MenABCWY Noninferiority Study in Healthy Participants ≥10 to <26 Years of Age

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.

Study Overview

• Status: Completed
• Conditions: Meningococcal Vaccine
• Intervention / Treatment: Biological: Saline; Biological: MenABCWY; Biological: Trumenba; Biological: MenACWY-CRM

• Study Type: Interventional
• Enrollment (Actual): 2431
• Phase: Phase 3

Contacts and Locations

Study Locations

• Czechia
  • Ceske Budejovice, Czechia, 37006
    • SANARE s.r.o
  • Hradec Kralove, Czechia, 50005
    • Fakultni nemocnice Hradec Kralove
  • Jindrichuv Hradec, Czechia, 377 01
    • Ordinace praktického lékaře pro děti a dorost
  • Pardubice, Czechia, 530 03
    • MUDr. Katerina Stichhauerova s.r.o.
  • Praha 6, Czechia, 160 00
    • Medicentrum 6 s.r.o.
  • Pribram, Czechia, 26101
    • Praktik Pb s.r.o.
• Denmark
  • Aarhus N, Denmark, 8200
    • Aarhus Universitetshospital
• Hungary
  • Balatonfüred, Hungary, 8230
    • DRC Gyogyszervizsgalo Kozpont Kft.
  • Debrecen, Hungary, 4031
    • ClinTrial Audit Kft., Klinikai Farmakologiai Intezet, Vedooltasi Ambulancia
  • Gyula, Hungary, 5700
    • Coronella Orvosi Centrum / Trial Pharma Kft.
  • Miskolc, Hungary, 3529
    • CRU Hungary Kft.
  • Székesfehérvár, Hungary, 8000
    • Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
• Poland
  • Krakow, Poland, 30-348
    • Centrum Badan Klinicznych JCI
  • Krakow, Poland, 30-644
    • Przylądek Zdrowia
  • Leczna, Poland, 21-010
    • Niepubliczny Zaklad Opieki Zdrowotnej "Salmed"
  • Siemianowice Slaskie, Poland, 41-103
    • Niepubliczny Zaklad Lecznictwa Ambulatoryjnego Michalkowice
  • Trzebnica, Poland, 55-100
    • Szpital im. Św. Jadwigi Śląskiej w Trzebnicy
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • Central Research Associates, Inc.
    • Birmingham, Alabama, United States, 35205
      • Alabama Clinical Therapeutics, LLC, Birmington Pediatric Assocaites
  • Arizona
    • Tempe, Arizona, United States, 85283
      • Fiel Family and Sports Medicine, PC/CCT Research
  • California
    • Banning, California, United States, 92220
      • Velocity Clinical Research (Banning)
    • Madera, California, United States, 93637
      • Madera Family Medical Group
    • Paramount, California, United States, 90723
      • Center for Clinical Trials, LLC
    • Paramount, California, United States, 90723
      • Center for Clinical Trials
  • Colorado
    • Colorado Springs, Colorado, United States, 80922
      • Optumcare Colorado Springs, LLC
  • Florida
    • Cooper City, Florida, United States, 33024
      • ALL Medical Research, LLC
    • Coral Gables, Florida, United States, 33134
      • Alliance for MultiSpecialty Research, LLC - Miami
    • Jupiter, Florida, United States, 33458
      • Health Awareness, Inc.
    • Lake Worth, Florida, United States, 33461
      • Altus Research
    • Miami, Florida, United States, 33184
      • Bio-Medical Research, LLC
    • Miami, Florida, United States, 33142
      • Acevedo Clinical Research Associates
    • Miami, Florida, United States, 33175
      • Healthy Life Research, Inc.
    • Miami Lakes, Florida, United States, 33014
      • San Marcus Research Clinic, Inc.
    • Miami Lakes, Florida, United States, 33014
      • Crystal Biomedical Research, LLC
    • Ormond Beach, Florida, United States, 32174
      • Complete Health Research
    • Oviedo, Florida, United States, 32765
      • Oviedo Medical Research, LLC
    • Tampa, Florida, United States, 33613
      • Pas Research
  • Georgia
    • Chamblee, Georgia, United States, 30341
      • Tekton Research, Inc.
  • Idaho
    • Meridian, Idaho, United States, 83642
      • Velocity Clinical Research - Boise
    • Nampa, Idaho, United States, 83686
      • Saltzer Health
  • Indiana
    • Mishawaka, Indiana, United States, 46544
      • MOC Research
    • South Bend, Indiana, United States, 46617
      • The South Bend Clinic Center for Research
  • Iowa
    • Ankeny, Iowa, United States, 50023
      • The Iowa Clinic
    • West Des Moines, Iowa, United States, 50266
      • The Iowa Clinic
  • Kansas
    • El Dorado, Kansas, United States, 67042
      • Alliance for Multispecialty Research, LLC
    • Newton, Kansas, United States, 67114
      • Alliance for Multispecialty Research, LLC
  • Kentucky
    • Lexington, Kentucky, United States, 40517
      • Michael W. Simon, MD, PSC
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70809
      • Meridian Clinical Research, LLC
    • Baton Rouge, Louisiana, United States, 70806
      • Meridian Clinical Research, LLC
    • Haughton, Louisiana, United States, 71037
      • Acorn to Oak Pediatrics - ACC Pediatric Research
  • Missouri
    • Saint Louis, Missouri, United States, 63141
      • Sundance Clinical Research, LLC
  • Nebraska
    • Elkhorn, Nebraska, United States, 68022
      • Skyline Medical Center, PC/CCT Research
    • Omaha, Nebraska, United States, 68114
      • Quality Clinical Research
  • New York
    • Binghamton, New York, United States, 13901
      • Meridian Clinical Research, LLC
  • North Carolina
    • Salisbury, North Carolina, United States, 28144
      • PMG Research of Salisbury, LLC
    • Wilmington, North Carolina, United States, 28401
      • PMG Research of Wilmington, LLC
    • Winston-Salem, North Carolina, United States, 27103
      • PMG Research of Winston-Salem, LLC
    • Winston-Salem, North Carolina, United States, 27103
      • Accellacare - Winston-Salem
  • Ohio
    • Cleveland, Ohio, United States, 44122
      • Velocity Clinical Research - Cleveland
    • Dayton, Ohio, United States, 45409
      • Dayton Clinical Research
    • Fairfield, Ohio, United States, 45014
      • Pediatric Associates of Fairfield, Inc.
    • South Euclid, Ohio, United States, 44121
      • Senders Pediatrics
  • Oklahoma
    • Norman, Oklahoma, United States, 73072
      • Lynn Institute of Norman
    • Yukon, Oklahoma, United States, 73099
      • Tekton Research
  • Pennsylvania
    • Erie, Pennsylvania, United States, 16508
      • Liberty Family Practice
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University
  • South Carolina
    • Mount Pleasant, South Carolina, United States, 29464
      • Accellacare US Inc.
  • Tennessee
    • Bristol, Tennessee, United States, 37620
      • Internal Medicine and Pediatric Associates of Bristol, PC
    • Kingsport, Tennessee, United States, 37660
      • Holston Medical Group
  • Texas
    • Carrollton, Texas, United States, 75010
      • Family Medicine Associates of Texas
    • Plano, Texas, United States, 75093
      • North Texas Family Medicine
    • Plano, Texas, United States, 75093
      • AIM Trials, LLC
    • San Antonio, Texas, United States, 78229
      • Tekton Research
  • Utah
    • Holladay, Utah, United States, 84117
      • Olympus Family Medicine/CCT Research
    • Provo, Utah, United States, 84604
      • Pediatric Care
    • Salt Lake City, Utah, United States, 84109
      • J. Lewis Research, Inc. / Foothill Family Clinic
    • Salt Lake City, Utah, United States, 84121
      • J. Lewis Research, Inc. / Foothill Family Clinic South
    • South Jordan, Utah, United States, 84095
      • J. Lewis Research, Inc. / Jordan River Family Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 25 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Quadruple

