Study of an Investigational Pentavalent Meningococcal ABCYW Vaccine in Adults and Adolescents
- Conditions
- Meningococcal ImmunisationHealthy Volunteers
- Interventions
- Biological: Pentavalent Meningococcal ABCYW vaccineBiological: MenABCYW conjugate vaccineBiological: Placebo
- 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
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 1220
- 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
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 4: Trumenba® + Menveo® Meningococcal group B vaccine Participants (ACWY naive and primed adults or adolescents) will receive injections of Trumenba® + Menveo® vaccine 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 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 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 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 5: MenQuadfi® Placebo Participants (ACWY naive and primed adults or adolescents) will receive injections of MenQuadfi® vaccine and placebo Group 7: PENBRAYA MenABCYW conjugate vaccine Participants (ACWY naive and primed adults or adolescents) will receive injections of PENBRAYA 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 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 Placebo Participants (ACWY naive and primed adults or adolescents) will receive injections of the pentavalent meningococcal ABCYW 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 5: MenQuadfi® MenACYW conjugate vaccine Participants (ACWY naive and primed adults or adolescents) will receive injections of MenQuadfi® 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 immediate adverse events (AEs) Within 30 minutes after each vaccination Unsolicited systemic AEs that occur within 30 minutes after vaccination
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)
- 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
Alliance for Multispecialty Research- Phoenix- Site Number : 8400056
🇺🇸Tempe, Arizona, United States
Hope Clinical Research, LLC- Site Number : 8400001
🇺🇸Canoga Park, California, United States
SIMEDHealth, LLC- Site Number : 8400045
🇺🇸Gainesville, Florida, United States
Accel Clinical Research-Deland Clinical Research Unit- Site Number : 8400081
🇺🇸DeLand, Florida, United States
Accel Research Sites-St. Petersburg-Largo- Site Number : 8400082
🇺🇸Largo, Florida, United States
Life Arc Research-Miami Site Number : 8400094
🇺🇸Miami, Florida, United States
AES Peoria- Site Number : 8400090
🇺🇸Peoria, Illinois, United States
AMR - Newton- Site Number : 8400104
🇺🇸Newton, Kansas, United States
Vida Clinical Studies- Site Number : 8400084
🇺🇸Dearborn Heights, Michigan, United States
Quality Clinical Research, Inc.- Site Number : 8400074
🇺🇸Omaha, Nebraska, United States
Monroe Biomedical Research - Site Number : 8400099
🇺🇸Monroe, North Carolina, United States
AMR Utah-Wee Care Pediatrics-Kaysville- Site Number : 8400106
🇺🇸Kaysville, Utah, United States
Ormond Beach Clinical Research- Site Number : 8400073
🇺🇸Ormond Beach, Florida, United States
Leavitt Clinical Research-Idaho Falls- Site Number : 8400075
🇺🇸Idaho Falls, Idaho, United States
Palm Harbor Dermatology- Site Number : 8400030
🇺🇸Tampa, Florida, United States
Michael W. Simon, MD, PSC- Site Number : 8400026
🇺🇸Lexington, Kentucky, United States
Snake River Research, PLLC- Site Number : 8400100
🇺🇸Idaho Falls, Idaho, United States
~Kentucky Pediatics / Adult Research- Site Number : 8400009
🇺🇸Bardstown, Kentucky, United States
Be Well Clinical Studies- Site Number : 8400077
🇺🇸Lincoln, Nebraska, United States
Coastal Carolina Research Center - N Charleston- Site Number : 8400050
🇺🇸North Charleston, South Carolina, United States
Harrisburg Family Medical Center Site Number : 8400070
🇺🇸Harrisburg, Arkansas, United States
South Florida Research Organization Site Number : 8400086
🇺🇸Medley, Florida, United States
Accel Research - Nona Pediatric Center Site Number : 8400079
🇺🇸Orlando, Florida, 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
DM Clinical Research- Bellaire- Site Number : 8400052
🇺🇸Houston, Texas, United States
Advances in Health- Pearland- Site Number : 8400078
🇺🇸Pearland, Texas, United States
Alliance for Multispecialty Research- Site Number : 8400107
🇺🇸Murray, Utah, United States
Lakeview Clinical Research Site Number : 8400029
🇺🇸Guntersville, Alabama, United States
Apex Research Group Site Number : 8400071
🇺🇸Fair Oaks, California, United States
Velocity Clinical Research-Washington DC Site Number : 8400102
🇺🇸Washington, District of Columbia, United States
AMR Evansville Site Number : 8400062
🇺🇸Evansville, Indiana, United States
Vida Clinical Studies Site Number : 8400084
🇺🇸Dearborn Heights, Michigan, United States
Prime Global Research, Inc. Site Number : 8400043
🇺🇸Bronx, New York, United States
SPICA Clinical Research Site Number : 8400098
🇺🇸Columbia, South Carolina, United States
Pediatric Clinical Trials Tullahoma- Site Number : 8400020
🇺🇸Tullahoma, Tennessee, United States
Progressive Clinical Research- Site Number : 8400028
🇺🇸Bountiful, Utah, United States
Smart Cures Clinical Research Site Number : 8400072
🇺🇸Anaheim, California, United States
PAS Research Site Number : 8400032
🇺🇸Tampa, Florida, United States
VICIS Clinical Research-Tampa Site Number : 8400065
🇺🇸Tampa, Florida, United States
Alivation Research (Primary Care) Site Number : 8400046
🇺🇸Lincoln, Nebraska, United States
Charisma Medical and Research center Site Number : 8400097
🇺🇸Miami Lakes, Florida, United States
Tribe Clinical Research at Parkside Pediatrics-Five Forks Site Number : 8400049
🇺🇸Simpsonville, South Carolina, United States
New Horizon Medical Group-Houston Site Number : 8400069
🇺🇸Houston, Texas, United States
Be Well Clinical Studies -Round Rock Site Number : 8400053
🇺🇸Round Rock, Texas, United States
Investigational Site Number : 6300001
🇵🇷San Juan, Puerto Rico