GBS DiseasePhase 2NCT02046148
Safety and Immunogenicity of a Trivalent Group B Streptococcus Vaccine in Healthy Pregnant Women
A Phase 2 study testing GBS trivalent vaccine in people with GBS Disease and Streptococcus Agalactiae, run by GlaxoSmithKline at 6 sites in United States.
Trial summary
Evaluate the safety and immunogenicity of the trivalent group B streptococcus vaccine in healthy pregnant women. The study will also evaluate the levels of GBS serotype-specific antibodies in infants, placental transfer from the pregnant women to the infant and levels of antibodies in the breast milk. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- GBS Disease, Streptococcus Agalactiae
- What is being tested?
- GBS trivalent vaccine
- Type of treatment
- Vaccines, Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 6 sitesUnited States
- Study dates
- 18 Mar 2014to 26 Mar 2016
- 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 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Healthy pregnant women 18-40 years of age, inclusive and at 24 0/7 through 34 6/7 weeks gestation.
- Individuals who intend to breastfeed for at least 90 days postpartum.
- Individuals who have given written consent after the nature of the study has been explained according to local regulatory requirements.
- Individuals in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator.
- Individuals who can comprehend and comply with all study procedures and are available for follow-up.
Who cannot join
- Individuals with history of illness or an ongoing illness that, in the opinion of the investigator, may pose additional risk to the subject if she participates in the study.
- Individuals with known hypersensitivity to any component of the vaccine.
- Individuals who received or plan to receive any licensed vaccine within 14 days before or after the study vaccine with the exception of inactivated influenza vaccine which may be administered up to 7 days before or after study vaccine.
- Individuals with an infection requiring systemic antibiotic or antiviral treatment within 7 days prior to Study Day 1.
- Individuals determined as high risk for serious obstetrical complication, including:
- Gestational hypertension, as defined by American College of Obstetricians and Gynecologists guidelines (ACOG Practice Bulletin 2012)
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- Gestational diabetes which is not controlled by diet and exercise as per American College of Obstetricians and Gynecologists guidelines (ACOG Practice Bulletin 2013)
- Pre-eclampsia or eclampsia as defined by American College of Obstetricians and Gynecologists guidelines (ACOG practice bulletin, 2002)
- HIV infection
- Obesity class II or greater (pre-pregnancy BMI≥35.0)
- multiple pregnancy
- Individuals with behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the subject's ability to participate in the study.
- Individuals who are not able to comprehend and to follow all required study procedures for the whole period of the study.
- Individuals with known or suspected impairment of the immune system including known or suspected HIV infection or HIV-related disease, a history of or an active autoimmune disorder and receipt of immunosuppressive therapy.
- Long term use of glucocorticoids, including oral or parenteral prednisone ≥ 20 mg/day or equivalent for more than 2 consecutive weeks (or 2 weeks total) within 30 days prior to enrollment. Use of inhaled, intranasal, or topical corticosteroids is allowed.
- Individuals participating in any clinical trial with another investigational product during the pregnancy or intent to participate in another clinical study at any time during the conduct of this study.
- Pregnant with a fetus with a known or suspected congenital anomaly
- Individuals who are acting as study personnel or immediate family members (brother, sister, child, parent) or the spouse of study personnel.
- Individuals with a fever (oral temperature ≥ 38°C/100.4 °F) within 3 days prior to intended study vaccination.
- Individuals with a history of culture confirmed GBS case in the infant(s) previously born to her.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
GSK Investigational Site
Aurora, Colorado, 80045
GSK Investigational Site
Baltimore, Maryland, 21201
GSK Investigational Site
Charleston, South Carolina, 29425
GSK Investigational Site
Durham, North Carolina, 27705
GSK Investigational Site
Nashville, Tennessee, 37232
GSK Investigational Site
Pittsburgh, Pennsylvania, 15213
About this study
Official title: A Phase II, Multicenter, Randomized, Observer-Blind, Controlled Study to Evaluate Safety and Immunogenicity of a Trivalent Group B Streptococcus Vaccine in Healthy Pregnant Women
Evaluate the safety and immunogenicity of the trivalent group B streptococcus vaccine in healthy pregnant women. The study will also evaluate the levels of GBS serotype-specific antibodies in infants, placental transfer from the pregnant women to the infant and levels of antibodies in the breast milk.
