Study of an Investigational Pentavalent Meningococcal ABCYW Vaccine in Adults and Adolescents

A Phase I/II, Randomized, Descriptive, Safety and Immunogenicity Study to Assess Pentavalent Meningococcal ABCYW Vaccine Formulations in Adults (18 to 25 Years of Age) and Adolescents (10 to 17 Years of Age).

The purpose of VAN00010 study is to assess the safety and immunogenicity of the investigational pentavalent meningococcal ABCYW vaccine in adults and adolescents.

The study duration will be up to 12 months for all participants.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers; Meningococcal Immunisation
• Intervention / Treatment: Biological: Pentavalent Meningococcal ABCYW vaccine; Biological: Placebo; Biological: MenACYW conjugate vaccine; Biological: Meningococcal group B vaccine; Biological: Meningococcal group B vaccine; Biological: MenACYW conjugate vaccine; Biological: MenABCYW conjugate vaccine

Detailed Description

The study duration will be approximately 12 months for all participants

• Study Type: Interventional
• Enrollment (Actual): 1215
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Puerto Rico
  • San Juan, Puerto Rico, 00918
    • Investigational Site Number : 6300001
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35216
      • Accel Research Site - Birmingham Clinical Research Unit- Site Number : 8400080
    • Guntersville, Alabama, United States, 35976-2206
      • Lakeview Clinical Research Site Number : 8400029
  • Arizona
    • Tempe, Arizona, United States, 85281
      • Alliance for Multispecialty Research- Phoenix- Site Number : 8400056
  • Arkansas
    • Harrisburg, Arkansas, United States, 72432
      • Harrisburg Family Medical Center Site Number : 8400070
  • California
    • Anaheim, California, United States, 92806
      • Smart Cures Clinical Research Site Number : 8400072
    • Canoga Park, California, United States, 91303
      • Hope Clinical Research, LLC- Site Number : 8400001
    • Fair Oaks, California, United States, 95628
      • Apex Research Group Site Number : 8400071
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20016
      • Velocity Clinical Research-Washington DC Site Number : 8400102
  • Florida
    • DeLand, Florida, United States, 32720-0834
      • Accel Clinical Research-Deland Clinical Research Unit- Site Number : 8400081
    • Gainesville, Florida, United States, 32607
      • SIMEDHealth, LLC- Site Number : 8400045
    • Largo, Florida, United States, 33777
      • Accel Research Sites-St. Petersburg-Largo- Site Number : 8400082
    • Medley, Florida, United States, 33166
      • South Florida Research Organization Site Number : 8400086
    • Miami, Florida, United States, 33126
      • Life Arc Research-Miami Site Number : 8400094
    • Miami Lakes, Florida, United States, 33014
      • Charisma Medical and Research center Site Number : 8400097
    • Orlando, Florida, United States, 32829
      • Accel Research - Nona Pediatric Center Site Number : 8400079
    • Ormond Beach, Florida, United States, 32174
      • Ormond Beach Clinical Research- Site Number : 8400073
    • Tampa, Florida, United States, 33613
      • PAS Research Site Number : 8400032
    • Tampa, Florida, United States, 33614
      • VICIS Clinical Research-Tampa Site Number : 8400065
