Meningococcal VaccinePhase 3NCT04440163
MenABCWY Noninferiority Study in Healthy Participants ≥10 to <26 Years of Age
A Phase 3 study testing MenABCWY, Saline and Trumenba in people with Meningococcal Vaccine, run by Pfizer at 78 sites in 5 countries.
Trial summary
The aim of this study is to determine the immunologic noninferiority of MenABCWY to licensed vaccines Trumenba and MenACWY-CRM (Menveo) by assessing the safety and immunogenicity of MenABCWY and the comparators in both ACWY-naïve and ACWY-experienced healthy participants ≥10 to <26 years of age. Read more about this study
- Who is it for?
- Ages 10 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Meningococcal Vaccine
- What is being tested?
- MenABCWY, Saline and Trumenba
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,431 participants
- Where
- 78 sitesin 5 countries
- Study dates
- 17 Jun 2020to 24 Jul 2022
- Phase
- Phase 3
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 10 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Male or female subject aged >=10 and <26 years at the time of randomization.
- Healthy subject as determined by medical history, physical examination, and judgment of the investigator.
- Negative urine pregnancy test for all female subjects.
- ACWY-naïve participants: Participants who have never received a prior dose of a meningococcal vaccine containing ACWY serogroups.
- ACWY-experienced participants: Participants who have received not more than 1 prior dose, no sooner than 4 years prior to the date of randomization of Menactra or Menveo.
Who cannot join
- Previous vaccination with any meningococcal group B vaccine, any purely polysaccharide (nonconjugate) meningococcal vaccine, or monovalent/bivalent meningococcal vaccine.- Subjects receiving any allergen immunotherapy with a non-licensed product or receiving allergen immunotherapy with a licensed product and are not on stable maintenance doses.
- A known or suspected defect of the immune system that would prevent an immune response to the vaccine, such as subjects with congenital or acquired defects in B cell function, those receiving chronic systemic (oral, intravenous, or intramuscular) corticosteroid therapy, or those receiving immunosuppressive therapy. Subjects in the United States with terminal complement deficiency are excluded from participation in this study.
- Significant neurological disorder or history of seizure (excluding simple febrile seizure).
- Current chronic use of systemic antibiotics.
- Participation in other studies involving investigational drug(s) or investigational vaccine(s) within 28 days prior to study entry and/or during study participation.
- Any neuroinflammatory or autoimmune condition, including, but not limited to, transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.
- History of microbiologically proven disease caused by N meningitidis or Neisseria gonorrhoeae.
- Receipt of any blood products, including immunoglobulin, within 6 months before the first study vaccination.
Trial locations and contacts
78 sites in 5 countries.
78 sites in 5 countries
United States61 sites
The Iowa Clinic
Ankeny, Iowa, 50023
Velocity Clinical Research (Banning)
Banning, California, 92220
Meridian Clinical Research, LLC
Baton Rouge, Louisiana, 70806
Meridian Clinical Research, LLC
Baton Rouge, Louisiana, 70809
Meridian Clinical Research, LLC
Binghamton, New York, 13901
Alabama Clinical Therapeutics, LLC, Birmington Pediatric Assocaites
Birmingham, Alabama, 35205
Central Research Associates, Inc.
Birmingham, Alabama, 35205
Internal Medicine and Pediatric Associates of Bristol, PC
Bristol, Tennessee, 37620
Family Medicine Associates of Texas
Carrollton, Texas, 75010
Tekton Research, Inc.
Chamblee, Georgia, 30341
Velocity Clinical Research - Cleveland
Cleveland, Ohio, 44122
Optumcare Colorado Springs, LLC
Colorado Springs, Colorado, 80922
ALL Medical Research, LLC
Cooper City, Florida, 33024
Alliance for MultiSpecialty Research, LLC - Miami
Coral Gables, Florida, 33134
Dayton Clinical Research
Dayton, Ohio, 45409
Alliance for Multispecialty Research, LLC
El Dorado, Kansas, 67042
Skyline Medical Center, PC/CCT Research
Elkhorn, Nebraska, 68022
Liberty Family Practice
Erie, Pennsylvania, 16508
Pediatric Associates of Fairfield, Inc.
