A Trial to Describe the Immunogenicity and Safety of 2 Doses of Bivalent rLP2086 (Trumenba) and a Pentavalent Meningococcal Vaccine in Healthy Subjects >=10 to <26 Years of Age.

A PHASE 3, RANDOMIZED, ACTIVE-CONTROLLED, OBSERVER-BLINDED STUDY TO ASSESS THE IMMUNOGENICITY, SAFETY, AND TOLERABILITY OF BIVALENT RLP2086 WHEN ADMINISTERED AS A 2-DOSE REGIMEN AND A FIRST-IN-HUMAN STUDY TO DESCRIBE THE IMMUNOGENICITY, SAFETY, AND TOLERABILITY OF A BIVALENT RLP2086-CONTAINING PENTAVALENT VACCINE (MENABCWY) IN HEALTHY SUBJECTS>=10 TO <26 YEARS OF AGE

This study is examining safety and immunogenicity of 2 doses of Trumenba administered on a 0-,6- month schedule. This trial is also studying safety and immunogenicity of a meningococcal pentavalent vaccine.

Study Overview

• Status: Completed
• Conditions: Meningococcal Vaccine
• Intervention / Treatment: Biological: MenABCWY; Biological: Saline; Biological: rLP2086; Biological: MenACWY-CRM

• Study Type: Interventional
• Enrollment (Actual): 1610
• Phase: Phase 3

Contacts and Locations

Study Locations

• Czechia
  • Jindrichuv Hradec, Czechia, 377 01
    • Ordinace praktického lékaře pro děti a dorost
  • Praha 6, Czechia, 160 00
    • MEDICENTRUM 6 s.r.o. - Ordinace praktickeho lekare pro deti a dorost
• Finland
  • Espoo, Finland, 02230
    • Espoo Vaccine Research Clinic
  • Helsinki, Finland, 00100
    • Helsinki South Vaccine Research Clinic
  • Helsinki, Finland, 00930
    • Helsinki East Vaccine Research Clinic
  • Järvenpää, Finland, 04400
    • Järvenpää Vaccine Research Clinic
  • Kokkola, Finland, 67100
    • Kokkola Vaccine Research Clinic
  • Oulu, Finland, 90220
    • Oulu Vaccine Research Clinic
  • Pori, Finland, 28100
    • Pori Vaccine Research Clinic
  • Seinajoki, Finland, 60100
    • Seinäjoki Vaccine Research Clinic
  • Tampere, Finland, 33100
    • Tampere Vaccine Research Clinic
  • Turku, Finland, 20520
    • Turku Vaccine Research Clinic
• Poland
  • Debica, Poland, 39-200
    • Jerzy Brzostek Prywatny Gabinet Lekarski
  • Krakow, Poland, 30-348
    • Hanna Czajka Indywidualna Specjalistyczna Praktyka Lekarska
  • Krakow, Poland, 31-202
    • Oddzial Pediatrii i Neurologii Dzieciecej, Krakowski Szpital Specjalistyczny im. Jana Pawla II
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • Alabama Clinical Therapeutics, LLC
    • Huntsville, Alabama, United States, 35802
      • Optimal Research, LLC
  • Arizona
    • Fountain Hills, Arizona, United States, 85268
      • Synexus Clinical Research US, Inc./Fountain Hills Family Practice, P.C.
    • Tempe, Arizona, United States, 85283
      • Clinical Research Consortium
  • Arkansas
    • Harrisburg, Arkansas, United States, 72432
      • Harrisburg Family Medical Center
  • California
    • La Mesa, California, United States, 91942
      • Paradigm Clinical Research Centers, Inc.
    • San Diego, California, United States, 92123
      • California Research Foundation
    • Santa Clara, California, United States, 95051
      • Kaiser Permanente Santa Clara
  • Florida
    • DeLand, Florida, United States, 32720
      • Avail Clinical Research, LLC
    • Jupiter, Florida, United States, 33458
      • Health Awareness, Inc.
    • Melbourne, Florida, United States, 32934
      • Optimal Research, LLC
  • Georgia
    • Savannah, Georgia, United States, 31406
      • Meridian Clinical Research LLC
  • Illinois
    • Peoria, Illinois, United States, 61614
      • Optimal Research
  • Iowa
    • Sioux City, Iowa, United States, 51106
      • Meridian Clinical Research
  • Kansas
    • Newton, Kansas, United States, 67114
      • Alliance for Multispecialty Research, LLC
    • Wichita, Kansas, United States, 67207
      • Alliance for Multispecialty Research, LLC
    • Wichita, Kansas, United States, 67205
      • Heartland Research Associates, LLC
    • Wichita, Kansas, United States, 67207
      • Heartland Research Associates, LLC
    • Wichita, Kansas, United States, 67207
      • Alliance for Multispecialty Research (AMR)
  • Kentucky
    • Bardstown, Kentucky, United States, 40004
      • Kentucky Pediatric/Adult Research
  • Louisiana
    • Eunice, Louisiana, United States, 70535
      • Horizon Research Group of Opelousas, LLC
    • Haughton, Louisiana, United States, 71037
      • ACC Pediatric Research
  • Nebraska
    • Fremont, Nebraska, United States, 68025
      • Methodist Physicians Clinic/CCT Research
    • Norfolk, Nebraska, United States, 68701
      • Meridian Clinical Research, LLC
    • Omaha, Nebraska, United States, 68134
      • Meridian Clinical Research, LLC
  • New York
    • Binghamton, New York, United States, 13901
      • United Medical Associates
    • Binghamton, New York, United States, 13901
      • Meridian Clinical Research, LLC
    • Binghamton, New York, United States, 13905
      • Meridian Clinical Research, LLC
    • Binghamton, New York, United States, 13905
      • United Medical Associates
    • Endwell, New York, United States, 13760
      • Regional Clinical Research, Inc
    • Rochester, New York, United States, 14609
      • Rochester Clinical Research, Inc.
    • Vestal, New York, United States, 13850
      • Meridian Clinical Research, LLC
    • Vestal, New York, United States, 13850
      • Regional Clinical Research, Inc
  • North Carolina
    • Raleigh, North Carolina, United States, 27609
      • Capitol Pediatrics & Adolescent Center PLLC
  • Ohio
    • Cincinnati, Ohio, United States, 45246
      • Meridian Clinical Research, LLC
    • Cleveland, Ohio, United States, 44122
      • Velocity Clinical Research, Inc.
    • Columbus, Ohio, United States, 43213
      • Aventiv Research Inc.
    • Dayton, Ohio, United States, 45414
      • Ohio Pediatric Research Association, Inc.
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Lynn Health Science Institute
  • Pennsylvania
    • Erie, Pennsylvania, United States, 16508
      • Liberty Family Practice
  • South Carolina
    • Charleston, South Carolina, United States, 29403
      • Charleston Pediatrics, PA
    • Mount Pleasant, South Carolina, United States, 29464
      • PMG Research of Charleston, LLC
    • North Charleston, South Carolina, United States, 29405
      • Coastal Carolina Research Center
  • Tennessee
    • Bristol, Tennessee, United States, 37620
      • Internal Medicine and Pediatric Associates of Bristol, PC
    • Bristol, Tennessee, United States, 37620
      • PMG Research of Bristol, LLC
    • Kingsport, Tennessee, United States, 37660
      • Holston Medical Group
    • Nashville, Tennessee, United States, 37203
      • Clinical Research Associates, Inc.
  • Texas
    • Austin, Texas, United States, 78705
      • Benchmark Research
    • Fort Worth, Texas, United States, 76104
      • Ventavia Research Group, LLC
    • Fort Worth, Texas, United States, 76104
      • Texas Health Care, PLLC
    • Fort Worth, Texas, United States, 76135
      • Benchmark Research
    • Plano, Texas, United States, 75024
      • ACRC Trials
    • Plano, Texas, United States, 75093
      • North Texas Family Medicine
    • San Antonio, Texas, United States, 78229
      • Clinical Trials of Texas, Inc.
  • Utah
    • Draper, Utah, United States, 84020
      • J. Lewis Research Inc. / Foothill Family Clinic Draper
    • 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
  • Virginia
    • Burke, Virginia, United States, 22015
      • PI-Coor Clinical Research, LLC
    • Charlottesville, Virginia, United States, 22902
      • Pediatric Research of Charlottesville, LLC