    • Tampa, Florida, United States, 33609
      • Palm Harbor Dermatology- Site Number : 8400030
  • Idaho
    • Idaho Falls, Idaho, United States, 83404
      • Leavitt Clinical Research-Idaho Falls- Site Number : 8400075
    • Idaho Falls, Idaho, United States, 83404
      • Snake River Research, PLLC- Site Number : 8400100
  • Illinois
    • Peoria, Illinois, United States, 61614
      • AES Peoria- Site Number : 8400090
  • Indiana
    • Evansville, Indiana, United States, 47712
      • AMR Evansville Site Number : 8400062
  • Kansas
    • Newton, Kansas, United States, 67114
      • AMR - Newton- Site Number : 8400104
  • Kentucky
    • Bardstown, Kentucky, United States, 40004
      • ~Kentucky Pediatics / Adult Research- Site Number : 8400009
    • Lexington, Kentucky, United States, 40517
      • Michael W. Simon, MD, PSC- Site Number : 8400026
  • Michigan
    • Dearborn Heights, Michigan, United States, 48127-2234
      • Vida Clinical Studies Site Number : 8400084
    • Dearborn Heights, Michigan, United States, 48127-2234
      • Vida Clinical Studies- Site Number : 8400084
  • Nebraska
    • Lincoln, Nebraska, United States, 68526
      • Alivation Research (Primary Care) Site Number : 8400046
    • Lincoln, Nebraska, United States, 68516
      • Be Well Clinical Studies- Site Number : 8400077
    • Omaha, Nebraska, United States, 68114
      • Quality Clinical Research, Inc.- Site Number : 8400074
    • Omaha, Nebraska, United States, 68134
      • Velocity Clinical Research, Omaha- Site Number : 8400066
  • New Mexico
    • Albuquerque, New Mexico, United States, 87107
      • Velocity Clinical Research-Albuquerque- Site Number : 8400101
  • New York
    • The Bronx, New York, United States, 10456
      • Prime Global Research, Inc. Site Number : 8400043
  • North Carolina
    • Monroe, North Carolina, United States, 28112
      • Monroe Biomedical Research - Site Number : 8400099
  • South Carolina
    • Columbia, South Carolina, United States, 29223
      • SPICA Clinical Research Site Number : 8400098
    • North Charleston, South Carolina, United States, 29405
      • Coastal Carolina Research Center - N Charleston- Site Number : 8400050
    • Simpsonville, South Carolina, United States, 29681
      • Tribe Clinical Research at Parkside Pediatrics-Five Forks Site Number : 8400049
  • Tennessee
    • Tullahoma, Tennessee, United States, 37388
      • Pediatric Clinical Trials Tullahoma- Site Number : 8400020
  • Texas
    • Houston, Texas, United States, 77063
      • New Horizon Medical Group-Houston Site Number : 8400069
    • Houston, Texas, United States, 77081
      • DM Clinical Research- Bellaire- Site Number : 8400052
    • Pearland, Texas, United States, 77584
      • Advances in Health- Pearland- Site Number : 8400078
    • Round Rock, Texas, United States, 78681
      • Be Well Clinical Studies -Round Rock Site Number : 8400053
  • Utah
    • Bountiful, Utah, United States, 84010
      • Progressive Clinical Research- Site Number : 8400028
    • Kaysville, Utah, United States, 84037
      • AMR Utah-Wee Care Pediatrics-Kaysville- Site Number : 8400106
    • Murray, Utah, United States, 84107
      • Alliance for Multispecialty Research- Site Number : 8400107