Fairfield, Ohio, 45014
Acorn to Oak Pediatrics - ACC Pediatric Research
Haughton, Louisiana, 71037
Olympus Family Medicine/CCT Research
Holladay, Utah, 84117
Health Awareness, Inc.
Jupiter, Florida, 33458
Holston Medical Group
Kingsport, Tennessee, 37660
Altus Research
Lake Worth, Florida, 33461
Michael W. Simon, MD, PSC
Lexington, Kentucky, 40517
Madera Family Medical Group
Madera, California, 93637
Velocity Clinical Research - Boise
Meridian, Idaho, 83642
Acevedo Clinical Research Associates
Miami, Florida, 33142
Healthy Life Research, Inc.
Miami, Florida, 33175
Bio-Medical Research, LLC
Miami, Florida, 33184
Crystal Biomedical Research, LLC
Miami Lakes, Florida, 33014
San Marcus Research Clinic, Inc.
Miami Lakes, Florida, 33014
MOC Research
Mishawaka, Indiana, 46544
Accellacare US Inc.
Mt. Pleasant, South Carolina, 29464
Saltzer Health
Nampa, Idaho, 83686
Alliance for Multispecialty Research, LLC
Newton, Kansas, 67114
Lynn Institute of Norman
Norman, Oklahoma, 73072
Quality Clinical Research
Omaha, Nebraska, 68114
Complete Health Research
Ormond Beach, Florida, 32174
Oviedo Medical Research, LLC
Oviedo, Florida, 32765
Center for Clinical Trials, LLC
Paramount, California, 90723
Center for Clinical Trials
Paramount, California, 90723
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
AIM Trials, LLC
Plano, Texas, 75093
North Texas Family Medicine
Plano, Texas, 75093
Pediatric Care
Provo, Utah, 84604
PMG Research of Salisbury, LLC
Salisbury, North Carolina, 28144
J. Lewis Research, Inc. / Foothill Family Clinic
Salt Lake City, Utah, 84109
J. Lewis Research, Inc. / Foothill Family Clinic South
Salt Lake City, Utah, 84121
Tekton Research
San Antonio, Texas, 78229
The South Bend Clinic Center for Research
South Bend, Indiana, 46617
Senders Pediatrics
South Euclid, Ohio, 44121
J. Lewis Research, Inc. / Jordan River Family Medicine
South Jordan, Utah, 84095
Sundance Clinical Research, LLC
St Louis, Missouri, 63141
PAS Research
Tampa, Florida, 33613
Fiel Family and Sports Medicine, PC/CCT Research
Tempe, Arizona, 85283
The Iowa Clinic
West Des Moines, Iowa, 50266
PMG Research of Wilmington, LLC
Wilmington, North Carolina, 28401
Accellacare - Winston-Salem
Winston-Salem, North Carolina, 27103
PMG Research of Winston-Salem, LLC
Winston-Salem, North Carolina, 27103
Tekton Research
Yukon, Oklahoma, 73099
Czechia6 sites
SANARE s.r.o
České Budějovice, 37006
Fakultni nemocnice Hradec Kralove
Hradec Králové, 50005
Ordinace praktickeho lekare pro deti a dorost
Jindřichův Hradec, 377 01
MUDr. Katerina Stichhauerova s.r.o.
Pardubice, 530 03
Medicentrum 6 s.r.o.
Prague, 160 00
Praktik Pb s.r.o.
Příbram, 26101
Hungary5 sites
DRC Gyógyszervizsgáló Központ Kft.