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 enrollment.
• Healthy subject as determined by medical history, physical examination, and judgment of the investigator.
• Negative urine pregnancy test for all female subjects.
• Subjects who have not received, or who have received no more than 1 prior dose within the past 4 years, of a vaccine containing 1 or more ACWY serogroup

Exclusion Criteria:

• Previous vaccination with any meningococcal serogroup B or purely polysaccharide (nonconjugate) meningococcal vaccine.
• Subjects receiving any allergen immunotherapy with a nonlicensed 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.
• Received any investigational vaccines, drugs, or devices within 28 days before administration of the first study vaccination.
• Any neuroinflammatory or autoimmune condition, including, but not limited to, transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1 (ACWY Naive subjects, MenABCWY/Saline); ACWY Naive subjects, MenABCWY/Saline	Biological: MenABCWY; N meningitidis group A, B, C, W, and Y vaccine; Biological: Saline; Placebo
Experimental: Group 2 (ACWY Naive subjects, rLP2086/MenACWY-CRM); ACWY Naive subjects, rLP2086/MenACWY-CRM	Biological: rLP2086; Bivalent recombinant lipoprotein 2086 vaccine; Biological: MenACWY-CRM; meningococcal group A, C, W-135, and Y conjugate vaccine
Experimental: Group 3 (ACWY Experienced subjects, MenABCWY/Saline); ACWY Experienced subjects, MenABCWY/Saline	Biological: MenABCWY; N meningitidis group A, B, C, W, and Y vaccine; Biological: Saline; Placebo
Experimental: Group 4 (ACWY Experienced subjects, rLP2086/MenACWY-CRM); ACWY Experienced subjects, rLP2086/MenACWY-CRM	Biological: rLP2086; 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
Stage1: Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level >= Lower Limit of Quantitation (LLOQ) for All 4 Primary Test Strains Combined 1 Month After Vaccination 2 (Group 2 and 4 Combined)	Percentage of participants who achieved an hSBA titer >= LLOQ for all 4 primary MenB test strains combined (LLOQ was 1:16 for A22 and 1:8 for A56, B24, and B44) was reported in this outcome. Analysis for this outcome measure was planned for combined Group 2 and 4.	1 month after Vaccination 2
Stage1: Percentage of Participants With Fold Rise >=4 in hSBA for Each of the 4 Primary MenB Test Strains From Baseline to 1 Month After Vaccination 2 (Group 2 and 4 Combined)	The 4-fold increase: a) participants with baseline hSBA titer below limit of detection (LOD or an hSBA titer <1:4), response was defined as hSBA titer >=1:16 or LLOQ (whichever titer is higher); b) Participants with baseline hSBA titer >= LOD and < LLOQ, response was defined as hSBA titer >= 4 times the LLOQ; c) participants with baseline hSBA titer >= LLOQ, response was defined as hSBA titer >=4 times baseline titer. Four primary MenB test strains were PMB80 (A22), PMB2001 (A56), PMB2948 (B24) and PMB2707 (B44). Analysis for this outcome measure was planned for combined Group 2 and 4.	From Baseline (blood draw prior to Vaccination 1) to 1 month after Vaccination 2
Stage1: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 (Group 2 and 4 Combined)	Local reactions (redness, swelling, and pain) at the site of investigational product administration were recorded in e-diary. Redness and swelling were measured and recorded in caliper units. Each caliper unit represented 0.5 cm. Redness and swelling were 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 activity), moderate (interfered with activity), and severe (prevented daily activity).	7 days after Vaccination 1
Stage1: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 (Group 2 and 4 Combined)	Local reactions (redness, swelling, and pain) at the site of investigational product administration were recorded in e-diary. Redness and swelling were measured and recorded in caliper units. Each caliper unit represented 0.5 cm. Redness and swelling were 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 activity), moderate (interfered with activity), and severe (prevented daily activity).	7 days after Vaccination 2
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 (Group 2 and 4 Combined)	Systemic events fever, vomiting, diarrhea, headache, fatigue, chills, muscle pain other than muscle pain at the injection site, and joint pain were recorded by using an e-diary. Fever was defined as >=38.0 degree Celsius (C) and categorized to 38.0 to 38.4 degree C, 38.5 to 38.9 degree C, 39.0 to 40.0 degree C and >40.0 degree C. Headache, fatigue, chills, muscle pain and joint pain were graded as mild (did not interfere with activity), moderate (some interference with activity) and severe (prevented daily activity). Vomiting was graded as mild (1-2 times in 24 hours), moderate (>2 times in 24 hours) and severe (required IV hydration). Diarrhea was graded as mild (2-3 loose stools in 24 hours), moderate (4-5 loose stools in 24 hours) and severe (>=6 in 24 hours).	7 days after Vaccination 1
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 (Group 2 and 4 Combined)	Systemic events fever, vomiting, diarrhea, headache, fatigue, chills, muscle pain other than muscle pain at the injection site, and joint pain were recorded by using an e-diary. Fever was defined as >=38.0 degree C and categorized to 38.0 to 38.4 degree C, 38.5 to 38.9 degree C, 39.0 to 40.0 degree C and >40.0 degree C. Headache, fatigue, chills, muscle pain and joint pain were graded as mild (did not interfere with activity), moderate (some interference with activity) and severe (prevented daily activity). Vomiting was graded as mild (1-2 times in 24 hours), moderate (>2 times in 24 hours) and severe (required IV hydration). Diarrhea was graded as mild (2-3 loose stools in 24 hours), moderate (4-5 loose stools in 24 hours) and severe (>=6 in 24 hours).	7 days after Vaccination 2
Stage1: Percentage of Participants With Antipyretic Medication Use Within 7 Days After Vaccination 1 (Group 2 and 4 Combined)		7 days after Vaccination 1
Stage1: Percentage of Participants With Antipyretic Medication Use Within 7 Days After Vaccination 2 (Group 2 and 4 Combined)		7 days after Vaccination 2
