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

NCT06128733 | Completed Phase 1 FDA Drug

• 3 other identifiers: VAN00010U1111-1272-68242023-000924-13
• Study Type: interventional
• Target: 1,215
• Locations: 2 countries
• Sites: 47

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.

Conditions

Meningococcal Immunisation; Healthy Volunteers

Outcome Measures

Primary Outcomes (15)

• 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 unsolicited AEs

  Non-serious AEs other than solicited reactions

  Within 30 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 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

• 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

• 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 Outcomes (23)

• 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)

• 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)

• 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)

• 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

  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)

Study Arms (7)

Group 1: MenPenta Formulation 1

EXPERIMENTAL

Participants (ACWY naive and primed adults or adolescents) will receive injections of the pentavalent meningococcal ABCYW vaccine and placebo

Biological: Pentavalent Meningococcal ABCYW vaccine; Biological: Placebo

Group 2: MenPenta Formulation 2

EXPERIMENTAL

Participants (ACWY naive and primed adults or adolescents) will receive injections of the pentavalent meningococcal ABCYW vaccine and placebo

Biological: Pentavalent Meningococcal ABCYW vaccine; Biological: Placebo

Group 3: Bexsero® + Menveo®

ACTIVE COMPARATOR

Participants (ACWY naive and primed adults or adolescents) will receive injections of Bexsero® + Menveo® vaccine

Biological: Meningococcal group B vaccine; Biological: MenACYW conjugate vaccine

Group 4: Trumenba® + Menveo®

ACTIVE COMPARATOR

Participants (ACWY naive and primed adults or adolescents) will receive injections of Trumenba® + Menveo® vaccine

Biological: Meningococcal group B vaccine; Biological: MenACYW conjugate vaccine

Group 5: MenQuadfi®

ACTIVE COMPARATOR

Participants (ACWY naive and primed adults or adolescents) will receive injections of MenQuadfi® vaccine and placebo

Biological: MenACYW conjugate vaccine; Biological: Placebo

Group 6: Sanofi MenB

EXPERIMENTAL

Participants (ACWY naive and primed adults or adolescents) will receive injections of SP MenB vaccine and placebo

Biological: Meningococcal group B vaccine; Biological: Placebo

Group 7: PENBRAYA

ACTIVE COMPARATOR

Participants (ACWY naive and primed adolescents) will receive injections of PENBRAYA vaccine and placebo

Biological: MenABCYW conjugate vaccine

Interventions

Pentavalent Meningococcal ABCYW vaccine BIOLOGICAL

Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular (IM)

Also known as: MenPenta

Group 1: MenPenta Formulation 1; Group 2: MenPenta Formulation 2

Placebo BIOLOGICAL

Pharmaceutical form:Solution for injection in vial-Route of administration:Intramuscular (IM)

Group 1: MenPenta Formulation 1; Group 2: MenPenta Formulation 2; Group 5: MenQuadfi®; Group 6: Sanofi MenB

Meningococcal group B vaccine BIOLOGICAL

Pharmaceutical form:Suspension for injection in pre-filled syringe-Route of administration:Intramuscular (IM)

Also known as: Bexsero®

Group 3: Bexsero® + Menveo®

MenACYW conjugate vaccine BIOLOGICAL

Pharmaceutical form:Solution for injection in vial-Route of administration:Intramuscular (IM)

Also known as: MenQuadFi®

Group 5: MenQuadfi®

MenABCYW conjugate vaccine BIOLOGICAL

Pharmaceutical form: Suspension for injection Route of administration: Intramuscular (IM)

Also known as: PENBRAYATM

Group 7: PENBRAYA

Eligibility Criteria

• Age: 10 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, and judgment of the Investigator.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (47)