Balatonfüred, 8230
ClinTrial Audit Kft., Klinikai Farmakologiai Intezet, Vedooltasi Ambulancia
Debrecen, 4031
Coronella Orvosi Centrum / Trial Pharma Kft.
Gyula, 5700
CRU Hungary Kft.
Miskolc, 3529
Fejér Megyei Szent György Egyetemi Oktató Kórház
Székesfehérvár, 8000
Poland5 sites
Centrum Badan Klinicznych JCI
Krakow, 30-348
Przylądek Zdrowia
Krakow, 30-644
Niepubliczny Zaklad Opieki Zdrowotnej "Salmed"
Łęczna, 21-010
Niepubliczny Zaklad Lecznictwa Ambulatoryjnego MICHALKOWICE
Siemianowice Śląskie, 41-103
Szpital im. Sw. Jadwigi Slaskiej w Trzebnicy
Trzebnica, 55-100
About this study
Official title: A PHASE 3, RANDOMIZED, ACTIVE-CONTROLLED, OBSERVER-BLINDED TRIAL TO ASSESS THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF MenABCWY IN HEALTHY PARTICIPANTS ≥10 TO <26 YEARS OF AGE
The aim of this study is to determine the immunologic noninferiority of MenABCWY to licensed vaccines Trumenba and MenACWY-CRM (Menveo) by assessing the safety and immunogenicity of MenABCWY and the comparators in both ACWY-naïve and ACWY-experienced healthy participants ≥10 to <26 years of age.
- Conditions
- Meningococcal Vaccine
- Being tested
- MenABCWY, Saline, Trumenba, MenACWY-CRM
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MenABCWYBiological
N meningitidis groups A, B, C, W, and Y vaccine
SalineBiological
Placebo
TrumenbaBiological
Bivalent recombinant lipoprotein 2086 vaccine
MenACWY-CRMBiological
Meningococcal group A, C, W-135, and Y conjugate vaccine
| Study group | Role | What they receive |
|---|---|---|
| 1-Immuno Subset (ACWY Naive,MenABCWY/Saline) | Experimental | ACWY Naive subjects, MenABCWY/Saline Receives: Biological: MenABCWY; Biological: Saline |
| 2-Immuno Subset (ACWY Naive, Trumenba/MenACWY-CRM) | Experimental | ACWY Naive subjects, Trumenba/MenACWY-CRM Receives: Biological: Trumenba; Biological: MenACWY-CRM |
| 3-Immuno Subset (ACWY Experienced,MenABCWY/Saline) | Experimental | ACWY Experienced subjects, MenABCWY/Saline Receives: Biological: MenABCWY; Biological: Saline |
| 4-Immuno Subset (ACWY Experienced,Trumenba/MenACWY-CRM) | Experimental | ACWY Experienced subjects, Trumenba/MenACWY-CRM Receives: Biological: Trumenba; Biological: MenACWY-CRM |
| 5-Safety Subset (ACWY Naive,MenABCWY/Saline) | Experimental | ACWY Naive subjects, MenABCWY/Saline Receives: Biological: MenABCWY; Biological: Saline |
| 6-Safety Subset (ACWY Naive,Trumenba/MenACWY-CRM) | Experimental | ACWY Naive subjects, Trumenba/MenACWY-CRM Receives: Biological: Trumenba; Biological: MenACWY-CRM |
| 7-Safety Subset (ACWY Experienced,MenABCWY/Saline) | Experimental | ACWY Experienced subjects, MenABCWY/Saline Receives: Biological: MenABCWY; Biological: Saline |
| 8-Safety Subset (ACWY Experienced,Trumenba/MenACWY-CRM) | Experimental | ACWY Experienced subjects, Trumenba/MenACWY-CRM Receives: Biological: Trumenba; Biological: MenACWY-CRM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Achieving At Least 4-Fold Rise in Serum Bactericidal Assay Using Human Complement (hSBA) Titer From Baseline for Each MenACWY Strains: 1 Month After Vaccination 2 in Group 1 Compared to 1 Month After Vaccination 1 in Group 2
4-fold increase was defined as: 1) for participants with baseline hSBA titer below limit of detection (LOD) (or hSBA titer less than [<] 1:4), 4-fold rise was defined as hSBA titer greater than or equal to (>=) 1:16; 2) baseline hSBA titer >=LOD and < lower limit of quantitation (LLOQ) (i.e. hSBA titer of 1:8), 4-fold rise was defined as hSBA titer >=4 times LLOQ; 3) baseline hSBA titer >=LLOQ, 4-fold rise was defined as hSBA titer >=4 times baseline titer. Exact 2-sided confidence interval (CI) using Clopper and Pearson method was presented. Analysis was performed on post-vaccination (PV) 1 evaluable immunogenicity population (EIP) for Group 2 and PV2 evaluable immunogenicity population for Group 1. Here, 'Overall Number of Participants Analyzed' represented as 'N' and 'Number Analyzed' represented as 'n'.