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria: - Aged 18 to 25 years or 10 to 17 years on the day of inclusion

• Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, and judgment of the Investigator.
• Participants who are either unvaccinated with MenACWY vaccine or have received a single previous dose of MenACWY vaccine at least 4 years prior to study enrollment Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply:
• Known or suspected congenital or acquired immunodeficiency
• History of any Neisseria meningitidis infection
• At high risk for meningococcal infection during the study
• Individuals with active tuberculosis
• History of Guillain-Barré syndrome
• Alcohol, prescription drug, or substance abuse that, in the opinion of the Investigator, might interfere with the study conduct or completion NOTE: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1: MenPenta Formulation 1; Participants (ACWY naive and primed adults or adolescents) will receive injections of the pentavalent meningococcal ABCYW vaccine and placebo	Biological: Pentavalent Meningococcal ABCYW vaccine; Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular (IM); Other Names: MenPenta; Biological: Placebo; Pharmaceutical form:Solution for injection in vial-Route of administration:Intramuscular (IM)
Experimental: Group 2: MenPenta Formulation 2; Participants (ACWY naive and primed adults or adolescents) will receive injections of the pentavalent meningococcal ABCYW vaccine and placebo	Biological: Pentavalent Meningococcal ABCYW vaccine; Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular (IM); Other Names: MenPenta; Biological: Placebo; Pharmaceutical form:Solution for injection in vial-Route of administration:Intramuscular (IM)
Active Comparator: Group 3: Bexsero® + Menveo®; Participants (ACWY naive and primed adults or adolescents) will receive injections of Bexsero® + Menveo® vaccine	Biological: MenACYW conjugate vaccine; Pharmaceutical form:Solution for injection in vial-Route of administration:Intramuscular (IM); Other Names: MenQuadFi®; Biological: Meningococcal group B vaccine; Pharmaceutical form:Suspension for injection in pre-filled syringe-Route of administration:Intramuscular (IM); Other Names: Trumenba®; Biological: Meningococcal group B vaccine; Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular (IM); Other Names: Sanofi MenB; Biological: MenACYW conjugate vaccine; Pharmaceutical form:Powder and solvent for solution for injection-Route of administration:Intramuscular (IM); Other Names: Menveo®
Active Comparator: Group 4: Trumenba® + Menveo®; Participants (ACWY naive and primed adults or adolescents) will receive injections of Trumenba® + Menveo® vaccine	Biological: MenACYW conjugate vaccine; Pharmaceutical form:Solution for injection in vial-Route of administration:Intramuscular (IM); Other Names: MenQuadFi®; Biological: Meningococcal group B vaccine; Pharmaceutical form:Suspension for injection in pre-filled syringe-Route of administration:Intramuscular (IM); Other Names: Trumenba®; Biological: Meningococcal group B vaccine; Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular (IM); Other Names: Sanofi MenB; Biological: MenACYW conjugate vaccine; Pharmaceutical form:Powder and solvent for solution for injection-Route of administration:Intramuscular (IM); Other Names: Menveo®
Active Comparator: Group 5: MenQuadfi®; Participants (ACWY naive and primed adults or adolescents) will receive injections of MenQuadfi® vaccine and placebo	Biological: Placebo; Pharmaceutical form:Solution for injection in vial-Route of administration:Intramuscular (IM); Biological: MenACYW conjugate vaccine; Pharmaceutical form:Solution for injection in vial-Route of administration:Intramuscular (IM); Other Names: MenQuadFi®; Biological: MenACYW conjugate vaccine; Pharmaceutical form:Powder and solvent for solution for injection-Route of administration:Intramuscular (IM); Other Names: Menveo®
Experimental: Group 6: Sanofi MenB; Participants (ACWY naive and primed adults or adolescents) will receive injections of SP MenB vaccine and placebo	Biological: Placebo; Pharmaceutical form:Solution for injection in vial-Route of administration:Intramuscular (IM); Biological: Meningococcal group B vaccine; Pharmaceutical form:Suspension for injection in pre-filled syringe-Route of administration:Intramuscular (IM); Other Names: Trumenba®; Biological: Meningococcal group B vaccine; Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular (IM); Other Names: Sanofi MenB
Active Comparator: Group 7: PENBRAYA; Participants (ACWY naive and primed adolescents) will receive injections of PENBRAYA vaccine and placebo	Biological: MenABCYW conjugate vaccine; Pharmaceutical form: Suspension for injection Route of administration: Intramuscular (IM); Other Names: PENBRAYATM