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1-Immuno Subset (ACWY Naive,MenABCWY/Saline); ACWY Naive subjects, MenABCWY/Saline	Biological: Saline; Placebo; Biological: MenABCWY; N meningitidis groups A, B, C, W, and Y vaccine
Experimental: 2-Immuno Subset (ACWY Naive, Trumenba/MenACWY-CRM); ACWY Naive subjects, Trumenba/MenACWY-CRM	Biological: Trumenba; Bivalent recombinant lipoprotein 2086 vaccine; Biological: MenACWY-CRM; Meningococcal group A, C, W-135, and Y conjugate vaccine
Experimental: 3-Immuno Subset (ACWY Experienced,MenABCWY/Saline); ACWY Experienced subjects, MenABCWY/Saline	Biological: Saline; Placebo; Biological: MenABCWY; N meningitidis groups A, B, C, W, and Y vaccine
Experimental: 4-Immuno Subset (ACWY Experienced,Trumenba/MenACWY-CRM); ACWY Experienced subjects, Trumenba/MenACWY-CRM	Biological: Trumenba; Bivalent recombinant lipoprotein 2086 vaccine; Biological: MenACWY-CRM; Meningococcal group A, C, W-135, and Y conjugate vaccine
Experimental: 5-Safety Subset (ACWY Naive,MenABCWY/Saline); ACWY Naive subjects, MenABCWY/Saline	Biological: Saline; Placebo; Biological: MenABCWY; N meningitidis groups A, B, C, W, and Y vaccine
Experimental: 6-Safety Subset (ACWY Naive,Trumenba/MenACWY-CRM); ACWY Naive subjects, Trumenba/MenACWY-CRM	Biological: Trumenba; Bivalent recombinant lipoprotein 2086 vaccine; Biological: MenACWY-CRM; Meningococcal group A, C, W-135, and Y conjugate vaccine
Experimental: 7-Safety Subset (ACWY Experienced,MenABCWY/Saline); ACWY Experienced subjects, MenABCWY/Saline	Biological: Saline; Placebo; Biological: MenABCWY; N meningitidis groups A, B, C, W, and Y vaccine
Experimental: 8-Safety Subset (ACWY Experienced,Trumenba/MenACWY-CRM); ACWY Experienced subjects, Trumenba/MenACWY-CRM	Biological: Trumenba; Bivalent recombinant lipoprotein 2086 vaccine; Biological: MenACWY-CRM; Meningococcal group A, C, W-135, and Y conjugate vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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'.	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'.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	From day of Vaccination 1 (Day 1) up to 1 month after Vaccination 2 (approximately 7 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Baseline (pre-vaccination on Day 1), 1 month after Vaccination 1

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): June 17, 2020
• Primary Completion (Actual): July 24, 2022
• Study Completion (Actual): July 24, 2022

Study Registration Dates

• First Submitted: June 15, 2020
• First Submitted That Met QC Criteria: June 18, 2020
• First Posted (Actual): June 19, 2020

Study Record Updates

• Last Update Posted (Actual): April 18, 2023
• Last Update Submitted That Met QC Criteria: March 22, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: C3511001; 2019-004313-13 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No