AzTrials
AzTrials

Meningococcal VaccinePhase 3NCT03135834

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 study testing MenABCWY, Saline and rLP2086 in people with Meningococcal Vaccine, run by Pfizer at 75 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 10 to 25 yearsHealthy volunteers can take part
Conditions the study is for
Meningococcal Vaccine
What is being tested?
MenABCWY, Saline and rLP2086
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,610 participants
Where
75 sitesin 4 countries
Study dates
24 Apr 2017to 25 Oct 2022
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 10 to 25 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • Male or female subject aged >=10 and <26 years at the time of 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

Who cannot join

  • 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.

Trial locations and contacts

75 sites in 4 countries.

75 sites in 4 countries

United States60 sites

  • Benchmark Research

    Austin, Texas, 78705

  • Kentucky Pediatric/Adult Research

    Bardstown, Kentucky, 40004

  • Meridian Clinical Research, LLC

    Binghamton, New York, 13901

  • United Medical Associates

    Binghamton, New York, 13901

  • Meridian Clinical Research, LLC

    Binghamton, New York, 13905

  • United Medical Associates

    Binghamton, New York, 13905

  • Alabama Clinical Therapeutics, LLC

    Birmingham, Alabama, 35205

  • Internal Medicine and Pediatric Associates of Bristol, PC

    Bristol, Tennessee, 37620

  • PMG Research of Bristol, LLC

    Bristol, Tennessee, 37620

  • PI-Coor Clinical Research, LLC

    Burke, Virginia, 22015

  • Charleston Pediatrics, PA

    Charleston, South Carolina, 29403

  • Pediatric Research of Charlottesville, LLC

    Charlottesville, Virginia, 22902

  • Meridian Clinical Research, LLC

    Cincinnati, Ohio, 45246

  • Velocity Clinical Research, Inc.

    Cleveland, Ohio, 44122

  • Aventiv Research Inc.

    Columbus, Ohio, 43213

  • Ohio Pediatric Research Association, Inc.

    Dayton, Ohio, 45414

  • Avail Clinical Research, LLC

    DeLand, Florida, 32720

  • J. Lewis Research Inc. / Foothill Family Clinic Draper

    Draper, Utah, 84020

  • Regional Clinical Research, Inc

    Endwell, New York, 13760

  • Liberty Family Practice

    Erie, Pennsylvania, 16508

  • Horizon Research Group of Opelousas, LLC

    Eunice, Louisiana, 70535

  • Texas Health Care, PLLC

    Fort Worth, Texas, 76104

  • Ventavia Research Group, LLC

    Fort Worth, Texas, 76104

  • Benchmark Research

    Fort Worth, Texas, 76135

  • Synexus Clinical Research US, Inc./Fountain Hills Family Practice, P.C.

    Fountain Hills, Arizona, 85268

  • Methodist Physicians Clinic/CCT Research

    Fremont, Nebraska, 68025

  • Harrisburg Family Medical Center

    Harrisburg, Arkansas, 72432

  • ACC Pediatric Research

    Haughton, Louisiana, 71037

  • Optimal Research, LLC

    Huntsville, Alabama, 35802

  • Health Awareness, Inc.

    Jupiter, Florida, 33458

  • Holston Medical Group

    Kingsport, Tennessee, 37660

  • Paradigm Clinical Research Centers, Inc.

    La Mesa, California, 91942

  • Optimal Research, LLC

    Melbourne, Florida, 32934

  • PMG Research of Charleston, LLC

    Mt. Pleasant, South Carolina, 29464

  • Clinical Research Associates, Inc.

    Nashville, Tennessee, 37203

  • Alliance for Multispecialty Research, LLC

    Newton, Kansas, 67114

  • Meridian Clinical Research, LLC

    Norfolk, Nebraska, 68701

  • Coastal Carolina Research Center

    North Charleston, South Carolina, 29405

  • Lynn Health Science Institute

    Oklahoma City, Oklahoma, 73112

  • Meridian Clinical Research, LLC

    Omaha, Nebraska, 68134

  • Optimal Research

    Peoria, Illinois, 61614

  • Acrc Trials

    Plano, Texas, 75024

  • North Texas Family Medicine

    Plano, Texas, 75093

  • Capitol Pediatrics & Adolescent Center PLLC

    Raleigh, North Carolina, 27609

  • Rochester Clinical Research, Inc.

