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

January 10, 2026 updated by: Sanofi Pasteur, a Sanofi Company

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study duration will be approximately 12 months for all participants

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1215

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Trial Transparency email recommended (Toll free for US & Canada)
  • Phone Number: option 6 800-633-1610
  • Email: Contact-US@sanofi.com

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of participants with immediate adverse events (AEs)
Time Frame: Within 30 minutes after each vaccination
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
Time Frame: Within 7 days after each vaccination
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)
Time Frame: From baseline up to 12 months
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
Time Frame: 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
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
Time Frame: Within 30 days after each vaccination
Non-serious AEs other than solicited reactions
Within 30 days after each vaccination
Number of participants with medically attended adverse events (MAAEs)
Time Frame: From baseline up to 12 months
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
Time Frame: Day 01 (pre-dose) and Day 211 (for Group 1 to 7)
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
Time Frame: Day 211 (for Group 1 to 7)
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
Time Frame: Day 01 (pre-dose) and Day 31 Day 211 (for Group 1 to 7)
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
Time Frame: Day 01 (pre-dose) Day 211 (for Group 1 to 7)
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
Time Frame: Day 01 (pre-dose) and Day 211 (for Group 1 to 7)
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
Time Frame: Day 01 (pre-dose) and Day 211 (for Group 1 to 7)
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
Time Frame: Day 01 (pre-dose) and Day 211 (for Group 1 to 7)
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
Time Frame: Day 01 (pre-dose) and Day 211 (for Group 1 to 7)
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
Time Frame: Day 01 (pre-dose) and Day 211 (for Group 1 to 7)
Day 01 (pre-dose) and Day 211 (for Group 1 to 7)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
hSBA meningococcal serogroups A, C, W, and Y vaccine seroresponse at each timepoint
Time Frame: 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)
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
Time Frame: 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 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
Time Frame: 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
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
Time Frame: 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)
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
Time Frame: 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)
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
Time Frame: 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 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
Time Frame: 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 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
Time Frame: 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 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
Time Frame: 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)
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
Time Frame: 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)
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
Time Frame: 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 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
Time Frame: 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 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
Time Frame: 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 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
Time Frame: 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)
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
Time Frame: Day 01 (pre-dose) and Day 211 (for Group 1 to 6)
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
Time Frame: Day 01 (pre-dose) and Day 211 (for Group 1 to 6)
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
Time Frame: Day 01 (pre-dose) and Day 211 (for Group 1 to 6)
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
Time Frame: Day 01 (pre-dose) and Day 211 (for Group 1 to 6)
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
Time Frame: Day 01 (pre-dose) and Day 211 (for Group 1 to 6)
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
Time Frame: Day 01 (pre-dose) and Day 211 (for Group 1 to 6)
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
Time Frame: Day 01 (pre-dose) and Day 211 (for Group 1 to 6)
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
Time Frame: Day 01 (pre-dose) and Day 211 (for Group 1 to 6)
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
Time Frame: Day 01 (pre-dose) and Day 211 (for Group 1 to 6)
Day 01 (pre-dose) and Day 211 (for Group 1 to 6)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sanofi Pasteur, a Sanofi Company

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clinical Sciences & Operations, Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 31, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 27, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 27, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 26, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 8, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 13, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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