Stage1: Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Vaccination 1 (Group 2 and 4 Combined)	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. Or that was considered to be an important medical event.	30 days after Vaccination 1
Stage1: Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Vaccination 2 (Group 2 and 4 Combined)	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. Or that was considered to be an important medical event.	30 days after Vaccination 2
Stage1: Percentage of Participants With at Least 1 SAE Within 30 Days After Any Vaccination (Group 2 and 4 Combined)	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. Or that was considered to be an important medical event.	30 days after any vaccination
Stage1: Percentage of Participants With at Least 1 SAE During the Stage 1 Vaccination Phase (Group 2 and 4 Combined)	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. Or that was considered to be an important medical event.	Stage 1 Vaccination Phase: From Vaccination 1 through 1 month after Vaccination 2 (7 Months)
Stage1: Percentage of Participants With at Least 1 SAE During the Stage 1 Follow-up Phase (Group 2 and 4 Combined)	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. Or that was considered to be an important medical event. There was one participant who did not meet criteria for Stage 1 follow-up safety population. The subject's SAE happened in the follow-up phase but was not included in the follow-up safety population for Stage 1 (but in the safety population for Stage 1). Therefore, the SAE was not included in the follow-up table but in the broadly defined throughout Stage 1 table.	Stage 1 Follow-up phase: From 1 month after Vaccination 2 through 6 months after Vaccination 2 (5 Months)
Stage1: Percentage of Participants With at Least 1 SAE Throughout the Stage 1 (Group 2 and 4 Combined)	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. Or that was considered to be an important medical event. There was one participant who did not meet criteria for Stage 1 follow-up safety population. The subject's SAE happened in the follow-up phase but was not included in the follow-up safety population for Stage 1 (but in the safety population for Stage 1). Therefore, the SAE was not included in the follow-up table but in the broadly defined throughout Stage 1 table.	Throughout Stage 1: From the Vaccination 1 through 6 months after Vaccination 2 (12 Months)
Stage1: Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Vaccination 1 (Group 2 and 4 Combined)	Medically attended AE was defined as a nonserious AE that resulted in an evaluation at a medical facility.	30 days after Vaccination 1
Stage1: Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Vaccination 2 (Group 2 and 4 Combined)	Medically attended AE was defined as a nonserious AE that resulted in an evaluation at a medical facility.	30 days after Vaccination 2
Stage1: Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Any Vaccination (Group 2 and 4 Combined)	Medically attended AE was defined as a nonserious AE that resulted in an evaluation at a medical facility.	30 days after any vaccination
Stage1: Percentage of Participants With at Least 1 Medically Attended AE During the Stage 1 Vaccination Phase (Group 2 and 4 Combined)	Medically attended AE was defined as a nonserious AE that resulted in an evaluation at a medical facility.	Stage 1 Vaccination Phase: From Vaccination 1 through 1 month after Vaccination 2 (7 Months)
Stage1: Percentage of Participants With at Least 1 Medically Attended AE During the Stage 1 Follow-up Phase (Group 2 and 4 Combined)	Medically attended AE was defined as a nonserious AE that resulted in an evaluation at a medical facility.	Stage 1 Follow-up phase: From 1 month after Vaccination 2 through 6 months after Vaccination 2 (5 Months)
Stage1: Percentage of Participants With at Least 1 Medically Attended AE Throughout the Stage 1 (Group 2 and 4 Combined)	Medically attended AE was defined as a nonserious AE that resulted in an evaluation at a medical facility.	Throughout Stage 1: From the Vaccination 1 through 6 months after Vaccination 2 (12 Months)
Stage1: Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition (NDCMC) Within 30 Days After Vaccination 1 (Group 2 and 4 Combined)	A NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.	30 days after Vaccination 1
Stage1: Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition (NDCMC) Within 30 Days After Vaccination 2 (Group 2 and 4 Combined)	A NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.	30 days after Vaccination 2
Stage1: Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition (NDCMC) Within 30 Days After Any Vaccination (Group 2 and 4 Combined)	A NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.	30 days after any Vaccination
Stage1: Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition (NDCMC) During the Stage 1 Vaccination Phase (Group 2 and 4 Combined)	A NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.	Stage 1 Vaccination Phase: From Vaccination 1 through 1 month after Vaccination 2 (7 Months)
Stage1: Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition (NDCMC) During the Stage 1 Follow-up Phase (Group 2 and 4 Combined)	A NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.	Stage 1 Follow-up phase: From 1 month after Vaccination 2 through 6 months after Vaccination 2 (5 Months)
Stage1: Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition (NDCMC) Throughout the Stage 1 (Group 2 and 4)	A NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.	Throughout Stage 1: From the Vaccination 1 through 6 months after Vaccination 2 (12 Months)
Stage1: Percentage of Participants With at Least 1 AE Within 30 Days After Vaccination 1 (Group 2 and 4 Combined)	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs did not include local reaction and systemic events collected by systematic approach.	30 days after Vaccination 1