    Rochester, New York, 14609

  • J. Lewis Research, Inc. / Foothill Family Clinic

    Salt Lake City, Utah, 84109

  • J. Lewis Research, Inc. / Foothill Family Clinic South

    Salt Lake City, Utah, 84121

  • Clinical Trials of Texas, Inc.

    San Antonio, Texas, 78229

  • California Research Foundation

    San Diego, California, 92123

  • Kaiser Permanente Santa Clara

    Santa Clara, California, 95051

  • Meridian Clinical Research LLC

    Savannah, Georgia, 31406

  • Meridian Clinical Research

    Sioux City, Iowa, 51106

  • J. Lewis Research, Inc. / Jordan River Family Medicine

    South Jordan, Utah, 84095

  • Clinical Research Consortium

    Tempe, Arizona, 85283

  • Meridian Clinical Research, LLC

    Vestal, New York, 13850

  • Regional Clinical Research, Inc

    Vestal, New York, 13850

  • Heartland Research Associates, LLC

    Wichita, Kansas, 67205

  • Alliance For Multispecialty Research (AMR)

    Wichita, Kansas, 67207

  • Alliance for Multispecialty Research, LLC

    Wichita, Kansas, 67207

  • Heartland Research Associates, LLC

    Wichita, Kansas, 67207

Other trials in United States

Finland10 sites

  • Espoo Vaccine Research Clinic

    Espoo, 02230

  • Helsinki South Vaccine Research Clinic

    Helsinki, 00100

  • Helsinki East Vaccine Research Clinic

    Helsinki, 00930

  • Jarvenpaa Vaccine Research Clinic

    Jarvenpaa, 04400

  • Kokkola Vaccine Research Clinic

    Kokkola, 67100

  • Oulu Vaccine Research Clinic

    Oulu, 90220

  • Pori Vaccine Research Clinic

    Pori, 28100

  • Seinajoki Vaccine Research Clinic

    Seinäjoki, 60100

  • Tampere Vaccine Research Clinic

    Tampere, 33100

  • Turku Vaccine Research Clinic

    Turku, 20520

Other trials in Finland

Poland3 sites

  • Jerzy Brzostek Prywatny Gabinet Lekarski

    Dębica, 39-200

  • Hanna Czajka Indywidualna Specjalistyczna Praktyka Lekarska

    Krakow, 30-348

  • Oddzial Pediatrii i Neurologii Dzieciecej, Krakowski Szpital Specjalistyczny im. Jana Pawla II

    Krakow, 31-202

Other trials in Poland

Czechia2 sites

  • Ordinace praktickeho lekare pro deti a dorost

    Jindřichův Hradec, 377 01

  • MEDICENTRUM 6 s.r.o. - Ordinace praktickeho lekare pro deti a dorost

    Prague, 160 00

Other trials in Czechia

About this study

Official title: 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.

Being tested
MenABCWY, Saline, rLP2086, MenACWY-CRM

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MenABCWYBiological

    N meningitidis group A, B, C, W, and Y vaccine

  • SalineBiological

    Placebo

  • rLP2086Biological

    Bivalent recombinant lipoprotein 2086 vaccine

  • MenACWY-CRMBiological

    meningococcal group A, C, W-135, and Y conjugate vaccine

Study groups in NCT03135834
Study groupRoleWhat they receive
Group 1 (ACWY Naive subjects, MenABCWY/Saline)ExperimentalACWY Naive subjects, MenABCWY/Saline
Receives: Biological: MenABCWY; Biological: Saline
Group 2 (ACWY Naive subjects, rLP2086/MenACWY-CRM)ExperimentalACWY Naive subjects, rLP2086/MenACWY-CRM
Receives: Biological: rLP2086; Biological: MenACWY-CRM
Group 3 (ACWY Experienced subjects, MenABCWY/Saline)ExperimentalACWY Experienced subjects, MenABCWY/Saline
Receives: Biological: MenABCWY; Biological: Saline
Group 4 (ACWY Experienced subjects, rLP2086/MenACWY-CRM)ExperimentalACWY Experienced subjects, rLP2086/MenACWY-CRM
Receives: Biological: rLP2086; Biological: MenACWY-CRM

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 1 month after Vaccination 2

  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.

