Study of an Investigational Pentavalent Meningococcal ABCYW Vaccine in Adults and Adolescents
NCT ID: NCT06128733
Last Updated: 2026-01-13
Study Results
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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COMPLETED
PHASE1/PHASE2
1215 participants
INTERVENTIONAL
2023-10-31
2025-08-27
Brief Summary
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The study duration will be up to 12 months for all participants.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
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
Pentavalent Meningococcal ABCYW vaccine
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular (IM)
Placebo
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
Pentavalent Meningococcal ABCYW vaccine
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular (IM)
Placebo
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
Meningococcal group B vaccine
Pharmaceutical form:Suspension for injection in pre-filled syringe-Route of administration:Intramuscular (IM)
MenACYW conjugate vaccine
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
Meningococcal group B vaccine
Pharmaceutical form:Suspension for injection in pre-filled syringe-Route of administration:Intramuscular (IM)
MenACYW conjugate vaccine
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
MenACYW conjugate vaccine
Pharmaceutical form:Solution for injection in vial-Route of administration:Intramuscular (IM)
Placebo
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
Meningococcal group B vaccine
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular (IM)
Placebo
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
MenABCYW conjugate vaccine
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)
MenACYW conjugate vaccine
Pharmaceutical form:Solution for injection in vial-Route of administration:Intramuscular (IM)
Meningococcal group B vaccine
Pharmaceutical form:Suspension for injection in pre-filled syringe-Route of administration:Intramuscular (IM)
Meningococcal group B vaccine
Pharmaceutical form:Suspension for injection in pre-filled syringe-Route of administration:Intramuscular (IM)
Meningococcal group B vaccine
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular (IM)
MenACYW conjugate vaccine
Pharmaceutical form:Powder and solvent for solution for injection-Route of administration:Intramuscular (IM)
Placebo
Pharmaceutical form:Solution for injection in vial-Route of administration:Intramuscular (IM)
MenABCYW conjugate vaccine
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular (IM)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
10 Years
25 Years
ALL
Yes
Sponsors
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Sanofi Pasteur, a Sanofi Company
INDUSTRY
Responsible Party
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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
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
Accel Research Sites-St. Petersburg-Largo- Site Number : 8400082
Largo, Florida, United States
South Florida Research Organization Site Number : 8400086
Medley, Florida, United States
Life Arc Research-Miami Site Number : 8400094
Miami, Florida, United States
Charisma Medical and Research center Site Number : 8400097
Miami Lakes, Florida, United States
Accel Research - Nona Pediatric Center Site Number : 8400079
Orlando, Florida, United States
Ormond Beach Clinical Research- Site Number : 8400073
Ormond Beach, Florida, United States
Palm Harbor Dermatology- Site Number : 8400030
Tampa, Florida, United States
PAS Research Site Number : 8400032
Tampa, Florida, United States
VICIS Clinical Research-Tampa Site Number : 8400065
Tampa, Florida, United States
Leavitt Clinical Research-Idaho Falls- Site Number : 8400075
Idaho Falls, Idaho, United States
Snake River Research, PLLC- Site Number : 8400100
Idaho Falls, Idaho, United States
AES Peoria- Site Number : 8400090
Peoria, Illinois, United States
AMR Evansville Site Number : 8400062
Evansville, Indiana, United States
AMR - Newton- Site Number : 8400104
Newton, Kansas, United States
~Kentucky Pediatics / Adult Research- Site Number : 8400009
Bardstown, Kentucky, United States
Michael W. Simon, MD, PSC- Site Number : 8400026
Lexington, Kentucky, United States
Vida Clinical Studies Site Number : 8400084
Dearborn Heights, Michigan, United States
Vida Clinical Studies- Site Number : 8400084
Dearborn Heights, Michigan, United States
Be Well Clinical Studies- Site Number : 8400077
Lincoln, Nebraska, United States
Alivation Research (Primary Care) Site Number : 8400046
Lincoln, Nebraska, United States
Quality Clinical Research, Inc.- Site Number : 8400074
Omaha, Nebraska, United States
Velocity Clinical Research, Omaha- Site Number : 8400066
Omaha, Nebraska, United States
Velocity Clinical Research-Albuquerque- Site Number : 8400101
Albuquerque, New Mexico, United States
Prime Global Research, Inc. Site Number : 8400043
The Bronx, New York, United States
Monroe Biomedical Research - Site Number : 8400099
Monroe, North Carolina, United States
SPICA Clinical Research Site Number : 8400098
Columbia, South Carolina, United States
Coastal Carolina Research Center - N Charleston- Site Number : 8400050
North Charleston, South Carolina, United States
Tribe Clinical Research at Parkside Pediatrics-Five Forks Site Number : 8400049
Simpsonville, South Carolina, United States
Pediatric Clinical Trials Tullahoma- Site Number : 8400020
Tullahoma, Tennessee, United States
New Horizon Medical Group-Houston Site Number : 8400069
Houston, Texas, United States
DM Clinical Research- Bellaire- Site Number : 8400052
Houston, Texas, United States
Advances in Health- Pearland- Site Number : 8400078
Pearland, Texas, United States
Be Well Clinical Studies -Round Rock Site Number : 8400053
Round Rock, Texas, United States
Progressive Clinical Research- Site Number : 8400028
Bountiful, Utah, United States
AMR Utah-Wee Care Pediatrics-Kaysville- Site Number : 8400106
Kaysville, Utah, United States
Alliance for Multispecialty Research- Site Number : 8400107
Murray, Utah, United States
Investigational Site Number : 6300001
San Juan, , Puerto Rico
Countries
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Related Links
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VAN00010 Plain Language Results Summary
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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