Stage1: Percentage of Participants With at Least 1 AE Within 30 Days After Vaccination 2 (Group 2 and 4 Combined)	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs did not include local reaction and systemic events collected by systematic approach.	30 days after Vaccination 2
Stage1: Percentage of Participants With at Least 1 AE Within 30 Days After Any Vaccination (Group 2 and 4 Combined)	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs did not include local reaction and systemic events collected by systematic approach.	30 days after any vaccination
Stage1: Percentage of Participants With at Least 1 AE During Vaccination Phase (Group 2 and 4 Combined)	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs did not include local reaction and systemic events collected by systematic approach.	Stage 1 Vaccination Phase: From Vaccination 1 through 1 month after Vaccination 2 (7 Months)
Stage1: Percentage of Participants With at Least 1 Immediate AE After Vaccination 1 (Group 2 and 4 Combined)	Immediate AE was defined as AE occurring within the first 30 minutes after investigational product administration.	30 minutes after Vaccination 1
Stage1: Percentage of Participants With at Least 1 Immediate AE After Vaccination 2 (Group 2 and 4 Combined)	Immediate AE was defined as AE occurring within the first 30 minutes after investigational product administration.	30 minutes after Vaccination 2
Stage1: Number of Participants Who Missed School/Work Due to AE During the Stage 1 Vaccination Phase (Group 2 and 4 Combined)		Stage 1 Vaccination Phase: From Vaccination 1 through 1 month after Vaccination 2 (7 Months)
Stage2: Percentage of Participants With Local Reactions Within 7 Days After Booster Vaccination: Group 1 Through Group 4	Local reactions (redness, swelling, and pain) at the site of investigational product administration were recorded in e-diary. Redness and swelling were measured and recorded in caliper units. Each caliper unit represented 0.5 cm. Redness and swelling were 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 activity), moderate (interfered with activity), and severe (prevented daily activity).	7 days after booster vaccination
Stage2: Percentage of Participants With Systemic Events Within 7 Days After Booster Vaccination: Group 1 Through Group 4	Systemic events fever, vomiting, diarrhea, headache, fatigue, chills, muscle pain and joint pain were recorded in an e-diary. Fever was defined as >=38.0 degree Celsius (C) and categorized to 38.0 to 38.4 degree C, 38.5 to 38.9 degree C, 39.0 to 40.0 degree C and >40.0 degree C. Headache, fatigue, chills, muscle pain and joint pain were graded as mild (did not interfere with activity), moderate (some interference with activity) and severe (prevented daily activity). Vomiting was graded as mild (1-2 times in 24 hours), moderate (>2 times in 24 hours) and severe (required IV hydration). Diarrhea was graded as mild (2-3 loose stools in 24 hours), moderate (4-5 loose stools in 24 hours) and severe (>=6 in 24 hours).	7 days after booster vaccination
Stage2: Percentage of Participants With Antipyretic Medication Use Within 7 Days After Booster Vaccination: Group 1 Through Group 4		7 days after booster vaccination
Stage2: Percentage of Participants With at Least 1 SAE During Booster Vaccination Phase: Group 1 Through Group 4	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. Or that was considered to be an important medical event. SAE of "pregnancy" for one participant during the booster vaccination phase was recorded erroneously and hence it was included in results of Group 4.	Booster vaccination phase: From booster vaccination through 1 month after booster vaccination
Stage2: Percentage of Participants With at Least 1 SAE During the Booster Follow-up Phase: Group 1 Through Group 4	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. Or that was considered to be an important medical event.	Booster follow-up phase: From 1 month after booster vaccination through 6 months after booster vaccination (up to 5 months)
Stage2: Percentage of Participants With at Least 1 SAE Throughout Booster Phase: Group 1 Through Group 4	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. Or that was considered to be an important medical event. SAE of "pregnancy" for one participant during the booster vaccination phase was recorded erroneously and hence it was reported in result of outcome measure 37 for Group 4. Subsequently correction was made by the trial site and not included in subsequent phase/results. Hence, that 1 participant is not included in results of Group 4 here.	Throughout Booster phase: From booster vaccination through 6 months after booster vaccination
Stage2: Percentage of Participants With at Least 1 Medically Attended AE During Booster Vaccination Phase: Group 1 Through Group 4	Medically attended AE was defined as a nonserious AE that resulted in an evaluation at a medical facility.	Booster vaccination phase: From booster vaccination through 1 month after booster vaccination
Stage2: Percentage of Participants With at Least 1 Medically Attended AE During the Booster Follow-up Phase: Group 1 Through Group 4	Medically attended AE was defined as a nonserious AE that resulted in an evaluation at a medical facility.	Booster Follow-up Phase: From 1 month after booster vaccination through 6 months after booster vaccination (up to 5 months)
Stage2: Percentage of Participants With at Least 1 Medically Attended AE Throughout Booster Phase: Group 1 Through Group 4	Medically attended AE was defined as a nonserious AE that resulted in an evaluation at a medical facility.	Throughout Booster Phase: From booster vaccination through 6 months after booster vaccination
Stage2: Percentage of Participants With at Least 1 NDCMC During Booster Vaccination Phase: Group 1 Through Group 4	A NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.	Booster Vaccination Phase: From booster vaccination through 1 month after booster vaccination
Stage2: Percentage of Participants With at Least 1 NDCMC During the Booster Follow-up Phase: Group 1 Through Group 4	A NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.	Booster Follow-up Phase: From 1 month after booster vaccination through 6 months after booster vaccination (up to 5 months)