Accel Research Site - Birmingham Clinical Research Unit- Site Number : 8400080

Birmingham, Alabama, 35216, United States

Location

Lakeview Clinical Research Site Number : 8400029

Guntersville, Alabama, 35976-2206, United States

Location

Alliance for Multispecialty Research- Phoenix- Site Number : 8400056

Tempe, Arizona, 85281, United States

Location

Harrisburg Family Medical Center Site Number : 8400070

Harrisburg, Arkansas, 72432, United States

Location

Smart Cures Clinical Research Site Number : 8400072

Anaheim, California, 92806, United States

Location

Hope Clinical Research, LLC- Site Number : 8400001

Canoga Park, California, 91303, United States

Location

Apex Research Group Site Number : 8400071

Fair Oaks, California, 95628, United States

Location

Velocity Clinical Research-Washington DC Site Number : 8400102

Washington D.C., District of Columbia, 20016, United States

Location

Accel Clinical Research-Deland Clinical Research Unit- Site Number : 8400081

DeLand, Florida, 32720-0834, United States

Location

SIMEDHealth, LLC- Site Number : 8400045

Gainesville, Florida, 32607, United States

Location

Accel Research Sites-St. Petersburg-Largo- Site Number : 8400082

Largo, Florida, 33777, United States

Location

South Florida Research Organization Site Number : 8400086

Medley, Florida, 33166, United States

Location

Life Arc Research-Miami Site Number : 8400094

Miami, Florida, 33126, United States

Location

Charisma Medical and Research center Site Number : 8400097

Miami Lakes, Florida, 33014, United States

Location

Accel Research - Nona Pediatric Center Site Number : 8400079

Orlando, Florida, 32829, United States

Location

Ormond Beach Clinical Research- Site Number : 8400073

Ormond Beach, Florida, 32174, United States

Location

Palm Harbor Dermatology- Site Number : 8400030

Tampa, Florida, 33609, United States

Location

PAS Research Site Number : 8400032

Tampa, Florida, 33613, United States

Location

VICIS Clinical Research-Tampa Site Number : 8400065

Tampa, Florida, 33614, United States

Location

Leavitt Clinical Research-Idaho Falls- Site Number : 8400075

Idaho Falls, Idaho, 83404, United States

Location

Snake River Research, PLLC- Site Number : 8400100

Idaho Falls, Idaho, 83404, United States

Location

AES Peoria- Site Number : 8400090

Peoria, Illinois, 61614, United States

Location

AMR Evansville Site Number : 8400062

Evansville, Indiana, 47712, United States

Location

AMR - Newton- Site Number : 8400104

Newton, Kansas, 67114, United States

Location

~Kentucky Pediatics / Adult Research- Site Number : 8400009

Bardstown, Kentucky, 40004, United States

Location

Michael W. Simon, MD, PSC- Site Number : 8400026

Lexington, Kentucky, 40517, United States

Location

Vida Clinical Studies Site Number : 8400084

Dearborn Heights, Michigan, 48127-2234, United States

Location

Vida Clinical Studies- Site Number : 8400084

Dearborn Heights, Michigan, 48127-2234, United States

Location

Be Well Clinical Studies- Site Number : 8400077

Lincoln, Nebraska, 68516, United States

Location

Alivation Research (Primary Care) Site Number : 8400046

Lincoln, Nebraska, 68526, United States

Location

Quality Clinical Research, Inc.- Site Number : 8400074

Omaha, Nebraska, 68114, United States

Location

Velocity Clinical Research, Omaha- Site Number : 8400066

Omaha, Nebraska, 68134, United States

Location

Velocity Clinical Research-Albuquerque- Site Number : 8400101

Albuquerque, New Mexico, 87107, United States

Location

Prime Global Research, Inc. Site Number : 8400043

The Bronx, New York, 10456, United States

Location

Monroe Biomedical Research - Site Number : 8400099

Monroe, North Carolina, 28112, United States

Location

SPICA Clinical Research Site Number : 8400098

Columbia, South Carolina, 29223, United States

Location

Coastal Carolina Research Center - N Charleston- Site Number : 8400050

North Charleston, South Carolina, 29405, United States

Location

Tribe Clinical Research at Parkside Pediatrics-Five Forks Site Number : 8400049

Simpsonville, South Carolina, 29681, United States

Location

Pediatric Clinical Trials Tullahoma- Site Number : 8400020

Tullahoma, Tennessee, 37388, United States

Location

New Horizon Medical Group-Houston Site Number : 8400069

Houston, Texas, 77063, United States

Location

DM Clinical Research- Bellaire- Site Number : 8400052

Houston, Texas, 77081, United States

Location

Advances in Health- Pearland- Site Number : 8400078

Pearland, Texas, 77584, United States

Location

Be Well Clinical Studies -Round Rock Site Number : 8400053

Round Rock, Texas, 78681, United States

Location

Progressive Clinical Research- Site Number : 8400028

Bountiful, Utah, 84010, United States

Location

AMR Utah-Wee Care Pediatrics-Kaysville- Site Number : 8400106

Kaysville, Utah, 84037, United States

Location

Alliance for Multispecialty Research- Site Number : 8400107

Murray, Utah, 84107, United States

Location

Investigational Site Number : 6300001

San Juan, 00918, Puerto Rico

Location

Related Links

• VAN00010 Plain Language Results Summary

MeSH Terms

Interventions

4CMenB vaccine; MenB-FHbp vaccine; Meningococcal Vaccines

Intervention Hierarchy (Ancestors)

Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Modified double-blind: in order to maintain the blind, a placebo injection will be given and blood sample will be collected from all participants at each visit
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2023
• First Posted: November 13, 2023
• Study Start: October 31, 2023
• Primary Completion: August 27, 2025
• Study Completion: August 27, 2025
• Last Updated: January 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

PR (1); US (46)