- Conditions
- GBS Disease, Streptococcus Agalactiae
- Being tested
- GBS trivalent vaccine, Placebo
- Keywords
- Maternal vaccine, IgG, IgA, GBS, pregnant women
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GBS trivalent vaccineBiological
Intramuscular injection - Liquid formulation of a vaccine containing polysaccharide capsules from serotypes Ia, Ib, and III of the Group B Streptococcus and conjugated to the Corynebacterium diphtheriae CRM197 carrier protein
PlaceboBiological
Intramuscular injection - Normal saline
| Study group | Role | What they receive |
|---|---|---|
| GBS Group | Experimental | Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Group B Streptococcus (GBS) trivalent vaccine, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum). Receives: Biological: GBS trivalent vaccine |
| Placebo Group | Active comparator | Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Placebo, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum). Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of Serotype Ia GBS IgG Levels in Infant Serum at Delivery and at Days 42 and 90 of Age
To evaluate serotype-specific Ia GBS serum IgG antibody levels (anti-Ia) in infants born to maternal subjects receiving the GBS trivalent vaccine, as measured at birth, Day 42 and Day 90 of age. Antibody concentrations were measured by Enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL).
Measured: At Birth, Day 42 and Day 90
Concentration of Serotype Ib GBS IgG Levels in Infant Serum at Delivery and at Days 42 and 90 of Age
To evaluate serotype-specific Ib GBS serum IgG antibody levels (anti-Ib) in infants born to maternal subjects receiving the GBS trivalent vaccine, as measured at birth, Day 42 and Day 90 of age. As the singleton ELISA was no longer in use at the time of serotypes Ib and III testing, results for both serotypes were tested using multiplex immunoassay
Measured: At Birth, Day 42 and Day 90
Concentration of Serotype III GBS IgG Levels in Infant Serum at Delivery and at Days 42 and 90 of Age
To evaluate serotype-specific III GBS serum IgG antibody levels (anti-III) in infants born to maternal subjects receiving the GBS trivalent vaccine, as measured at birth, Day 42 and Day 90 of age. As the singleton ELISA was no longer in use at the time of serotypes Ib and III testing, results for both serotypes were tested using multiplex immunoassay.
Measured: At Birth, Day 42 and Day 90
Concentration of Serotype Ia GBS IgG Levels in Maternal Serum at Pre-vaccination, at Study Day 31, at Delivery and at Days 42 and 90 Postpartum
To evaluate serotype-specific (Ia) GBS serum IgG antibody levels (anti-Ia) in maternal subjects. Antibody concentrations were measured by Enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL).
Measured: At Day 1 (pre-vaccination), Day 31 (post-vaccination), Delivery, Days 42 and 90 (postpartum)
Concentration of Serotype Ib GBS IgG Levels in Maternal Serum at Pre-vaccination, at Study Day 31, at Delivery and at Days 42 and 90 Postpartum
To evaluate serotype-specific (Ib) GBS serum IgG antibody levels (anti-Ib) in maternal subjects. As the singleton ELISA was no longer in use at the time of serotypes Ib and III testing, results for both serotypes were tested using multiplex immunoassay.
Measured: At Day 1 (pre-vaccination), Day 31 (post-vaccination), Delivery, Days 42 and 90 (postpartum)
Concentration of Serotype III GBS IgG Levels in Maternal Serum at Pre-vaccination, at Study Day 31, at Delivery and at Days 42 and 90 Postpartum
To evaluate serotype-specific (III) GBS serum IgG antibody levels (anti-III) in maternal subjects. As the singleton ELISA was no longer in use at the time of serotypes Ib and III testing, results for both serotypes were tested using multiplex immunoassay.