Stage2: Percentage of Participants With at Least 1 NDCMC Throughout Booster Phase: Group 1 Through Group 4	A NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.	Throughout Booster Phase: From booster vaccination through 6 months after booster vaccination
Stage2: Percentage of Participants With at Least 1 AE During Booster Vaccination Phase: Group 1 Through Group 4	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs did not include local reaction and systemic events collected by systematic approach.	Booster Vaccination Phase: From booster vaccination through 1 month after booster vaccination
Stage2: Percentage of Participants With at Least 1 Immediate AE After Booster Vaccination: Group 1 Through Group 4	Immediate AE was defined as AE occurring within the first 30 minutes after investigational product administration.	30 minutes after booster vaccination
Stage2: Number of Participants Who Missed School/Work Due to AE After Booster Vaccination: Group 1 Through Group 4		Booster Vaccination Phase: From booster vaccination through 1 month after booster vaccination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stage1: Percentage of Participants With hSBA Titer Level >= LLOQ for 4 Primary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined)	Percentage of participants who achieved an hSBA titer >= LLOQ for all 4 primary MenB test strains combined (LLOQ was 1:16 for A22 and 1:8 for A56, B24, and B44) was reported in this outcome measure. Four primary MenB test strains were PMB80 (A22), PMB2001 (A56), PMB2948 (B24) and PMB2707 (B44).	1 month after Vaccination 2
Stage1: Percentage of Participants With hSBA Titer Level >= 1:4, >= 1:8, >= 1:16, >= 1:32, >= 1:64, >= 1:128 for All 4 Primary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined)	Percentage of participants who achieved an hSBA titer >= 1:4, >= 1:8, >= 1:16, >= 1:32, >= 1:64, >= 1:128 for all 4 primary MenB test strains was reported in this outcome measure. Four primary MenB test strains were PMB80 (A22), PMB2001 (A56), PMB2948 (B24) and PMB2707 (B44).	1 month after Vaccination 2 (Vacc 2)
Stage1: hSBA Geometric Mean Titers (GMTs) for All 4 Primary MenB Test Strains Combined 1 Month After Vaccination 2 (Group 2 and 4 Combined)	GMTs were calculated using all participants with valid and determinate hSBA titers at the given time point. LLOQ = 1:16 for A22; 1:8 for A56, B24, and B44. Titers below the LLOQ were set to 0.5 * LLOQ for analysis. Four primary MenB test strains were PMB80 (A22), PMB2001 (A56), PMB2948 (B24) and PMB2707 (B44).	1 month after Vaccination 2 (Vacc 2)
Stage1: Percentage of Participants With hSBA Titer Level >= LLOQ for 10 Secondary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined)	Percentage of participants who achieved an hSBA titer greater than or equal to LLOQ for 10 Secondary MenB test strains combined (LLOQ = 1:16 for A06, A12, and A19; 1:8 for A07, A15, A29, B03, B09, B15, and B16) was reported in this outcome measure.	1 month after Vaccination 2 (Vacc 2)
Stage1: Percentage of Participants With hSBA Titer Level >= 1:4, >= 1:8, >= 1:16, >= 1:32, >= 1:64, >= 1:128 for Each of the 10 Secondary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined)	Percentage of participants who achieved an hSBA titer >= 1:4, >= 1:8, >= 1:16, >= 1:32, >= 1:64, >= 1:128 for each of the 10 secondary MenB test strains was reported in this outcome measure. 10 secondary MenB test strains were PMB3175 (A29), PMB3010 (A06), PMB824 (A12), PMB3040 (A07), PMB1672 (A15), PMB1989 (A19), PMB648 (B16), PMB866 (B09), PMB1256 (B03) and PMB431 (B15).	1 month after Vaccination 2 (Vacc 2)
Stage1: hSBA Geometric Mean Titers (GMTs) for Each of the 10 Secondary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined)	GMTs were calculated using all participants with valid and determinate hSBA titers at the given time point. LLOQ = 1:16 for A06, A12, and A19; 1:8 for A07, A15, A29, B03, B09, B15, and B16. Titers below the LLOQ were set to 0.5*LLOQ for analysis.	1 month after Vaccination 2 (Vacc 2)
Stage1: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=LLOQ for ACWY Test Strains 1 Month After the Vaccination 1: Groups 1, 2, 3 and 4	Percentage of participants who achieved an hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY titer >=LLOQ for ACWY test strains (LLOQ = 1:8 for all MenA, MenC, MenW, and MenY strains) was reported in this outcome measure.	1 month after Vaccination 1
Stage1: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for ACWY Test Strains 1 Month After the Vaccination 1: Groups 1, 2, 3 and 4	Percentage of participants who achieved an hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY titer >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for ACWY test strains was reported in this outcome measure.	1 month after Vaccination 1
Stage1: hSBA Geometric Mean Titers (GMTs) for ACWY Test Strains 1 Month After Vaccination 1: Groups 1, 2, 3 and 4	GMTs were calculated using all participants with valid and determinate hSBA titers at the given time point. LLOQ = 1:8 for all MenA, MenC, MenW, and MenY. Titers below the LLOQ were set to 0.5*LLOQ for analysis.	1 month after Vaccination 1
Stage1: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:8 (or LLOQ, Whichever is Higher) for ACWY Test Strains 1 Month After the Vaccination 1 in Groups 2 and 4, and 1 Month After Vaccination 2 in Groups 1 and 3	Percentage of participants who achieved an hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY titer >= LLOQ for ACWY test strains (LLOQ = 1:8 for all MenA, MenC, MenW, and MenY strains) was reported in this outcome measure.	For Group 2 and 4: 1 month after Vaccination 1; For Group 1 and 3: 1 month after Vaccination 2
Stage1: Percentage of Participants With MenA, MenC, MenW, and MenY Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and, >=1:128 for ACWY Test Strains 1 Month After Vaccination 1 in Groups 2 and 4, and 1 Month After Vaccination 2 in Groups 1 and 3	Percentage of participants who achieved an hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY titer >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for ACWY test strains was reported in this outcome measure.	For Group 2 and 4: 1 month after Vaccination 1; For Group 1 and 3: 1 month after Vaccination 2
