6 are fairly low, and 2 and below are considered critically low. Appearance, pulse, grimace, activity, and respiration (APGAR) score at 5 minute were reported in this outcome measure.
Number of Participants According to Age Determined by Ballard Score: Infant Participants Stage 3
Time frame: At Birth
The Ballard score is a commonly used technique of gestational age assessment. It assists healthcare providers in determining if an infant is premature, on time, or post-term based on physical traits. This scoring allows for the estimation of age in the range of 26 weeks to 44 weeks Participants according to age determined by Ballard score: at <37 weeks 0 days, >=37 weeks to <42 weeks, >=42 weeks were reported in this outcome measure. Ballard score was not conducted routinely/mandatory.
Number of Participants With Newborn Assessment at Birth: Infant Participants Stage 3
Time frame: At 5 minutes of Birth
Participants with newborn assessment at birth included: normal, congenital malformation/anomaly, other neonatal problem were reported in this outcome measure.
Number of Participants With Vital Status: Infant Participants Stage 3
Time frame: At Birth
Participants according to vital status as: live or neonatal death were reported in this outcome measure.
Number of Participants With AEs From Birth to 6 Weeks of Age: Infant Participants Stage 2
Time frame: From Birth to 6 Weeks
An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage.
Numberof Participants With AEs From Birth to 6 Weeks of Age: Infant Participants Stage 3
Time frame: From Birth to 6 Weeks
An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage.
Number of Participants With SAEs From Birth to 12 Months of Age: Infant Participants Stage 2
Time frame: From Birth to 12 Months
An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. A SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); congenital anomaly/birth defect; or that was considered as an important medical event.
Number of Participants With SAEs From Birth to 12 Months of Age: Infant Participants Stage 3
Time frame: From Birth to 12 Months
An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. A SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); congenital anomaly/birth defect; or that was considered as an important medical event.
Number of Participants With MAEs From Birth to 12 Months of Age: Infant Participants Stage 2
Time frame: From Birth to 12 Months
An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility.
Number of Participants With MAEs From Birth to 12 Months of Age: Infant Participants Stage 3
Time frame: From Birth to 12 Months
An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility.
Percentage of Participants With Adverse Events of Special Interest From Birth to 12 Months of Age: Infant Participants Stage 2
Time frame: From Birth to 12 Months
An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. AEs of special interest included: major congenital anomalies, developmental delay and suspected or confirmed GBS infection.
Percentage of Participants With Adverse Events of Special Interest From Birth to 12 Months of Age: Infant Participants Stage 3
Time frame: From Birth to 12 Months
An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. AEs of special interest included: major congenital anomalies, developmental delay and suspected or confirmed GBS infection.
10 secondary outcomes
Geometric Mean Concentration (GMCs) of Group B Streptococcus (GBS) Serotype-Specific Immunoglobulin G (IgG) at 1 Month After Primary Dose: Non-Pregnant Women Stage 1
Time frame: At 1 Month After primary Dose
GMCs of GBS Serotype-specific IgG Before and 1 Month, 3 Months, and 6 Months After a Booster Dose: Non Pregnant Women Stage 1
Time frame: Before (immediately before booster vaccination) and at 1, 3 and 6 Months After vaccination as Booster Dose
GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2
Time frame: At 2 Weeks after Vaccination, 1 Month After Vaccination and at Delivery
GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 3
Time frame: At 2 Weeks after Vaccination, 1 Month After Vaccination and at Delivery
GBS6 Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2
Time frame: At 1 Month After Vaccination and at Delivery
GBS6 Serotype-Specific OPA Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 3
Time frame: At 1 Month After Vaccination and at Delivery
GMCs of GBS6 Serotype-Specific IgG Infant Participant at Birth: Infant Participants Stage 2
Time frame: At Birth
GMCs of GBS6 Serotype-Specific IgG Infant Participant at Birth: Infant Participants Stage 3
Time frame: At Birth
GBS6 Serotype-Specific OPA GMTs Measured at Birth: Infant Participants Stage 2
Time frame: At Birth
GBS6 Serotype-Specific OPA GMTs Measured at Birth: Infant Participants Stage 3
Time frame: At Birth
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42521820Madhi SA, Snaggs H, Skogeby Z, Feng Y, Barnabas S, Baker J, Fairlie L, Beeslaar J, Radley D, Jiang HQ, Silmon de Monerri NC, Simon R, McLaughlin L, Gaylord M, Skinner J, Munjal I, Anderson AS, Gurtman A. Maternal 6-valent group B Streptococcus vaccine in non-pregnant and pregnant females: a randomized phase 1/2 trial. Nat Med. 2026 Aug;32(8):3048-3059. doi: 10.1038/s41591-026-04558-5. Epub 2026 Jul 28.
- Derived from this study: PubMed 38310014Cutland CL, Sawry S, Fairlie L, Barnabas S, Frajzyngier V, Roux JL, Izu A, Kekane-Mochwari KE, Vika C, De Jager J, Munson S, Jongihlati B, Stark JH, Absalon J. Obstetric and neonatal outcomes in South Africa. Vaccine. 2024 Feb 27;42(6):1352-1362. doi: 10.1016/j.vaccine.2024.01.054. Epub 2024 Feb 3.
- Derived from this study: PubMed 37467497Madhi SA, Anderson AS, Absalon J, Radley D, Simon R, Jongihlati B, Strehlau R, van Niekerk AM, Izu A, Naidoo N, Kwatra G, Ramsamy Y, Said M, Jones S, Jose L, Fairlie L, Barnabas SL, Newton R, Munson S, Jefferies Z, Pavliakova D, Silmon de Monerri NC, Gomme E, Perez JL, Scott DA, Gruber WC, Jansen KU. Potential for Maternally Administered Vaccine for Infant Group B Streptococcus. N Engl J Med. 2023 Jul 20;389(3):215-227. doi: 10.1056/NEJMoa2116045.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
35 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Multivalent Group B streptococcus vaccine in people with Group B Streptococcus Infections, run by Pfizer at 35 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in United States, South Africa, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Reporting Local Reactions Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 (time frame: Day 1 (day of vaccination) to Day 7 after Primary Dose). The study lists 45 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03765073, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2025; AzTrials last refreshed its copy on 7 Nov 2026.