Measured: At Day 1 (pre-vaccination), Day 31 (post-vaccination), Delivery, Days 42 and 90 (postpartum)
Ratio Relative to Pre-vaccination Levels of Maternal Serum GBS IgG Antibody Levels - Serotype Ia, as Measured at Study Day 31, at Delivery and at Days 42 and 90 Postpartum
Geometric Mean Ratio relative to pre-vaccination (Day 1) of serotype-specific (Ia) GBS serum IgG antibody concentrations (anti-Ia) in maternal subjects. Antibody concentrations were measured by Enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL).
Measured: At Day 31 (post-vaccination), Delivery, Days 42 and 90 (postpartum)
Ratio Relative to Pre-vaccination Levels of Maternal Serum GBS IgG Antibody Levels - Serotype Ib, as Measured at Study Day 31, at Delivery and at Days 42 and 90 Postpartum
Geometric Mean Ratio relative to pre-vaccination (Day 1) of serotype-specific (Ib) GBS serum IgG antibody concentrations (anti-Ib) in maternal subjects. As the singleton ELISA was no longer in use at the time of serotypes Ib and III testing, results for both serotypes were tested using multiplex immunoassay.
Measured: At Day 31 (post-vaccination), Delivery, Days 42 and 90 (postpartum)
Ratio Relative to Pre-vaccination Levels of Maternal Serum GBS IgG Antibody Levels - Serotype III, as Measured at Study Day 31, at Delivery and at Days 42 and 90 Postpartum
Geometric Mean Ratio relative to pre-vaccination (Day 1) of serotype-specific (III) GBS serum IgG antibody concentrations (anti-III) in maternal subjects. As the singleton ELISA was no longer in use at the time of serotypes Ib and III testing, results for both serotypes were tested using multiplex immunoassay.
Measured: At Day 31 (post-vaccination), Delivery, Days 42 and 90 (postpartum)
Secondary outcomes (19)
Ratio of GBS IgG Antibody Levels - Serotype Ia in Infant Serum Relative to Maternal Serum at the Time of Delivery
To evaluate the relationship of serotype-specific Ia GBS IgG antibody levels (anti-Ia) in the infant serum to the GBS IgG antibody levels in the maternal serum at the time of delivery/birth. Antibody concentrations were measured by Enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL).
Measured: At Delivery
Ratio of GBS IgG Antibody Levels - Serotype Ib in Infant Serum Relative to Maternal Serum at the Time of Delivery
To evaluate the relationship of serotype-specific Ib GBS IgG antibody levels (anti-Ib) in the infant serum to the GBS IgG antibody levels in the maternal serum at the time of delivery/birth. As the singleton ELISA was no longer in use at the time of serotypes Ib and III testing, results for both serotypes were tested using multiplex immunoassay.
Measured: At Delivery
Ratio of GBS IgG Antibody Levels - Serotype III in Infant Serum Relative to Maternal Serum at the Time of Delivery
To evaluate the relationship of serotype-specific III GBS IgG antibody levels (anti-III) in the infant serum to the GBS IgG antibody levels in the maternal serum at the time of delivery/birth. As the singleton ELISA was no longer in use at the time of serotypes Ib and III testing, results for both serotypes were tested using multiplex immunoassay.
Measured: At Delivery
Percentage of Maternal Subjects With Solicited Local and Solicited Systemic Adverse Events (AEs) up to 30 Minutes
Percentage and frequency of maternal subjects with solicited local and solicited systemic AEs up to Study Day 7 and calculated for four time intervals after vaccination: 30 minutes, Study Days 1-3 (without 30 min), Study Days 4-7, Study Days 1-7 (without 30 min). Threshold for Ecchymosis, Erythema, Swelling and Induration: Grade 0 (<25 mm), Any (≥ 25 mm). Systemic fever includes subjects with body temperature ≥ 38 °C irrespective of route of measurement.