Measured: Baseline (pre-vaccination on Day 1), 1 month after Vaccination 2 in Group 1 and 1 month after Vaccination 1 in Group 2
Percentage of Participants Achieving At Least 4-Fold Rise in hSBA Titer From Baseline for Each of the MenACWY Strains: 1 Month After Vaccination 2 in Group 3 Compared to 1 Month After Vaccination 1 in Group 4
4-fold increase was defined as: 1) for participants with baseline hSBA titer below LOD (or hSBA titer <1:4), 4-fold rise was defined as hSBA titer >=1:16; 2) baseline hSBA titer >=LOD (i.e., hSBA titer of >=1:4) and < LLOQ (i.e., hSBA titer of 1:8), 4-fold rise was defined as hSBA titer >=4times LLOQ; 3) baseline hSBA titer >=LLOQ, 4-fold rise was defined as hSBA titer >=4 times baseline titer. Exact 2-sided CI using Clopper and Pearson method was presented. Here, 'Overall Number of Participants Analyzed' represented as 'N' and 'Number Analyzed' represented as 'n'.
Measured: Baseline (pre-vaccination on Day 1), 1 month after Vaccination 2 in Group 3 and 1 month after Vaccination 1 in Group 4
Percentage of Participants Achieving hSBA Titer Greater Than or Equal to (>=) LLOQ for All Primary Neisseria Meningitidis Group B (MenB) Test Strains Combined (Composite Response): Groups 1 and 3 Combined Versus Groups 2 and 4 Combined
Percentage of participants achieving hSBA titer >= LLOQ (1:16 for strain A22 and 1:8 for strains A56, B24, and B44) for all MenB test strains (A22, A56, B24 and B44) combined were reported in this outcome measure. Exact 2-sided CI using the Clopper and Pearson method was presented.
Measured: 1 month after Vaccination 2
Percentage of Participants Achieving At Least a 4-Fold Rise in hSBA Titer From Baseline For Each Primary MenB Test Strains at 1 Month After Vaccination 2: Groups 1 and 3 Combined Versus Groups 2 and 4 Combined
Percentage of participants achieving at least a 4-fold rise in hSBA titer for each primary MenB test strains (A22, A56, B24 and B44) were reported in this outcome measure. Exact 2-sided CI using the Clopper and Pearson method was presented.
Measured: Baseline (pre-vaccination on Day 1), 1 month after Vaccination 2
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
Local reactions included pain at injection site, redness and swelling and were recorded by participants in an electronic diary (e-diary). Redness and swelling were measured and recorded in caliper units. 1 caliper unit =0.5 centimeter (cm) and graded as mild: >2.0 to 5.0 cm, moderate: >5.0 to 10.0 cm and severe: >10.0 cm. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity and severe: prevented daily activity. Percentage of participants with local reactions at injection site were reported in this outcome measure. Exact 2-sided CI was based on the Clopper and Pearson method.