    Measured: From Baseline (blood draw prior to Vaccination 1) to 1 month after Vaccination 2

  3. 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).

    Measured: 7 days after Vaccination 1

  4. 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).

    Measured: 7 days after Vaccination 2

  5. 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).

    Measured: 7 days after Vaccination 1

  6. 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).

    Measured: 7 days after Vaccination 2

  7. Stage1: Percentage of Participants With Antipyretic Medication Use Within 7 Days After Vaccination 1 (Group 2 and 4 Combined)

    Measured: 7 days after Vaccination 1

  8. Stage1: Percentage of Participants With Antipyretic Medication Use Within 7 Days After Vaccination 2 (Group 2 and 4 Combined)

    Measured: 7 days after Vaccination 2

  9. 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.

    Measured: 30 days after Vaccination 1

  10. 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.

    Measured: 30 days after Vaccination 2

  11. 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.

    Measured: 30 days after any vaccination

  12. 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.

    Measured: Stage 1 Vaccination Phase: From Vaccination 1 through 1 month after Vaccination 2 (7 Months)

  13. 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.

    Measured: Stage 1 Follow-up phase: From 1 month after Vaccination 2 through 6 months after Vaccination 2 (5 Months)

  14. 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.

    Measured: Throughout Stage 1: From the Vaccination 1 through 6 months after Vaccination 2 (12 Months)

  15. 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.

    Measured: 30 days after Vaccination 1

  16. 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.

    Measured: 30 days after Vaccination 2

  17. 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.

    Measured: 30 days after any vaccination

  18. 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.

    Measured: Stage 1 Vaccination Phase: From Vaccination 1 through 1 month after Vaccination 2 (7 Months)

  19. 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.

    Measured: Stage 1 Follow-up phase: From 1 month after Vaccination 2 through 6 months after Vaccination 2 (5 Months)

  20. 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.

    Measured: Throughout Stage 1: From the Vaccination 1 through 6 months after Vaccination 2 (12 Months)

  21. 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.

    Measured: 30 days after Vaccination 1

  22. 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.

    Measured: 30 days after Vaccination 2

  23. 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.

    Measured: 30 days after any Vaccination

  24. 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.

    Measured: Stage 1 Vaccination Phase: From Vaccination 1 through 1 month after Vaccination 2 (7 Months)

  25. 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.

    Measured: Stage 1 Follow-up phase: From 1 month after Vaccination 2 through 6 months after Vaccination 2 (5 Months)

  26. 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.

    Measured: Throughout Stage 1: From the Vaccination 1 through 6 months after Vaccination 2 (12 Months)

  27. 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.

    Measured: 30 days after Vaccination 1

  28. 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.

    Measured: 30 days after Vaccination 2

  29. 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.

    Measured: 30 days after any vaccination

  30. 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.

    Measured: Stage 1 Vaccination Phase: From Vaccination 1 through 1 month after Vaccination 2 (7 Months)

  31. 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.

    Measured: 30 minutes after Vaccination 1

  32. 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.

    Measured: 30 minutes after Vaccination 2

  33. Stage1: Number of Participants Who Missed School/Work Due to AE During the Stage 1 Vaccination Phase (Group 2 and 4 Combined)

    Measured: Stage 1 Vaccination Phase: From Vaccination 1 through 1 month after Vaccination 2 (7 Months)

  34. 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).

    Measured: 7 days after booster vaccination

  35. 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).

    Measured: 7 days after booster vaccination

  36. Stage2: Percentage of Participants With Antipyretic Medication Use Within 7 Days After Booster Vaccination: Group 1 Through Group 4

    Measured: 7 days after booster vaccination

  37. 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.

    Measured: Booster vaccination phase: From booster vaccination through 1 month after booster vaccination

  38. 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.

    Measured: Booster follow-up phase: From 1 month after booster vaccination through 6 months after booster vaccination (up to 5 months)

  39. 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.

    Measured: Throughout Booster phase: From booster vaccination through 6 months after booster vaccination

  40. 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.

    Measured: Booster vaccination phase: From booster vaccination through 1 month after booster vaccination

  41. 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.

    Measured: Booster Follow-up Phase: From 1 month after booster vaccination through 6 months after booster vaccination (up to 5 months)

  42. 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.

    Measured: Throughout Booster Phase: From booster vaccination through 6 months after booster vaccination

  43. 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.