Measured: Up to 30 minutes post-vaccination
Percentage of Maternal Subjects With Solicited Local and Solicited Systemic AEs - Study Days 1-3
Percentage and frequency of maternal subjects with solicited local and solicited systemic AEs up to Study Day 7 and calculated for four time intervals after vaccination: 30 minutes, Study Days 1-3 (without 30 min), Study Days 4-7, Study Days 1-7 (without 30 min). Threshold for Ecchymosis, Erythema, Swelling and Induration: Grade 0 (<25 mm), Any (≥ 25 mm). Systemic fever includes subjects with body temperature ≥ 38 °C irrespective of route of measurement.
Measured: During Study Days 1-3 (from 6 hours through Day 3 post-vaccination)
Percentage of Maternal Subjects With Solicited Local and Solicited Systemic AEs - Study Days 4-7
Percentage and frequency of maternal subjects with solicited local and solicited systemic AEs up to Study Day 7 and calculated for four time intervals after vaccination: 30 minutes, Study Days 1-3 (without 30 min), Study Days 4-7, Study Days 1-7 (without 30 min). Threshold for Ecchymosis, Erythema, Swelling and Induration: Grade 0 (<25 mm), Any (≥ 25 mm). Systemic fever includes subjects with body temperature ≥ 38 °C irrespective of route of measurement.
Measured: During Study Days 4-7
Percentage of Maternal Subjects With Solicited Local and Solicited Systemic AEs - Study Days 1-7
Percentage and frequency of maternal subjects with solicited local and solicited systemic adverse events up to Study Day 7 and calculated for four time intervals after vaccination: 30 minutes, Study Days 1-3 (without 30 min), Study Days 4-7, Study Days 1-7 (without 30 min). Threshold for Ecchymosis, Erythema, Swelling and Induration: Grade 0 (<25 mm), Any (≥ 25 mm). Systemic fever includes subjects with body temperature ≥ 38 °C irrespective of route of measurement.
Measured: During Study Days 1-7 (from 6 hours through Day 7 post-vaccination)
Percentage of Maternal Subjects With Any Unsolicited AEs
An AE is defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product at any dose that does not necessarily have to have a causal relationship with this treatment. Therefore, an AE can be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of an investigational product, whether or not considered related to the investigational product. This definition includes inter-current illnesses or injuries and exacerbation of pre-existing conditions.
Measured: From Study Day 1 through Study Day 31
Percentage of Maternal Subjects With Serious Adverse Events (SAEs), Unsolicited Medically Attended AEs (MAEs) and Unsolicited AEs Leading to Study Withdrawal (AEs Lead. Wthwal)
An SAE is defined as any untoward medical occurrence that at any dose results in one or more of the following: death; life-threatening; that does not refer to an event which hypothetically might have caused death if it were more severe; required or prolonged hospitalization; persistent or significant disability/incapacity; congenital anomaly/or birth defect; any important and significant medical event that may not be immediately life-threatening or resulting in death or hospitalization but, based upon appropriate medical judgement, may jeopardize the subject or may require intervention to prevent one of the other outcomes listed above. An MAE is defined as an adverse event that leads to an unscheduled visit to a healthcare practitioner.
Measured: From Study Day 1 through Study Day 31
Percentage of Maternal Subjects With SAEs, Unsolicited MAEs and Unsolicited AEs Leading to Study Withdrawal (AEs Lead. Wthwal)
An SAE is defined as any untoward medical occurrence that at any dose results in one or more of the following: death; life-threatening; that does not refer to an event which hypothetically might have caused death if it were more severe; required or prolonged hospitalization; persistent or significant disability/incapacity; congenital anomaly/or birth defect; any important and significant medical event that may not be immediately life-threatening or resulting in death or hospitalization but, based upon appropriate medical judgement, may jeopardize the subject or may require intervention to prevent one of the other outcomes listed above. An MAE is defined as an adverse event that leads to an unscheduled visit to a healthcare practitioner.