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with immediate adverse events (AEs)	Unsolicited systemic AEs that occur within 30 minutes after vaccination	Within 30 minutes after each vaccination
Number of participants with solicited injection site reactions or systemic reactions	Pre-defined solicited injection site reactions and systemic reactions that are pre-listed in the diary cards and CRF	Within 7 days after each vaccination
Number of participants with serious adverse events (SAEs)	SAEs (including adverse events of special interest [AESIs]) reported throughout the study	From baseline up to 12 months
Number of participants with out-of-range biological test results		Before each vaccination up to 7 days after primary vaccination visits in the sentinel cohorts (the first 5 participants enrolled in each vaccine group) of each age group
Number of participants with unsolicited AEs	Non-serious AEs other than solicited reactions	Within 30 days after each vaccination
Number of participants with medically attended adverse events (MAAEs)	An MAAE is a new onset or a worsening of a condition that prompts the participant or participant's parent/legally acceptable representative to seek unplanned medical advice at a physician's office or Emergency Department	From baseline up to 12 months
hSBA meningococcal serogroups A, C, W, and Y vaccine seroresponse pre-dose and 1 month after the second dose in adolescent participants	Seroresponse defined as post-second vaccination titers ≥ 1:16 for participants with pre-vaccination hSBA titers < 1:4 or post-second vaccination titers ≥ 4 times the pre-vaccination titer for participants with a pre-vaccination titer more than or equal to the lower limit of quantification (LLOQ)	Day 01 (pre-dose) and Day 211 (for Group 1 to 7)
hSBA meningococcal serogroups A, C, W, and Y antibody titers pre-dose and 1 month after the second dose in adolescent participants	hSBA titers ≥ 1:8	Day 211 (for Group 1 to 7)
Geometric mean titers (GMTs) of Antibodies against Meningococcal Serogroups A, C, W and Y pre-dose and 1 month after the second dose in adolescent participants	Geometric mean titers	Day 01 (pre-dose) and Day 31 Day 211 (for Group 1 to 7)
Percentage of participants with hSBA titers more or equal to lower limit of quantification (LLOQ) against each of serogroups A, C, W, and Y in adolescent participants		Day 01 (pre-dose) Day 211 (for Group 1 to 7)
hSBA meningococcal serogroup B seroresponse pre-dose and 1 month after second dose in adolescent participants	Seroresponse defined as a 4-fold increase in hSBA titers	Day 01 (pre-dose) and Day 211 (for Group 1 to 7)
Percentage of Participants With Meningococcal Antibody Titers against meningococcal serogroup B (reference MenB strains) ≥ 1:4 pre-dose 1 and 1 month post-second dose in adolescent participants	hSBA titers ≥ 1:4 for reference MenB strains	Day 01 (pre-dose) and Day 211 (for Group 1 to 7)
Percentage of Participants With Meningococcal Antibody Titers against meningococcal serogroup B (reference MenB strains) ≥ 1:8 pre-dose 1 and 1 month post-second dose in adolescent participants	hSBA titers ≥ 1:8 for reference MenB strains	Day 01 (pre-dose) and Day 211 (for Group 1 to 7)
Geometric mean titers (GMTs) of Antibodies against Meningococcal Serogroup B (reference MenB strains) pre-dose 1 and 1 month post-second dose in adolescent participants	Geometric mean titers for the reference MenB strains	Day 01 (pre-dose) and Day 211 (for Group 1 to 7)
Percentage of participants with hSBA titers more or equal to lower limit of quantification (LLOQ) against each and all serogroups B (reference MenB strains) in adolescent participants		Day 01 (pre-dose) and Day 211 (for Group 1 to 7)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
hSBA meningococcal serogroups A, C, W, and Y vaccine seroresponse at each timepoint	Seroresponse defined as post-vaccination titers ≥ 1:16 for participants with pre-vaccination titers < 1:4 or post-vaccination titer ≥ 4 times the pre-vaccination titer for participants with pre-dose 1 vaccination titers more than the lower limit of quantification (LLOQ)	D01 (pre-dose) and D31 (post-dose 1 and pre-dose 2), D61 (post-dose 2), D181 (pre-dose 3) and D211 (post-dose 3) for adults (Group 1-6). D01 (pre-dose) and D31 (post-dose 1), D181 (pre-dose 2) and D211 (post-dose 2) for adolescents (Group 1-7)