Stage1: hSBA GMTs for ACWY Test Strains 1 Month After Vaccination 1 in Groups 2 and 4 and 1 Month After Vaccination 2 in Groups 1 and 3	GMTs were calculated using all participants with valid and determinate hSBA titers at the given time point. LLOQ = 1:8 for all MenA, MenC, MenW, and MenY. Titers below the LLOQ were set to 0.5*LLOQ for analysis.	For Group 2 and 4: 1 month after Vaccination 1; For Group 1 and 3: 1 month after Vaccination 2
Stage1: Percentage of Participants With hSBA Titer Level >= LLOQ for 4 Primary MenB Test Strains 1 Month After Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined)	Percentage of participants who achieved an hSBA titer >=LLOQ for all 4 primary MenB test strains (LLOQ was 1:16 for A22 and 1:8 for A56, B24, and B44) was reported in this outcome measure.	1 month after Vaccination 2 (Vacc 2)
Stage1: Percentage of Participants With >=4 Fold Rise in hSBA for 4 Primary MenB Strains and Composite Response (hSBA >=LLOQ for All 4 Primary MenB Strains Combined) From Baseline-1 Month After Vaccination 2 (Group 1 and 3 Combined;Group 2 and 4 Combined)	Percentage of participants who achieved an hSBA titer greater than or equal to LLOQ for all 4 primary MenB test strains combined (LLOQ was 1:16 for A22 and 1:8 for A56, B24, and B44) was reported in this outcome measure.	Baseline to 1 month after Vaccination 2
Stage1: Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for Each of the 4 Primary MenB Test Strains From 1 Month After Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined)	Percentage of participants who achieved an hSBA titer >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for all 4 primary MenB test strains was reported in this outcome measure.	1 month after Vaccination 2
Stage1: hSBA GMTs for Each of the 4 Primary MenB Test Strains 1 Month After Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined)	GMTs were calculated using all participants with valid and determinate hSBA titers at the given time point. LLOQ =1:16 for A22; 1:8 for A56, B24, and B44. Titers below the LLOQ were set to 0.5*LLOQ for analysis.	1 month after Vaccination 2
Stage1: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW and hSBA-MenY Titers >=1:8 (or LLOQ) for ACWY Test Strains Before Vaccination 1 and Before Vaccination 2: Groups 1, 2, 3 and 4	Percentage of participants who achieved an hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY titer >=LLOQ for ACWY test strains (LLOQ = 1:8 for all MenA, MenC, MenW, and MenY strains) was reported in this outcome measure.	Before Vaccination 1 (Vacc 1) [Day 1], Before Vaccination 2 (Vacc 2) [173 to 194 Days After Visit 1]
Stage1: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for ACWY Test Strains Before Vaccination 1 and Before Vaccination 2: Groups 1, 2, 3 and 4	Percentage of participants who achieved an hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY titer >=1:4, >= :8, >=1:16, >=1:32, >=1:64, >=1:128 for ACWY test strains was reported in this outcome measure.	Before Vaccination 1 (Vacc 1) [Day 1], Before Vaccination 2 (Vacc 2) [173 to 194 Days After Visit 1]
Stage1: hSBA GMTs for ACWY Test Strains Before Vaccination 1 and Before Vaccination 2: Groups 1, 2, 3 and 4	GMTs were calculated using all participants with valid and determinate hSBA titers at the given time point. LLOQ = 1:8 for all MenA, MenC, MenW, and MenY strains. Titers below the LLOQ were set to 0.5*LLOQ for analysis. Confidence intervals were back transformations of confidence levels based on the Student t distribution for the mean logarithm of the concentrations, or the mean of the ratio.	Before Vaccination 1 (Vacc 1) [Day 1], Before Vaccination 2 (Vacc 2) [173 to 194 Days After Visit 1]
Stage1: Percentage of Participants With hSBA Titer Level >=LLOQ for 4 Primary MenB Test Strains Before Vaccination 1 and Before Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined)	Percentage of participants who achieved an hSBA titer >=LLOQ for all 4 primary MenB test strains (LLOQ was 1:16 for A22 and 1:8 for A56, B24, and B44) was reported in this outcome measure.	Before Vaccination 1 (Vacc 1) [Day 1], Before Vaccination 2 (Vacc 2) [173 to 194 Days After Visit 1]
Stage1: Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for Each of the 4 Primary MenB Test Strains Before Vaccination 1 and Before Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined)	Percentage of participants who achieved an hSBA titer >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for each of the 4 primary MenB test strains was reported in this outcome measure.	Before Vaccination 1 (Vacc 1) [Day 1], Before Vaccination 2 (Vacc 2) [173 to 194 Days After Visit 1]
Stage1: hSBA GMTs for Each of the 4 Primary MenB Test Strains Before Vaccination 1 and Before Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined)	GMTs were calculated using all participants with valid and determinate hSBA titers at the given time point. LLOQ =1:16 for A22; 1:8 for A56, B24, and B44. Titers below the LLOQ were set to 0.5*LLOQ for analysis. CIs were back transformations of confidence levels based on the Student t distribution for the mean logarithm of the hSBA titers.	Before Vaccination 1 (Vacc 1) [Day 1], Before Vaccination 2 (Vacc 2) [173 to 194 Days After Visit 1]
Stage2: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:8 (or LLOQ if Higher) for ACWY Test Strains During Persistence Phase: Groups 1, 2, 3 and 4	Percentage of participants who achieved an hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY titer >=LLOQ for ACWY Test Strains (LLOQ = 1:8 for all MenA, MenC, MenW, and MenY strains) was reported in this outcome measure.	12, 24, 36 and 48 months after Vaccination 2 (Vacc 2)