Measured: From Study Day 32 through Day 180 postpartum
Percentage of Infants With SAEs, Unsolicited MAEs and AEs Leading to Study Withdrawal
An SAE is defined as any untoward medical occurrence that at any dose results in one or more of the following: death; life-threatening; that does not refer to an event which hypothetically might have caused death if it were more severe; required or prolonged hospitalization; persistent or significant disability/incapacity; congenital anomaly/or birth defect; any important and significant medical event that may not be immediately life-threatening or resulting in death or hospitalization but, based upon appropriate medical judgement, may jeopardize the subject or may require intervention to prevent one of the other outcomes listed above. An MAE is defined as an adverse event that leads to an unscheduled visit to a healthcare practitioner.
Measured: From Birth through Day 180 of age
Birth Weight of Infants (Mean-Standard Deviation)
Weight at birth was summarized by reporting the mean and standard deviation,
Measured: At Birth
Birth Weight of Infants (Median, Minimum and Maximum)
Weight at birth was summarized by reporting the median and the minimum and maximum.
Measured: At Birth
Birth Length and Head Circumference of Infants (Mean - Standard Deviation)
Length and head circumference at birth were summarized by reporting the mean and standard deviation.
Measured: At Birth
Birth Length and Head Circumference of Infants (Median - Minimum and Maximum)
Length and head circumference at birth were summarized by reporting the median and minimum and maximum
Measured: At birth
Infants Apgar Scores (Mean - Standard Deviation)
Apgar (Appearance, Pulse, Grimace response, Activity and Respiration) test to evaluate the new-born's physical condition. Apgar score between 0 and 10 (highest score possible). If 1 and 5 minutes Apgar score were normal, 10 minutes Apgar score might not be required.
Measured: At 1, 5 and 10 minutes
Infants Apgar Scores (Median, Minimum and Maximum)
Apgar (Appearance, Pulse, Grimace response, Activity and Respiration) test to evaluate the new-born's physical condition. Apgar scores between 0 and 10 (highest score possible). If 1 and 5 minutes Apgar score were normal, 10 minutes Apgar score might not be required.
Measured: At 1, 5 and 10 minutes
Descriptive Statistics for the Score for the Long-term Developmental Outcome Assessed by Bayley Scales of Infant and Toddler Development 3rd Edition Screening Test (PsychCorp) in Infants (Mean - Standard Deviation)
Long-term developmental outcome assessed by Bayley Scales of Infant and Toddler Development 3rd edition Screening Test (PsychCorp). The screening test measured three domains: cognitive, language (receptive vs expressive communication), and motor (fine vs gross). Scaled scores range from 1 to 19 with a mean of 10 and a standard deviation of 3. The scores were summarized by reporting the mean and standard deviation.
Measured: At Day 180 of age
Descriptive Statistics for the Score for the Long-term Developmental Outcome Assessed by Bayley Scales of Infant and Toddler Development 3rd Edition Screening Test (PsychCorp) in Infants (Median, Minimum and Maximum)
Long-term developmental outcome assessed by Bayley Scales of Infant and Toddler Development 3rd edition Screening Test (PsychCorp). The screening test measured three domains: cognitive, language (receptive vs expressive communication), and motor (fine vs gross). Scaled scores range from 1 to 19 with a mean of 10 and a standard deviation of 3. The scores were summarized by reporting the median, minimum and maximum.
Measured: At Day 180 of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2014 (estimated)
- Study start18 Mar 2014
- Primary completion30 Dec 2015
- Study completion26 Mar 2016
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 (1)Papers the sponsor has linked to this study.
- Other trials for GBS DiseaseStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Novartis Vaccines
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02046148
- Sponsor's protocol ID
- 205235
- Other IDs
- V98_12
- Status last verified
- Dec 2020
- First submitted
- 21 Jan 2014
- Last updated
- 29 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: IPD for this study is available via the Clinical Study Data Request site.