Measured: Within 7 days after Vaccination 1
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
Local reactions included pain at injection site, redness and swelling and were recorded by participants in an e-diary. Redness and swelling were measured and recorded in caliper units. 1 caliper unit =0.5 cm and graded as mild: >2.0 to 5.0 cm, moderate: >5.0 to 10.0 cm and severe: >10.0 cm. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity and severe: prevented daily activity. Percentage of participants with local reactions at injection site were reported in this outcome measure. Exact 2-sided CI was based on the Clopper and Pearson method.
Measured: Within 7 days after Vaccination 2
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
Systemic events were recorded by participants in e-diary. Fever was defined as temperature >=38.0 degrees (deg) Celsius (C) and was categorized as 38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Fatigue, headache, chills, muscle pain and joint pain were graded as mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity. Vomiting was graded as mild: 1 to 2 times in 24 hours(h), moderate: >2 times in 24h and severe: required intravenous hydration. Diarrhea was graded as mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h and severe: 6 or more loose stools in 24h. Exact 2-sided CI was based on the Clopper and Pearson method.
Measured: Within 7 days after Vaccination 1
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
Systemic events were recorded by participants in e-diary. Fever was defined as temperature >=38.0 deg C and was categorized as 38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Fatigue, headache, chills, muscle pain and joint pain were graded as mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity. Vomiting was graded as mild: 1 to 2 times in 24h, moderate: >2 times in 24h and severe: required intravenous hydration. Diarrhea was graded as mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h and severe: 6 or more loose stools in 24h. Exact 2-sided CI was based on the Clopper and Pearson method.
Measured: Within 7 days after Vaccination 2
Percentage of Participants With Use of Antipyretic Medication Within 7 Days After Vaccination 1: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
The use of antipyretic medication was recorded by participants in an e-diary for 7 days after vaccination. Exact 2-sided CI was based on the Clopper and Pearson method.
Measured: Within 7 days after Vaccination 1
Percentage of Participants With Use of Antipyretic Medication Within 7 Days After Vaccination 2: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
The use of antipyretic medication recorded by participants in an e-diary for 7 days after vaccination. Exact 2-sided CI was based on the Clopper and Pearson method.
Measured: Within 7 days after Vaccination 2
Percentage of Participants With Adverse Events (AEs) Within 30 Days After Vaccination 1: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. Exact 2-sided CI was based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.
Measured: Within 30 days after Vaccination 1
Percentage of Participants With AEs Within 30 Days After Vaccination 2: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. Exact 2-sided CI was based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.
Measured: Within 30 days after Vaccination 2
Percentage of Participants With AEs Within 30 Days After Any Vaccination: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. Exact 2-sided CI was based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.
Measured: Within 30 days after any vaccination
Percentage of Participants With AEs During Vaccination Phase: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. Exact 2-sided CI was based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.
Measured: From day of Vaccination 1 (Day 1) up to 1 month after Vaccination 2 (approximately 7 months)
Percentage of Participants With Serious Adverse Events (SAEs) Within 30 Days After Vaccination 1: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. Exact 2-sided CI was based on the Clopper and Pearson method.
Measured: Within 30 days after Vaccination 1
Percentage of Participants With SAEs Within 30 Days After Vaccination 2: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. Exact 2-sided CI was based on the Clopper and Pearson method.
Measured: Within 30 days after Vaccination 2
Percentage of Participants With SAEs Within 30 Days After Any Vaccination: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/ incapacity; congenital anomaly/birth defect and other important medical events. Exact 2-sided CI was based on the Clopper and Pearson method.
Measured: Within 30 days after any vaccination
Percentage of Participants With SAEs During Vaccination Phase: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/ incapacity; congenital anomaly/birth defect and other important medical events. Exact 2-sided CI was based on the Clopper and Pearson method.
