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

Phase 1

Completed

• Conditions: Meningococcal Immunisation; Healthy Volunteers
• Interventions: Biological: Pentavalent Meningococcal ABCYW vaccine; Biological: Meningococcal group B vaccine; Biological: MenABCYW conjugate vaccine; Biological: Placebo; Biological: MenACYW conjugate vaccine

• Registration Number: NCT06128733
• Lead Sponsor: Sanofi Pasteur, a Sanofi Company

Brief Summary

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.

Detailed Description

The study duration will be approximately 12 months for all participants

Study Timeline

• Study First Submitted: 2023-10-26
• Study Start: 2023-10-31
• Study First Submitted QC: 2023-11-08
• Study First Posted: 2023-11-13
• Primary Completion: 2025-07-21
• Study Completion: 2025-07-21
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-28
• Last Update Posted: 2025-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1215

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1: MenPenta Formulation 1	Pentavalent Meningococcal ABCYW vaccine	Participants (ACWY naive and primed adults or adolescents) will receive injections of the pentavalent meningococcal ABCYW vaccine and placebo
Group 1: MenPenta Formulation 1	Placebo	Participants (ACWY naive and primed adults or adolescents) will receive injections of the pentavalent meningococcal ABCYW vaccine and placebo
Group 2: MenPenta Formulation 2	Pentavalent Meningococcal ABCYW vaccine	Participants (ACWY naive and primed adults or adolescents) will receive injections of the pentavalent meningococcal ABCYW vaccine and placebo
Group 2: MenPenta Formulation 2	Placebo	Participants (ACWY naive and primed adults or adolescents) will receive injections of the pentavalent meningococcal ABCYW vaccine and placebo
Group 3: Bexsero® + Menveo®	MenACYW conjugate vaccine	Participants (ACWY naive and primed adults or adolescents) will receive injections of Bexsero® + Menveo® vaccine
Group 4: Trumenba® + Menveo®	MenACYW conjugate vaccine	Participants (ACWY naive and primed adults or adolescents) will receive injections of Trumenba® + Menveo® vaccine
Group 5: MenQuadfi®	MenACYW conjugate vaccine	Participants (ACWY naive and primed adults or adolescents) will receive injections of MenQuadfi® vaccine and placebo
Group 6: Sanofi MenB	Placebo	Participants (ACWY naive and primed adults or adolescents) will receive injections of SP MenB vaccine and placebo
Group 5: MenQuadfi®	Placebo	Participants (ACWY naive and primed adults or adolescents) will receive injections of MenQuadfi® vaccine and placebo
Group 6: Sanofi MenB	Meningococcal group B vaccine	Participants (ACWY naive and primed adults or adolescents) will receive injections of SP MenB vaccine and placebo
Group 7: PENBRAYA	MenABCYW conjugate vaccine	Participants (ACWY naive and primed adolescents) will receive injections of PENBRAYA vaccine and placebo
Group 3: Bexsero® + Menveo®	Meningococcal group B vaccine	Participants (ACWY naive and primed adults or adolescents) will receive injections of Bexsero® + Menveo® vaccine
Group 4: Trumenba® + Menveo®	Meningococcal group B vaccine	Participants (ACWY naive and primed adults or adolescents) will receive injections of Trumenba® + Menveo® vaccine

Primary Outcome Measures

Name	Time	Method
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
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	Day 01 (pre-dose) and Day 211 (for Group 1 to 7)	hSBA titers ≥ 1:8 for reference MenB strains
Number of participants with solicited injection site reactions or systemic reactions	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
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)
Number of participants with unsolicited AEs	Within 30 days after each vaccination	Non-serious AEs other than solicited reactions
Number of participants with serious adverse events (SAEs)	From baseline up to 12 months	SAEs (including adverse events of special interest \[AESIs\]) reported throughout the study
hSBA meningococcal serogroups A, C, W, and Y antibody titers pre-dose and 1 month after the second dose in adolescent participants	Day 211 (for Group 1 to 7)	hSBA titers ≥ 1:8
hSBA meningococcal serogroup B seroresponse pre-dose and 1 month after second dose in adolescent participants	Day 01 (pre-dose) and Day 211 (for Group 1 to 7)	Seroresponse defined as a 4-fold increase in hSBA titers
Number of participants with medically attended adverse events (MAAEs)	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
hSBA meningococcal serogroups A, C, W, and Y vaccine seroresponse pre-dose and 1 month after the second dose in adolescent participants	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)
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	Day 01 (pre-dose) and Day 31 Day 211 (for Group 1 to 7)	Geometric mean titers
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	Day 01 (pre-dose) and Day 211 (for Group 1 to 7)	hSBA titers ≥ 1:4 for reference MenB strains
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	Day 01 (pre-dose) and Day 211 (for Group 1 to 7)	Geometric mean titers for the reference MenB strains
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)
Number of participants with immediate adverse events (AEs)	Within 30 minutes after each vaccination	Unsolicited systemic AEs that occur within 30 minutes after vaccination

Secondary Outcome Measures

Name	Time	Method
hSBA meningococcal serogroups A, C, W, and Y vaccine seroresponse 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)	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)
hSBA meningococcal serogroups A, C, W, and Y antibody titers 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 titers ≥ 1:8 post-vaccination
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	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
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	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
hSBA meningococcal serogroup B (reference MenB strains) vaccine seroresponse 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)	Seroresponse defined as a 4-fold increase in hSBA titers
Percentage of Participants With Meningococcal Antibody Titers against meningococcal serogroup B (reference MenB strains) ≥ 1:4 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 titers ≥ 1:4 for reference MenB strains
Geometric mean titers (GMTs) of Antibodies against Meningococcal 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)	Geometric mean titers
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)
Percentage of Participants With Meningococcal Antibody Titers against meningococcal serogroup B (reference MenB strains) ≥ 1:8 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 titers ≥ 1:8 reference MenB strains
Geometric mean titers (GMTs) of Antibodies against Meningococcal Serogroup B (reference MenB strains) 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)	Geometric mean titers for reference MenB strains
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	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
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	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
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	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)
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)

Trial Locations

Locations (47)

Accel Research Site - Birmingham Clinical Research Unit- Site Number : 8400080; 🇺🇸 Birmingham, Alabama, United States

Lakeview Clinical Research Site Number : 8400029; 🇺🇸 Guntersville, Alabama, United States

Alliance for Multispecialty Research- Phoenix- Site Number : 8400056; 🇺🇸 Tempe, Arizona, United States

Harrisburg Family Medical Center Site Number : 8400070; 🇺🇸 Harrisburg, Arkansas, United States

Smart Cures Clinical Research Site Number : 8400072; 🇺🇸 Anaheim, California, United States

Hope Clinical Research, LLC- Site Number : 8400001; 🇺🇸 Canoga Park, California, United States

Apex Research Group Site Number : 8400071; 🇺🇸 Fair Oaks, California, United States

Velocity Clinical Research-Washington DC Site Number : 8400102; 🇺🇸 Washington D.C., District of Columbia, United States

Accel Clinical Research-Deland Clinical Research Unit- Site Number : 8400081; 🇺🇸 DeLand, Florida, United States

SIMEDHealth, LLC- Site Number : 8400045; 🇺🇸 Gainesville, Florida, United States

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