Publications
Swamy GK, Metz TD, Edwards KM, Soper DE, Beigi RH, Campbell JD, Grassano L, Buffi G, Dreisbach A, Margarit I, Karsten A, Henry O, Lattanzi M, Bebia Z. Safety and immunogenicity of an investigational maternal trivalent group B streptococcus vaccine in pregnant women and their infants: Results from a randomized placebo-controlled phase II trial. Vaccine. 2020 Oct 14;38(44):6930-6940. doi: 10.1016/j.vaccine.2020.08.056. Epub 2020 Sep 1.
PubMed 32883555
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Multicenter, Randomized, Observer-Blind, Controlled Study to Evaluate Safety and Immunogenicity of a Trivalent Group B Streptococcus Vaccine in Healthy Pregnant Women
- ClinicalTrials.gov ID
- NCT02046148
- Acronym / sponsor ID
- 205235
- Conditions
- GBS Disease, Streptococcus Agalactiae
- Keywords
- Maternal vaccine, IgG, IgA, GBS, pregnant women
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Collaborators
- Novartis Vaccines
- Study start
- 18 Mar 2014 (actual)
- Primary completion
- 30 Dec 2015 (actual)
- Study completion
- 26 Mar 2016 (actual)
- First posted
- 27 Jan 2014 (estimated)
- Results
- Posted 30 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate the safety and immunogenicity of the trivalent group B streptococcus vaccine in healthy pregnant women. The study will also evaluate the levels of GBS serotype-specific antibodies in infants, placental transfer from the pregnant women to the infant and levels of antibodies in the breast milk.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GBS Group | Experimental | Biological: GBS trivalent vaccineHealthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Group B Streptococcus (GBS) trivalent vaccine, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum). |
| Placebo Group | Active comparator | Biological: PlaceboHealthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Placebo, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum). |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy pregnant women 18-40 years of age, inclusive and at 24 0/7 through 34 6/7 weeks gestation.
- Individuals who intend to breastfeed for at least 90 days postpartum.
- Individuals who have given written consent after the nature of the study has been explained according to local regulatory requirements.
- Individuals in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator.
- Individuals who can comprehend and comply with all study procedures and are available for follow-up.
Key exclusion criteria (20 listed)
- Individuals with history of illness or an ongoing illness that, in the opinion of the investigator, may pose additional risk to the subject if she participates in the study.
- Individuals with known hypersensitivity to any component of the vaccine.
- Individuals who received or plan to receive any licensed vaccine within 14 days before or after the study vaccine with the exception of inactivated influenza vaccine which may be administered up to 7 days before or after study vaccine.
- Individuals with an infection requiring systemic antibiotic or antiviral treatment within 7 days prior to Study Day 1.
- Individuals determined as high risk for serious obstetrical complication, including:
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 |
|---|---|---|
| GBS trivalent vaccineIntramuscular injection - Liquid formulation of a vaccine containing polysaccharide capsules from serotypes Ia, Ib, and III of the Group B Streptococcus and conjugated to the Corynebacterium diphtheriae CRM197 carrier protein | Biological | GBS Group |
| PlaceboIntramuscular injection - Normal saline | Biological | Placebo Group |
Primary outcome
Concentration of Serotype Ia GBS IgG Levels in Infant Serum at Delivery and at Days 42 and 90 of Age
Time frame: At Birth, Day 42 and Day 90
To evaluate serotype-specific Ia GBS serum IgG antibody levels (anti-Ia) in infants born to maternal subjects receiving the GBS trivalent vaccine, as measured at birth, Day 42 and Day 90 of age. Antibody concentrations were measured by Enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL).
Concentration of Serotype Ib GBS IgG Levels in Infant Serum at Delivery and at Days 42 and 90 of Age
Time frame: At Birth, Day 42 and Day 90
To evaluate serotype-specific Ib GBS serum IgG antibody levels (anti-Ib) in infants born to maternal subjects receiving the GBS trivalent vaccine, as measured at birth, Day 42 and Day 90 of age. As the singleton ELISA was no longer in use at the time of serotypes Ib and III testing, results for both serotypes were tested using multiplex immunoassay
Concentration of Serotype III GBS IgG Levels in Infant Serum at Delivery and at Days 42 and 90 of Age
Time frame: At Birth, Day 42 and Day 90
To evaluate serotype-specific III GBS serum IgG antibody levels (anti-III) in infants born to maternal subjects receiving the GBS trivalent vaccine, as measured at birth, Day 42 and Day 90 of age. As the singleton ELISA was no longer in use at the time of serotypes Ib and III testing, results for both serotypes were tested using multiplex immunoassay.