Measured: From day of Vaccination 1 (Day 1) up to 1 month after Vaccination 2 (approximately 7 months)
Percentage of Participants With SAEs During Follow-up Phase: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/ incapacity; congenital anomaly/birth defect and other important medical events. Exact 2-sided CI was based on the Clopper and Pearson method.
Measured: From 1 month after Vaccination 2 up to 6 months after Vaccination 2 (approximately 5 months)
Percentage of Participants With SAEs Throughout the Study: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/ incapacity; congenital anomaly/birth defect and other important medical events. Exact 2-sided CI was based on the Clopper and Pearson method.
Measured: From day of Vaccination 1 (Day 1) up to 6 months after Vaccination 2 (approximately 12 months)
Percentage of Participants With Medically Attended Adverse Events (MAEs) Within 30 Days After Vaccination 1: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. Exact 2-sided CI was based on the Clopper and Pearson method.
Measured: Within 30 days after Vaccination 1
Percentage of Participants With MAEs Within 30 Days After Vaccination 2: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. Exact 2-sided CI was based on the Clopper and Pearson method.
Measured: Within 30 days after Vaccination 2
Percentage of Participants With MAEs Within 30 Days After Any Vaccination: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. Exact 2-sided CI was based on the Clopper and Pearson method.
Measured: Within 30 days after any vaccination
Percentage of Participants With MAEs During Vaccination Phase: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. Exact 2-sided CI was based on the Clopper and Pearson method.
Measured: From day of Vaccination 1 (Day 1) up to 1 month after Vaccination 2 (approximately 7 months)
Percentage of Participants With MAEs During Follow-up Phase: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. Exact 2-sided CI was based on the Clopper and Pearson method.
Measured: From 1 month after Vaccination 2 up to 6 months after Vaccination 2 (approximately 5 months)
Percentage of Participants With MAEs Throughout the Study: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. Exact 2-sided CI was based on the Clopper and Pearson method.
Measured: From day of Vaccination 1 (Day 1) up to 6 months after Vaccination 2 (approximately 12 months)
Percentage of Participants With Newly Diagnosed Chronic Medical Condition (NDCMC) Within 30 Days After Vaccination 1: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
An NDCMC was defined as a disease or medical condition, not previously identified, that is expected to be persistent or otherwise long-lasting in its effects. Exact 2-sided CI was based on the Clopper and Pearson method.
Measured: Within 30 days after Vaccination 1
Percentage of Participants With NDCMC Within 30 Days After Vaccination 2: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
An NDCMC was defined as a disease or medical condition, not previously identified, that is expected to be persistent or otherwise long-lasting in its effects. Exact 2-sided CI was based on the Clopper and Pearson method.
Measured: Within 30 days after Vaccination 2
Percentage of Participants With NDCMC Within 30 Days After Any Vaccination: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
An NDCMC was defined as a disease or medical condition, not previously identified, that is expected to be persistent or otherwise long-lasting in its effects. Exact 2-sided CI was based on the Clopper and Pearson method.
Measured: Within 30 Days after any vaccination
Percentage of Participants With NDCMC During Vaccination Phase: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
An NDCMC was defined as a disease or medical condition, not previously identified, that is expected to be persistent or otherwise long-lasting in its effects. Exact 2-sided CI was based on the Clopper and Pearson method.
Measured: From day of Vaccination 1 (Day 1) up to 1 month after Vaccination 2 (approximately 7 months)
Percentage of Participants With NDCMC During Follow-up Phase: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
An NDCMC was defined as a disease or medical condition, not previously identified, that is expected to be persistent or otherwise long-lasting in its effects. Exact 2-sided CI was based on the Clopper and Pearson method.
Measured: From 1 month after Vaccination 2 up to 6 months after Vaccination 2 (approximately 5 months)
Percentage of Participants With NDCMC Throughout the Study: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
An NDCMC was defined as a disease or medical condition, not previously identified, that is expected to be persistent or otherwise long-lasting in its effects. Exact 2-sided CI was based on the Clopper and Pearson method.