hSBA meningococcal serogroups A, C, W, and Y antibody titers at each timepoint	hSBA titers ≥ 1:8 post-vaccination	D01 (pre-dose) and D31 (post-dose 1 and pre-dose 2), D61 (post-dose 2), D181 (pre-dose 3) and D211 (post-dose 3) for adults (Group 1-6). D01 (pre-dose) and D31 (post-dose 1), D181 (pre-dose 2) and D211 (post-dose 2) for adolescents (Group 1-7)
Geometric mean titers (GMTs) of Antibodies against Meningococcal Serogroups A, C, W and Y at each timepoint	Geometric mean titers	D01 (pre-dose) and D31 (post-dose 1 and pre-dose 2), D61 (post-dose 2), D181 (pre-dose 3) and D211 (post-dose 3) for adults (Group 1-6). D01 (pre-dose) and D31 (post-dose 1), D181 (pre-dose 2) and D211 (post-dose 2) for adolescents (Group 1-7)
Percentage of participants with hSBA titers more or equal to LLOQ against each of serogroups A, C, W, and Y at each timepoint		D01 (pre-dose) and D31 (post-dose 1 and pre-dose 2), D61 (post-dose 2), D181 (pre-dose 3) and D211 (post-dose 3) for adults (Group 1-6). D01 (pre-dose) and D31 (post-dose 1), D181 (pre-dose 2) and D211 (post-dose 2) for adolescents (Group 1-7)
hSBA meningococcal serogroup B (reference MenB strains) vaccine seroresponse at each timepoint	Seroresponse defined as a 4-fold increase in hSBA titers	D01 (pre-dose) and D31 (post-dose 1 and pre-dose 2), D61 (post-dose 2), D181 (pre-dose 3) and D211 (post-dose 3) for adults (Group 1-6). D01 (pre-dose) and D31 (post-dose 1), D181 (pre-dose 2) and D211 (post-dose 2) for adolescents (Group 1-7)
Percentage of Participants With Meningococcal Antibody Titers against meningococcal serogroup B (reference MenB strains) ≥ 1:4 at each timepoint	hSBA titers ≥ 1:4 for reference MenB strains	D01 (pre-dose) and D31 (post-dose 1 and pre-dose 2), D61 (post-dose 2), D181 (pre-dose 3) and D211 (post-dose 3) for adults (Group 1-6). D01 (pre-dose) and D31 (post-dose 1), D181 (pre-dose 2) and D211 (post-dose 2) for adolescents (Group 1-7)
Percentage of Participants With Meningococcal Antibody Titers against meningococcal serogroup B (reference MenB strains) ≥ 1:8 at each timepoint	hSBA titers ≥ 1:8 reference MenB strains	D01 (pre-dose) and D31 (post-dose 1 and pre-dose 2), D61 (post-dose 2), D181 (pre-dose 3) and D211 (post-dose 3) for adults (Group 1-6). D01 (pre-dose) and D31 (post-dose 1), D181 (pre-dose 2) and D211 (post-dose 2) for adolescents (Group 1-7)
Geometric mean titers (GMTs) of Antibodies against Meningococcal Serogroup B (reference MenB strains) at each timepoint	Geometric mean titers for reference MenB strains	D01 (pre-dose) and D31 (post-dose 1 and pre-dose 2), D61 (post-dose 2), D181 (pre-dose 3) and D211 (post-dose 3) for adults (Group 1-6). D01 (pre-dose) and D31 (post-dose 1), D181 (pre-dose 2) and D211 (post-dose 2) for adolescents (Group 1-7)
Percentage of participants with hSBA composite seroresponse titers more or equal to LLOQ for reference MenB strains for each timepoint		D01 (pre-dose) and D31 (post-dose 1 and pre-dose 2), D61 (post-dose 2), D181 (pre-dose 3) and D211 (post-dose 3) for adults (Group 1-6). D01 (pre-dose) and D31 (post-dose 1), D181 (pre-dose 2) and D211 (post-dose 2) for adolescents (Group 1-7)
hSBA meningococcal serogroup B (reference and additional MenB strains) vaccine seroresponse pre-dose 1 and 1 month post-second and third dose in adolescent participants	Seroresponse defined as a 4-fold increase in hSBA titers from D01 to post-vaccination for reference and additional MenB strains	Day 01 (pre-dose), Day 61 (post-dose 2) and Day 211 (post-dose 3) (for Group 1 to 6 for adults) and Day 211 (for Group 1 to 7 for adolescents)
Percentage of Participants With Meningococcal Antibody Titers against meningococcal serogroup B (reference and additional MenB strains) ≥ 1:4 pre-dose 1 and 1 month post-second and third dose in adolescent participants	hSBA titers ≥ 1:4 for reference and additional MenB strains	Day 01 (pre-dose), Day 61 (post-dose 2) and Day 211 (post-dose 3) (for Group 1 to 6 for adults) and Day 211 (for Group 1 to 7 for adolescents)