Concentration of Serotype Ia GBS IgG Levels in Maternal Serum at Pre-vaccination, at Study Day 31, at Delivery and at Days 42 and 90 Postpartum
Time frame: At Day 1 (pre-vaccination), Day 31 (post-vaccination), Delivery, Days 42 and 90 (postpartum)
To evaluate serotype-specific (Ia) GBS serum IgG antibody levels (anti-Ia) in maternal subjects. Antibody concentrations were measured by Enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL).
Concentration of Serotype Ib GBS IgG Levels in Maternal Serum at Pre-vaccination, at Study Day 31, at Delivery and at Days 42 and 90 Postpartum
Time frame: At Day 1 (pre-vaccination), Day 31 (post-vaccination), Delivery, Days 42 and 90 (postpartum)
To evaluate serotype-specific (Ib) GBS serum IgG antibody levels (anti-Ib) in maternal subjects. As the singleton ELISA was no longer in use at the time of serotypes Ib and III testing, results for both serotypes were tested using multiplex immunoassay.
Concentration of Serotype III GBS IgG Levels in Maternal Serum at Pre-vaccination, at Study Day 31, at Delivery and at Days 42 and 90 Postpartum
Time frame: At Day 1 (pre-vaccination), Day 31 (post-vaccination), Delivery, Days 42 and 90 (postpartum)
To evaluate serotype-specific (III) GBS serum IgG antibody levels (anti-III) in maternal subjects. As the singleton ELISA was no longer in use at the time of serotypes Ib and III testing, results for both serotypes were tested using multiplex immunoassay.
Ratio Relative to Pre-vaccination Levels of Maternal Serum GBS IgG Antibody Levels - Serotype Ia, as Measured at Study Day 31, at Delivery and at Days 42 and 90 Postpartum
Time frame: At Day 31 (post-vaccination), Delivery, Days 42 and 90 (postpartum)
Geometric Mean Ratio relative to pre-vaccination (Day 1) of serotype-specific (Ia) GBS serum IgG antibody concentrations (anti-Ia) in maternal subjects. Antibody concentrations were measured by Enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL).
Ratio Relative to Pre-vaccination Levels of Maternal Serum GBS IgG Antibody Levels - Serotype Ib, as Measured at Study Day 31, at Delivery and at Days 42 and 90 Postpartum
Time frame: At Day 31 (post-vaccination), Delivery, Days 42 and 90 (postpartum)
Geometric Mean Ratio relative to pre-vaccination (Day 1) of serotype-specific (Ib) GBS serum IgG antibody concentrations (anti-Ib) in maternal subjects. As the singleton ELISA was no longer in use at the time of serotypes Ib and III testing, results for both serotypes were tested using multiplex immunoassay.
Ratio Relative to Pre-vaccination Levels of Maternal Serum GBS IgG Antibody Levels - Serotype III, as Measured at Study Day 31, at Delivery and at Days 42 and 90 Postpartum
Time frame: At Day 31 (post-vaccination), Delivery, Days 42 and 90 (postpartum)
Geometric Mean Ratio relative to pre-vaccination (Day 1) of serotype-specific (III) GBS serum IgG antibody concentrations (anti-III) in maternal subjects. As the singleton ELISA was no longer in use at the time of serotypes Ib and III testing, results for both serotypes were tested using multiplex immunoassay.