Stage2: Percentage of Participants With hSBA Titer Level >=LLOQ for 4 Primary MenB Test Strains During Persistence Phase (Group 1 and 3 Combined; Group 2 and 4 Combined)	Percentage of participants who achieved an hSBA titer >=LLOQ for all 4 primary MenB test strains (LLOQ was 1:16 for A22 and 1:8 for A56, B24, and B44) was reported in this outcome measure.	12, 24, 36 and 48 months after Vaccination 2 (Vacc 2)
Stage2: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:8 (or >=LLOQ if Higher) for ACWY Test Strains 1 Month After Booster Vaccination: Groups 1 and 3 (Separately)	Percentage of participants who achieved an hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY titer >=LLOQ for ACWY test strains (LLOQ = 1:8 for all MenA, MenC, MenW, and MenY strains) was reported in this outcome measure. Analysis was planned for Group 1 and 3 separately.	1 month after booster vaccination
Stage2: Percentage of Participants With hSBA Titer Level >=LLOQ for 4 Primary MenB Test Strains 1 Month After Booster Vaccination (Group 1 and 3 Combined; Group 2 and 4 Combined)	Percentage of participants who achieved an hSBA titer >=LLOQ for all 4 primary MenB test strains (LLOQ was 1:16 for A22 and 1:8 for A56, B24, and B44) was reported in this outcome measure.	1 month after booster vaccination
Stage1: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1: Group 1 and Group 3	Local reactions (redness, swelling, and pain) at the site of investigational product administration were recorded in e-diary. Redness and swelling were measured and recorded in caliper units. Each caliper unit represented 0.5 cm. Redness and swelling were 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 activity), moderate (interfered with activity), and severe (prevented daily activity).	7 days after Vaccination 1 (Vacc 1)
Stage1: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2: Group 1 and Group 3	Local reactions (redness, swelling, and pain) at the site of investigational product administration were recorded in e-diary. Redness and swelling were measured and recorded in caliper units. Each caliper unit represented 0.5 cm. Redness and swelling were 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 activity), moderate (interfered with activity), and severe (prevented daily activity).	7 days after Vaccination 2 (Vacc 2)
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1: Group 1 and Group 3	Systemic events fever, vomiting, diarrhea, headache, fatigue, chills, muscle pain and joint pain were recorded in an e-diary. Fever was defined as >=38.0 degree C and categorized to 38.0 to 38.4 degree C, 38.5 to 38.9 degree C, 39.0 to 40.0 degree C and >40.0 degree C. Headache, fatigue, chills, muscle pain and joint pain were graded as mild (did not interfere with activity), moderate (some interference with activity) and severe (prevented daily activity). Vomiting was graded as mild (1-2 times in 24 hours), moderate (>2 times in 24 hours) and severe (required IV hydration). Diarrhea was graded as mild (2-3 loose stools in 24 hours), moderate (4-5 loose stools in 24 hours) and severe (>=6 in 24 hours).	7 days after Vaccination 1 (Vacc 1)
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2: Group 1 and Group 3	Systemic events fever, vomiting, diarrhea, headache, fatigue, chills, muscle pain and joint pain were recorded in an e-diary. Fever was defined as >=38.0 degree C and categorized to 38.0 to 38.4 degree C, 38.5 to 38.9 degree C, 39.0 to 40.0 degree C and >40.0 degree C. Headache, fatigue, chills, muscle pain and joint pain were graded as mild (did not interfere with activity), moderate (some interference with activity) and severe (prevented daily activity). Vomiting was graded as mild (1-2 times in 24 hours), moderate (>2 times in 24 hours) and severe (required IV hydration). Diarrhea was graded as mild (2-3 loose stools in 24 hours), moderate (4-5 loose stools in 24 hours) and severe (>=6 in 24 hours).	7 days after Vaccination 2 (Vacc 2)
Stage1: Percentage of Participants With Antipyretic Medication Use 30 Days After Vaccination 1: Group 1 and Group 3		30 days after Vaccination 1
Stage1: Percentage of Participants With Antipyretic Medication Use 30 Days After Vaccination 2: Group 1 and Group 3		30 days after Vaccination 2
Stage1: Percentage of Participants With at Least 1 SAE Within 30 Days After Vaccination 1: Group 1 and Group 3	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. Or that was considered to be an important medical event.	30 days after Vaccination 1
Stage1: Percentage of Participants With at Least 1 SAE Within 30 Days After Vaccination 2: Group 1 and Group 3	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. Or that was considered to be an important medical event.	30 days after Vaccination 2
Stage1: Percentage of Participants With at Least 1 SAE Within 30 Days After Any Vaccination: Group 1 and Group 3	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. Or that was considered to be an important medical event.	30 days after any vaccination
Stage1: Percentage of Participants With at Least 1 SAE During the Vaccination Phase: Group 1 and Group 3	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. Or that was considered to be an important medical event.	Stage 1 Vaccination Phase: From Vaccination 1 through 1 month after Vaccination 2 (7 Months)
Stage1: Percentage of Participants With at Least 1 SAE During the Stage 1 Follow-up Phase: Group 1 and Group 3	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. Or that was considered to be an important medical event. There was one participant who did not meet criteria for Stage 1 follow-up safety population. The subject's SAE happened in the follow-up phase but was not included in the follow-up safety population for Stage 1 (but in the safety population for Stage 1). Therefore, the SAE was not included in the follow-up table but in the broadly defined throughout Stage 1 table.	Stage 1 Follow-up phase: From 1 month after Vaccination 2 through 6 months after Vaccination 2 (5 Months)