    Measured: Booster Vaccination Phase: From booster vaccination through 1 month after booster vaccination

  44. 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.

    Measured: Booster Follow-up Phase: From 1 month after booster vaccination through 6 months after booster vaccination (up to 5 months)

  45. 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.

    Measured: Throughout Booster Phase: From booster vaccination through 6 months after booster vaccination

  46. 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.

    Measured: Booster Vaccination Phase: From booster vaccination through 1 month after booster vaccination

  47. 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.

    Measured: 30 minutes after booster vaccination

  48. Stage2: Number of Participants Who Missed School/Work Due to AE After Booster Vaccination: Group 1 Through Group 4

    Measured: Booster Vaccination Phase: From booster vaccination through 1 month after booster vaccination

Secondary outcomes (57)

  1. 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).

    Measured: 1 month after Vaccination 2

  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).

    Measured: 1 month after Vaccination 2 (Vacc 2)

  3. 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).

    Measured: 1 month after Vaccination 2 (Vacc 2)

  4. 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.

    Measured: 1 month after Vaccination 2 (Vacc 2)

  5. 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).

    Measured: 1 month after Vaccination 2 (Vacc 2)

  6. 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.

    Measured: 1 month after Vaccination 2 (Vacc 2)

  7. 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.

    Measured: 1 month after Vaccination 1

  8. 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.

    Measured: 1 month after Vaccination 1

  9. 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.

    Measured: 1 month after Vaccination 1

  10. 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.

    Measured: For Group 2 and 4: 1 month after Vaccination 1; For Group 1 and 3: 1 month after Vaccination 2

  11. 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.

    Measured: For Group 2 and 4: 1 month after Vaccination 1; For Group 1 and 3: 1 month after Vaccination 2

  12. 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.

    Measured: For Group 2 and 4: 1 month after Vaccination 1; For Group 1 and 3: 1 month after Vaccination 2

  13. 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.

    Measured: 1 month after Vaccination 2 (Vacc 2)

  14. 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.

    Measured: Baseline to 1 month after Vaccination 2

  15. 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.

    Measured: 1 month after Vaccination 2

  16. 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.

    Measured: 1 month after Vaccination 2

  17. 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.

    Measured: Before Vaccination 1 (Vacc 1) [Day 1], Before Vaccination 2 (Vacc 2) [173 to 194 Days After Visit 1]

  18. 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.

    Measured: Before Vaccination 1 (Vacc 1) [Day 1], Before Vaccination 2 (Vacc 2) [173 to 194 Days After Visit 1]

  19. 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.

    Measured: Before Vaccination 1 (Vacc 1) [Day 1], Before Vaccination 2 (Vacc 2) [173 to 194 Days After Visit 1]

  20. 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.

    Measured: Before Vaccination 1 (Vacc 1) [Day 1], Before Vaccination 2 (Vacc 2) [173 to 194 Days After Visit 1]

  21. 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.

    Measured: Before Vaccination 1 (Vacc 1) [Day 1], Before Vaccination 2 (Vacc 2) [173 to 194 Days After Visit 1]

  22. 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.

    Measured: Before Vaccination 1 (Vacc 1) [Day 1], Before Vaccination 2 (Vacc 2) [173 to 194 Days After Visit 1]

  23. 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.

    Measured: 12, 24, 36 and 48 months after Vaccination 2 (Vacc 2)

  24. 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.

    Measured: 12, 24, 36 and 48 months after Vaccination 2 (Vacc 2)

  25. 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.

    Measured: 1 month after booster vaccination

  26. 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.

    Measured: 1 month after booster vaccination

  27. 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).

    Measured: 7 days after Vaccination 1 (Vacc 1)

  28. 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).

    Measured: 7 days after Vaccination 2 (Vacc 2)

  29. 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).

    Measured: 7 days after Vaccination 1 (Vacc 1)

  30. 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).

    Measured: 7 days after Vaccination 2 (Vacc 2)

  31. Stage1: Percentage of Participants With Antipyretic Medication Use 30 Days After Vaccination 1: Group 1 and Group 3

    Measured: 30 days after Vaccination 1

  32. Stage1: Percentage of Participants With Antipyretic Medication Use 30 Days After Vaccination 2: Group 1 and Group 3

    Measured: 30 days after Vaccination 2

  33. 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.

    Measured: 30 days after Vaccination 1

  34. 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.