19 secondary outcomes
Ratio of GBS IgG Antibody Levels - Serotype Ia in Infant Serum Relative to Maternal Serum at the Time of Delivery
Time frame: At Delivery
Ratio of GBS IgG Antibody Levels - Serotype Ib in Infant Serum Relative to Maternal Serum at the Time of Delivery
Time frame: At Delivery
Ratio of GBS IgG Antibody Levels - Serotype III in Infant Serum Relative to Maternal Serum at the Time of Delivery
Time frame: At Delivery
Percentage of Maternal Subjects With Solicited Local and Solicited Systemic Adverse Events (AEs) up to 30 Minutes
Time frame: Up to 30 minutes post-vaccination
Percentage of Maternal Subjects With Solicited Local and Solicited Systemic AEs - Study Days 1-3
Time frame: During Study Days 1-3 (from 6 hours through Day 3 post-vaccination)
Percentage of Maternal Subjects With Solicited Local and Solicited Systemic AEs - Study Days 4-7
Time frame: During Study Days 4-7
Percentage of Maternal Subjects With Solicited Local and Solicited Systemic AEs - Study Days 1-7
Time frame: During Study Days 1-7 (from 6 hours through Day 7 post-vaccination)
Percentage of Maternal Subjects With Any Unsolicited AEs
Time frame: From Study Day 1 through Study Day 31
Percentage of Maternal Subjects With Serious Adverse Events (SAEs), Unsolicited Medically Attended AEs (MAEs) and Unsolicited AEs Leading to Study Withdrawal (AEs Lead. Wthwal)
Time frame: From Study Day 1 through Study Day 31
Percentage of Maternal Subjects With SAEs, Unsolicited MAEs and Unsolicited AEs Leading to Study Withdrawal (AEs Lead. Wthwal)
Time frame: From Study Day 32 through Day 180 postpartum
Percentage of Infants With SAEs, Unsolicited MAEs and AEs Leading to Study Withdrawal
Time frame: From Birth through Day 180 of age
Birth Weight of Infants (Mean-Standard Deviation)
Time frame: At Birth
Birth Weight of Infants (Median, Minimum and Maximum)
Time frame: At Birth
Birth Length and Head Circumference of Infants (Mean - Standard Deviation)
Time frame: At Birth
Birth Length and Head Circumference of Infants (Median - Minimum and Maximum)
Time frame: At birth
Infants Apgar Scores (Mean - Standard Deviation)
Time frame: At 1, 5 and 10 minutes
Infants Apgar Scores (Median, Minimum and Maximum)
Time frame: At 1, 5 and 10 minutes
Descriptive Statistics for the Score for the Long-term Developmental Outcome Assessed by Bayley Scales of Infant and Toddler Development 3rd Edition Screening Test (PsychCorp) in Infants (Mean - Standard Deviation)
Time frame: At Day 180 of age
Descriptive Statistics for the Score for the Long-term Developmental Outcome Assessed by Bayley Scales of Infant and Toddler Development 3rd Edition Screening Test (PsychCorp) in Infants (Median, Minimum and Maximum)
Time frame: At Day 180 of age
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32883555Swamy GK, Metz TD, Edwards KM, Soper DE, Beigi RH, Campbell JD, Grassano L, Buffi G, Dreisbach A, Margarit I, Karsten A, Henry O, Lattanzi M, Bebia Z. Safety and immunogenicity of an investigational maternal trivalent group B streptococcus vaccine in pregnant women and their infants: Results from a randomized placebo-controlled phase II trial. Vaccine. 2020 Oct 14;38(44):6930-6940. doi: 10.1016/j.vaccine.2020.08.056. Epub 2020 Sep 1.
- Individual participant dataSharing planned: Yes. IPD for this study is available via the Clinical Study Data Request site.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GBS trivalent vaccine in people with GBS Disease and Streptococcus Agalactiae, run by GlaxoSmithKline at 6 sites in United States.
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 5 inclusion and 20 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 29 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. 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. 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 30 May 2017). 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?
Concentration of Serotype Ia GBS IgG Levels in Infant Serum at Delivery and at Days 42 and 90 of Age (time frame: At Birth, Day 42 and Day 90). The study lists 9 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 NCT02046148, which also lists 1 linked publication.
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 29 Dec 2020.