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

NCT ID: NCT06128733

Last Updated: 2026-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

1215 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-31

Study Completion Date

2025-08-27

Brief Summary

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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

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The study duration will be approximately 12 months for all participants

Conditions

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Meningococcal Immunisation Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
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

Study Groups

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Group 1: MenPenta Formulation 1

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

Group Type EXPERIMENTAL

Pentavalent Meningococcal ABCYW vaccine

Intervention Type BIOLOGICAL

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

Placebo

Intervention Type BIOLOGICAL

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

Group 2: MenPenta Formulation 2

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

Group Type EXPERIMENTAL

Pentavalent Meningococcal ABCYW vaccine

Intervention Type BIOLOGICAL

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

Placebo

Intervention Type BIOLOGICAL

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

Group 3: Bexsero® + Menveo®

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

Group Type ACTIVE_COMPARATOR

Meningococcal group B vaccine

Intervention Type BIOLOGICAL

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

MenACYW conjugate vaccine

Intervention Type BIOLOGICAL

Pharmaceutical form:Powder and solvent for solution for injection-Route of administration:Intramuscular (IM)

Group 4: Trumenba® + Menveo®

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

Group Type ACTIVE_COMPARATOR

Meningococcal group B vaccine

Intervention Type BIOLOGICAL

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

MenACYW conjugate vaccine

Intervention Type BIOLOGICAL

Pharmaceutical form:Powder and solvent for solution for injection-Route of administration:Intramuscular (IM)

Group 5: MenQuadfi®

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

Group Type ACTIVE_COMPARATOR

MenACYW conjugate vaccine

Intervention Type BIOLOGICAL

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

Placebo

Intervention Type BIOLOGICAL

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

Group 6: Sanofi MenB

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

Group Type EXPERIMENTAL

Meningococcal group B vaccine

Intervention Type BIOLOGICAL

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

Placebo

Intervention Type BIOLOGICAL

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

Group 7: PENBRAYA

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

Group Type ACTIVE_COMPARATOR

MenABCYW conjugate vaccine

Intervention Type BIOLOGICAL

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

Interventions

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Pentavalent Meningococcal ABCYW vaccine

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

Intervention Type BIOLOGICAL

MenACYW conjugate vaccine

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

Intervention Type BIOLOGICAL

Meningococcal group B vaccine

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

Intervention Type BIOLOGICAL

Meningococcal group B vaccine

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

Intervention Type BIOLOGICAL

Meningococcal group B vaccine

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

Intervention Type BIOLOGICAL

MenACYW conjugate vaccine

Pharmaceutical form:Powder and solvent for solution for injection-Route of administration:Intramuscular (IM)

Intervention Type BIOLOGICAL

Placebo

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

Intervention Type BIOLOGICAL

MenABCYW conjugate vaccine

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

Intervention Type BIOLOGICAL

Other Intervention Names

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MenPenta MenQuadFi® Bexsero® Trumenba® Sanofi MenB Menveo® PENBRAYATM

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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.
Minimum Eligible Age

10 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sanofi Pasteur, a Sanofi Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