Stage1: Percentage of Participants With at Least 1 SAE Throughout the Stage 1: Group 1 and Group 3	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. Or that was considered to be an important medical event. There was one participant who did not meet criteria for Stage 1 follow-up safety population. The subject's SAE happened in the follow-up phase but was not included in the follow-up safety population for Stage 1 (but in the safety population for Stage 1). Therefore, the SAE was not included in the follow-up table but in the broadly defined throughout Stage 1 table.	Throughout Stage 1: From the Vaccination 1 through 6 months after Vaccination 2 (12 Months)
Stage1: Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Vaccination 1: Group 1 and Group 3	Medically attended AE was defined as a nonserious AE that resulted in an evaluation at a medical facility.	30 days after vaccination 1
Stage1: Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Vaccination 2: Group 1 and Group 3	Medically attended AE was defined as a nonserious AE that resulted in an evaluation at a medical facility.	30 days after vaccination 2
Stage1: Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Any Vaccination: Group 1 and Group 3	Medically attended AE was defined as a nonserious AE that resulted in an evaluation at a medical facility.	30 days after any vaccination
Stage1: Percentage of Participants With at Least 1 Medically Attended AE During the Stage 1 Vaccination Phase: Group 1 and Group 3	Medically attended AE was defined as a nonserious AE that resulted in an evaluation at a medical facility.	Stage 1 Vaccination Phase: From Vaccination 1 through 1 month after Vaccination 2 (7 Months)
Stage1: Percentage of Participants With at Least 1 Medically Attended AE During the Stage 1 Follow-up Phase: Group 1 and Group 3	Medically attended AE was defined as a nonserious AE that resulted in an evaluation at a medical facility.	Stage 1 Follow-up phase: From 1 month after Vaccination 2 through 6 months after Vaccination 2 (5 Months)
Stage1: Percentage of Participants With at Least 1 Medically Attended AE Throughout the Stage 1: Group 1 and Group 3	Medically attended AE was defined as a nonserious AE that resulted in an evaluation at a medical facility.	Throughout Stage 1: From the Vaccination 1 through 6 months after Vaccination 2 (12 Months)
Stage1: Percentage of Participants With at Least 1 NDCMC Within 30 Days After Vaccination 1: Group 1 and Group 3	A NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.	30 days after vaccination 1
Stage1: Percentage of Participants With at Least 1 NDCMC Within 30 Days After Vaccination 2: Group 1 and Group 3	A NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.	30 days after vaccination 2
Stage1: Percentage of Participants With at Least 1 NDCMC Within 30 Days After Any Vaccination: Group 1 and Group 3	A NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.	30 days after any vaccination
Stage1: Percentage of Participants With at Least 1 NDCMC During the Stage 1 Vaccination Phase: Group 1 and Group 3	A NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.	Stage 1 Vaccination Phase: From Vaccination 1 through 1 month after Vaccination 2 (7 Months)
Stage1: Percentage of Participants With at Least 1 NDCMC During the Stage 1 Follow-up Phase: Group 1 and Group 3	A NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.	Stage 1 Follow-up phase: From 1 month after Vaccination 2 through 6 months after Vaccination 2 (5 Months)
Stage1: Percentage of Participants With at Least 1 NDCMC Throughout the Stage 1: Group 1 and Group 3	A NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.	Throughout Stage 1: From the Vaccination 1 through 6 months after Vaccination 2 (12 Months)
Stage1: Percentage of Participants With at Least 1 AE Within 30 Days After Vaccination 1: Group 1 and Group 3	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs did not include local reaction and systemic events collected by systematic approach.	30 days after vaccination 1
Stage1: Percentage of Participants With at Least 1 AE Within 30 Days After Vaccination 2: Group 1 and Group 3	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs did not include local reaction and systemic events collected by systematic approach.	30 days after vaccination 2
Stage1: Percentage of Participants With at Least 1 AE Within 30 Days After Vaccination Any Vaccination: Group 1 and Group 3	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs did not include local reaction and systemic events collected by systematic approach.	30 days after any vaccination
Stage1: Percentage of Participants With at Least 1 AE During the Stage 1 Vaccination Phase: Group 1 and Group 3	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs did not include local reaction and systemic events collected by systematic approach.	Stage 1 Vaccination Phase: From Vaccination 1 through 1 month after Vaccination 2 (7 Months)
Stage1: Percentage of Participants With at Least 1 Immediate AE After Vaccination 1: Group 1 and Group 3	Immediate AE was defined as AE occurring within the first 30 minutes after investigational product administration.	30 minutes after Vaccination 1
Stage1: Percentage of Participants With at Least 1 Immediate AE After Vaccination 2: Group 1 and Group 3	Immediate AE was defined as AE occurring within the first 30 minutes after investigational product administration.	30 minutes after Vaccination 2
Stage1: Number of Participants Who Missed School/Work Due to AE During the Stage 1 Vaccination Phase: Group 1 and Group 3		Stage 1 Vaccination Phase: From Vaccination 1 through 1 month after Vaccination 2 (7 Months)

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, 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): April 24, 2017
• Primary Completion (Actual): October 25, 2022
• Study Completion (Actual): October 25, 2022

Study Registration Dates

• First Submitted: April 26, 2017
• First Submitted That Met QC Criteria: April 26, 2017
• First Posted (Actual): May 1, 2017

Study Record Updates

• Last Update Posted (Actual): August 8, 2023
• Last Update Submitted That Met QC Criteria: August 4, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: B1971057; 2016-004421-17 (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