    Measured: 30 days after Vaccination 2

  35. 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.

    Measured: 30 days after any vaccination

  36. 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.

    Measured: Stage 1 Vaccination Phase: From Vaccination 1 through 1 month after Vaccination 2 (7 Months)

  37. 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.

    Measured: Stage 1 Follow-up phase: From 1 month after Vaccination 2 through 6 months after Vaccination 2 (5 Months)

  38. 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.

    Measured: Throughout Stage 1: From the Vaccination 1 through 6 months after Vaccination 2 (12 Months)

  39. 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.

    Measured: 30 days after vaccination 1

  40. 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.

    Measured: 30 days after vaccination 2

  41. 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.

    Measured: 30 days after any vaccination

  42. 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.

    Measured: Stage 1 Vaccination Phase: From Vaccination 1 through 1 month after Vaccination 2 (7 Months)

  43. 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.

    Measured: Stage 1 Follow-up phase: From 1 month after Vaccination 2 through 6 months after Vaccination 2 (5 Months)

  44. 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.

    Measured: Throughout Stage 1: From the Vaccination 1 through 6 months after Vaccination 2 (12 Months)

  45. 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.

    Measured: 30 days after vaccination 1

  46. 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.

    Measured: 30 days after vaccination 2

  47. 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.

    Measured: 30 days after any vaccination

  48. 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.

    Measured: Stage 1 Vaccination Phase: From Vaccination 1 through 1 month after Vaccination 2 (7 Months)

  49. 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.

    Measured: Stage 1 Follow-up phase: From 1 month after Vaccination 2 through 6 months after Vaccination 2 (5 Months)

  50. 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.

    Measured: Throughout Stage 1: From the Vaccination 1 through 6 months after Vaccination 2 (12 Months)

  51. 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.

    Measured: 30 days after vaccination 1

  52. 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.

    Measured: 30 days after vaccination 2

  53. 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.

    Measured: 30 days after any vaccination

  54. 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.

    Measured: Stage 1 Vaccination Phase: From Vaccination 1 through 1 month after Vaccination 2 (7 Months)

  55. 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.

    Measured: 30 minutes after Vaccination 1

  56. 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.

    Measured: 30 minutes after Vaccination 2

  57. Stage1: Number of Participants Who Missed School/Work Due to AE During the Stage 1 Vaccination Phase: Group 1 and Group 3

    Measured: Stage 1 Vaccination Phase: From Vaccination 1 through 1 month after Vaccination 2 (7 Months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 May 2017
  2. Study start24 Apr 2017
  3. Primary completion25 Oct 2022
  4. Study completion25 Oct 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,610 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03135834
Sponsor's protocol ID
B1971057
Other IDs
2016-004421-17, 2016
Status last verified
Aug 2023
First submitted
26 Apr 2017
Last updated
8 Aug 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Publications

  • Peterson J, Drazan D, Moughan B, Maguire JD, Zolotas L, Maansson R, O'Neill R, Peyrani P, Jodar L, Gruber WC, Anderson AS, Beeslaar J. Randomized trial showing persistence of hSBA titers elicited by a pentavalent meningococcal MenABCWY vaccine for up to 4 years following a primary series and safety and immunogenicity of a booster dose. Vaccine. 2025 Jan 1;43(Pt 1):126469. doi: 10.1016/j.vaccine.2024.126469. Epub 2024 Nov 8.

    PubMed 39520893

  • Peterson J, Drazan D, Czajka H, Maguire J, Pregaldien JL, Seppa I, Maansson R, O'Neill R, Balmer P, Jodar L, Jansen KU, Anderson AS, Perez JL, Beeslaar J. Immunogenicity and safety of a pentavalent meningococcal ABCWY vaccine in adolescents and young adults: an observer-blind, active-controlled, randomised trial. Lancet Infect Dis. 2023 Dec;23(12):1370-1382. doi: 10.1016/S1473-3099(23)00191-3. Epub 2023 Aug 11.

    PubMed 37579773

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing MenABCWY, Saline and rLP2086 in people with Meningococcal Vaccine, run by Pfizer at 75 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 75 sites in United States, Finland, Poland, Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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) (time frame: 1 month after Vaccination 2). The study lists 48 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03135834, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2023; AzTrials last refreshed its copy on 7 Nov 2026.

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