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

Birmingham, Alabama, United States

Site Status

Lakeview Clinical Research Site Number : 8400029

Guntersville, Alabama, United States

Site Status

Alliance for Multispecialty Research- Phoenix- Site Number : 8400056

Tempe, Arizona, United States

Site Status

Harrisburg Family Medical Center Site Number : 8400070

Harrisburg, Arkansas, United States

Site Status

Smart Cures Clinical Research Site Number : 8400072

Anaheim, California, United States

Site Status

Hope Clinical Research, LLC- Site Number : 8400001

Canoga Park, California, United States

Site Status

Apex Research Group Site Number : 8400071

Fair Oaks, California, United States

Site Status

Velocity Clinical Research-Washington DC Site Number : 8400102

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

Site Status

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

DeLand, Florida, United States

Site Status

SIMEDHealth, LLC- Site Number : 8400045

Gainesville, Florida, United States

Site Status

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

Largo, Florida, United States

Site Status

South Florida Research Organization Site Number : 8400086

Medley, Florida, United States

Site Status

Life Arc Research-Miami Site Number : 8400094

Miami, Florida, United States

Site Status

Charisma Medical and Research center Site Number : 8400097

Miami Lakes, Florida, United States

Site Status

Accel Research - Nona Pediatric Center Site Number : 8400079

Orlando, Florida, United States

Site Status

Ormond Beach Clinical Research- Site Number : 8400073

Ormond Beach, Florida, United States

Site Status

Palm Harbor Dermatology- Site Number : 8400030

Tampa, Florida, United States

Site Status

PAS Research Site Number : 8400032

Tampa, Florida, United States

Site Status

VICIS Clinical Research-Tampa Site Number : 8400065

Tampa, Florida, United States

Site Status

Leavitt Clinical Research-Idaho Falls- Site Number : 8400075

Idaho Falls, Idaho, United States

Site Status

Snake River Research, PLLC- Site Number : 8400100

Idaho Falls, Idaho, United States

Site Status

AES Peoria- Site Number : 8400090

Peoria, Illinois, United States

Site Status

AMR Evansville Site Number : 8400062

Evansville, Indiana, United States

Site Status

AMR - Newton- Site Number : 8400104

Newton, Kansas, United States

Site Status

~Kentucky Pediatics / Adult Research- Site Number : 8400009

Bardstown, Kentucky, United States

Site Status

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

Lexington, Kentucky, United States

Site Status

Vida Clinical Studies Site Number : 8400084

Dearborn Heights, Michigan, United States

Site Status

Vida Clinical Studies- Site Number : 8400084

Dearborn Heights, Michigan, United States

Site Status

Be Well Clinical Studies- Site Number : 8400077

Lincoln, Nebraska, United States

Site Status

Alivation Research (Primary Care) Site Number : 8400046

Lincoln, Nebraska, United States

Site Status

Quality Clinical Research, Inc.- Site Number : 8400074

Omaha, Nebraska, United States

Site Status

Velocity Clinical Research, Omaha- Site Number : 8400066

Omaha, Nebraska, United States

Site Status

Velocity Clinical Research-Albuquerque- Site Number : 8400101

Albuquerque, New Mexico, United States

Site Status

Prime Global Research, Inc. Site Number : 8400043

The Bronx, New York, United States

Site Status

Monroe Biomedical Research - Site Number : 8400099

Monroe, North Carolina, United States

Site Status

SPICA Clinical Research Site Number : 8400098

Columbia, South Carolina, United States

Site Status

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

North Charleston, South Carolina, United States

Site Status

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

Simpsonville, South Carolina, United States

Site Status

Pediatric Clinical Trials Tullahoma- Site Number : 8400020

Tullahoma, Tennessee, United States

Site Status

New Horizon Medical Group-Houston Site Number : 8400069

Houston, Texas, United States

Site Status

DM Clinical Research- Bellaire- Site Number : 8400052

Houston, Texas, United States

Site Status

Advances in Health- Pearland- Site Number : 8400078

Pearland, Texas, United States

Site Status

Be Well Clinical Studies -Round Rock Site Number : 8400053

Round Rock, Texas, United States

Site Status

Progressive Clinical Research- Site Number : 8400028

Bountiful, Utah, United States

Site Status

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

Kaysville, Utah, United States

Site Status

Alliance for Multispecialty Research- Site Number : 8400107

Murray, Utah, United States

Site Status

Investigational Site Number : 6300001

San Juan, , Puerto Rico

Site Status

Countries

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United States Puerto Rico

Related Links

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Other Identifiers

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U1111-1272-6824

Identifier Type: REGISTRY

Identifier Source: secondary_id

2023-000924-13

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

VAN00010

Identifier Type: -

Identifier Source: org_study_id

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