Measured: From day of Vaccination 1 (Day 1) up to 6 months after Vaccination 2 (approximately 12 months)
Percentage of Participants With Immediate AE Within 30 Minutes After Vaccination 1: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
Immediate AEs were defined as AEs occurring within the first 30 minutes after investigational product administration. Exact 2-sided CI was based on the Clopper and Pearson method.
Measured: Within 30 minutes after Vaccination 1
Percentage of Participants With Immediate AE Within 30 Minutes After Vaccination 2: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
Immediate AEs were defined as AEs occurring within the first 30 minutes after investigational product administration. Exact 2-sided CI was based on the Clopper and Pearson method.
Measured: Within 30 minutes after Vaccination 2
Percentage of Participants Who Missed Days of School or Work Due to AEs During Vaccination Phase: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. Percentage of participants who missed days of school or work due to AEs during vaccination phase were reported in this outcome measure.
Measured: From day of Vaccination 1 (Day 1) up to 1 month after Vaccination 2 (approximately 7 months)
Secondary outcomes (2)
Percentage of Participants Achieving At Least 4-Fold Rise in hSBA Titer From Baseline for Each MenACWY Test Strains: 1 Month After Vaccination 1 in Group 1 Compared to Group 2
4-fold increase was defined as: 1) for participants with baseline hSBA titer below LOD (or hSBA titer <1:4), 4-fold rise was defined as hSBA titer >=1:16; 2) baseline hSBA titer >=LOD (i.e., hSBA titer of >=1:4) and < LLOQ (i.e. hSBA titer of 1:8), 4-fold rise was defined as hSBA titer >=4times LLOQ; 3) baseline hSBA titer >=LLOQ, 4-fold rise was defined as hSBA titer >=4 times baseline titer. Exact 2-sided CI using Clopper and Pearson method was presented.
Measured: Baseline (pre-vaccination on Day 1), 1 month after Vaccination 1
Percentage of Participants Achieving At Least 4-Fold Rise in hSBA Titer From Baseline for Each MenACWY Test Strains: 1 Month After Vaccination 1 in Group 3 Compared to Group 4
4-fold increase was defined as: 1) for participants with baseline hSBA titer below LOD (or hSBA titer <1:4), 4-fold rise was defined as hSBA titer >=1:16; 2) baseline hSBA titer >=LOD (i.e., hSBA titer of >=1:4) and < LLOQ (i.e. hSBA titer of 1:8), 4-fold rise was defined as hSBA titer >=4 times LLOQ; 3) baseline hSBA titer > =LLOQ, 4-fold rise was defined as hSBA titer >=4 times baseline titer. Exact 2-sided CI using Clopper and Pearson method was presented.
Measured: Baseline (pre-vaccination on Day 1), 1 month after Vaccination 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2020
- Study start17 Jun 2020
- Primary completion24 Jul 2022
- Study completion24 Jul 2022
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 Meningococcal VaccineStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2,431 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
- NCT04440163
- Sponsor's protocol ID
- C3511001
- Other IDs
- 2019-004313-13, 2019
- Status last verified
- Mar 2023
- First submitted
- 15 Jun 2020
- Last updated
- 18 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- 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
Ostergaard L, Czajka H, Roque-Guerrero L, Maguire JD, Pregaldien JL, Zolotas L, Moughan B, Maansson R, O'Neil R, Balmer P, Jodar L, Gruber WC, Anderson AS, Scott DA, Beeslaar J. Immunogenicity and safety of a pentavalent meningococcal MenABCWY vaccine in healthy adolescents and young adults: a phase 3, multicountry, randomised, observer-blinded, active-controlled non-inferiority trial. Lancet Child Adolesc Health. 2026 Aug;10(8):584-596. doi: 10.1016/S2352-4642(26)00095-7. Epub 2026 Jun 18.
PubMed 42314722