Percentage of Participants With Meningococcal Antibody Titers against meningococcal serogroup B (reference and additional MenB strains) ≥ 1:8 pre-dose 1 and 1 month post-second and third dose in adolescent participants	hSBA titers ≥ 1:8 for reference and additional MenB strains	Day 01 (pre-dose), Day 61 (post-dose 2) and Day 211 (post-dose 3) (for Group 1 to 6 for adults) and Day 211 (for Group 1 to 7 for adolescents)
Geometric mean titers (GMTs) of Antibodies against Meningococcal Serogroup B (reference and additional MenB strains) pre-dose 1 and 1 month post-second and third dose in adolescent participants	Geometric mean titers for reference and additional MenB strains	Day 01 (pre-dose), Day 61 (post-dose 2) and Day 211 (post-dose 3) (for Group 1 to 6 for adults) and Day 211 (for Group 1 to 7 for adolescents)
Percentage of participants with hSBA composite seroresponse titers more or equal to LLOQ reference and additional MenB strains in adolescent participants		Day 01 (pre-dose), Day 61 (post-dose 2) and Day 211 (post-dose 3) (for Group 1 to 6 for adults) and Day 211 (for Group 1 to 7 for adolescents)
hSBA meningococcal serogroups A, C, W, and Y vaccine seroresponse 1 month after the third dose in adult participants	Seroresponse defined as post-third vaccination titers ≥ 1:16 for participants with pre-vaccination hSBA titers < 1:4 or post-third vaccination titers ≥ 4 times the pre-vaccination titer for participants with a pre-vaccination titer more than the lower limit of quantification (LLOQ)	Day 01 (pre-dose) and Day 211 (for Group 1 to 6)
hSBA meningococcal serogroups A, C, W, and Y antibody titers pre-dose and 1 month after the third dose in adult participants		Day 01 (pre-dose) and Day 211 (for Group 1 to 6)
Geometric mean titers (GMTs) of Antibodies against Meningococcal Serogroups A, C, W and Y pre-dose and 1 month after the third dose in adult participants		Day 01 (pre-dose) and Day 211 (for Group 1 to 6)
Percentage of participants with hSBA titers more or equal to LLOQ against each of serogroups A, C, W, and Y in adult participants		Day 01 (pre-dose) and Day 211 (for Group 1 to 6)
hSBA meningococcal serogroup B (reference MenB strains) seroresponse pre-dose and 1 month after third dose in adult participants		Day 01 (pre-dose) and Day 211 (for Group 1 to 6)
Percentage of Participants With Meningococcal Antibody Titers against meningococcal serogroup B (reference MenB strains) ≥ 1:4 pre-dose 1 and 1 month post-third dose in adult participants		Day 01 (pre-dose) and Day 211 (for Group 1 to 6)
Percentage of Participants With Meningococcal Antibody Titers against meningococcal serogroup B (reference MenB strains) ≥ 1:8 pre-dose 1 and 1 month post-third dose in adult participants		Day 01 (pre-dose) and Day 211 (for Group 1 to 6)
Geometric mean titers (GMTs) of Antibodies against Meningococcal Serogroup B (reference MenB strains) pre-dose 1 and 1 month post-third dose in adult participants		Day 01 (pre-dose) and Day 211 (for Group 1 to 6)
Percentage of participants with hSBA titers more or equal to lower limit of quantification (LLOQ) against each and all serogroups B (reference MenB strains) in adult participants		Day 01 (pre-dose) and Day 211 (for Group 1 to 6)

Collaborators and Investigators

• Sponsor: Sanofi Pasteur, a Sanofi Company
• Investigators: Study Director: Clinical Sciences & Operations, Sanofi

Publications and helpful links

Helpful Links

• VAN00010 Plain Language Results Summary

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2023
• Primary Completion (Actual): August 27, 2025
• Study Completion (Actual): August 27, 2025

Study Registration Dates

• First Submitted: October 26, 2023
• First Submitted That Met QC Criteria: November 8, 2023
• First Posted (Actual): November 13, 2023

Study Record Updates

• Last Update Posted (Actual): January 13, 2026
• Last Update Submitted That Met QC Criteria: January 10, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Neisseriaceae Infections; Meningococcal Infections; Biological Products; Complex Mixtures; Bacterial Vaccines; Vaccines; 4CMenB vaccine; MenB-FHbp vaccine; Meningococcal Vaccines
• Other Study ID Numbers: VAN00010 (Sanofi Identifier); U1111-1272-6824 (Registry Identifier: ICTRP); 2023-000924-13 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Drug and device information, study documents

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