Clinical trial NCT06128733: Study of an Investigational Pentavalent Meningococcal ABCYW Vaccine in Adults and Adolescents
Official title: A Phase I/II, Randomized, Descriptive, Safety and Immunogenicity Study to Assess Pentavalent Meningococcal ABCYW Vaccine Formulations in Adults (18 to 25 Years of Age) and Adolescents (10 to 17 Years of Age).
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Meningococcal Immunisation
Healthy Volunteers
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2023-11-13
Enrollment: 1220
Sex: ALL
Minimum age (years): 10
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants with immediate adverse events (AEs)
timeFrame: Within 30 minutes after each vaccination
measure: Number of participants with solicited injection site reactions or systemic reactions
timeFrame: Within 7 days after each vaccination
measure: Number of participants with unsolicited AEs
timeFrame: Within 30 days after each vaccination
measure: Number of participants with serious adverse events (SAEs)
timeFrame: From baseline up to 12 months
measure: Number of participants with medically attended adverse events (MAAEs)
timeFrame: From baseline up to 12 months
measure: Number of participants with out-of-range biological test results
timeFrame: 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
measure: hSBA meningococcal serogroups A, C, W, and Y vaccine seroresponse pre-dose and 1 month after the second dose in adolescent participants
timeFrame: Day 01 (pre-dose) and Day 211 (for Group 1 to 7)
measure: hSBA meningococcal serogroups A, C, W, and Y antibody titers pre-dose and 1 month after the second dose in adolescent participants
timeFrame: Day 211 (for Group 1 to 7)
measure: 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
timeFrame: Day 01 (pre-dose) and Day 31 Day 211 (for Group 1 to 7)
measure: 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
timeFrame: Day 01 (pre-dose) Day 211 (for Group 1 to 7)
measure: hSBA meningococcal serogroup B seroresponse pre-dose and 1 month after second dose in adolescent participants
timeFrame: Day 01 (pre-dose) and Day 211 (for Group 1 to 7)
measure: 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
timeFrame: Day 01 (pre-dose) and Day 211 (for Group 1 to 7)
measure: 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
timeFrame: Day 01 (pre-dose) and Day 211 (for Group 1 to 7)
measure: 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
timeFrame: Day 01 (pre-dose) and Day 211 (for Group 1 to 7)
measure: 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
timeFrame: Day 01 (pre-dose) and Day 211 (for Group 1 to 7)
Secondary outcomes:
measure: hSBA meningococcal serogroups A, C, W, and Y vaccine seroresponse at each timepoint
timeFrame: 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)
measure: hSBA meningococcal serogroups A, C, W, and Y antibody titers at each timepoint
timeFrame: 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)
measure: Geometric mean titers (GMTs) of Antibodies against Meningococcal Serogroups A, C, W and Y at each timepoint
timeFrame: 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)
measure: Percentage of participants with hSBA titers more or equal to LLOQ against each of serogroups A, C, W, and Y at each timepoint
timeFrame: 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)
measure: hSBA meningococcal serogroup B (reference MenB strains) vaccine seroresponse at each timepoint
timeFrame: 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)
measure: Percentage of Participants With Meningococcal Antibody Titers against meningococcal serogroup B (reference MenB strains) ≥ 1:4 at each timepoint
timeFrame: 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)
measure: Percentage of Participants With Meningococcal Antibody Titers against meningococcal serogroup B (reference MenB strains) ≥ 1:8 at each timepoint
timeFrame: 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)
measure: Geometric mean titers (GMTs) of Antibodies against Meningococcal Serogroup B (reference MenB strains) at each timepoint
timeFrame: 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)
measure: Percentage of participants with hSBA composite seroresponse titers more or equal to LLOQ for reference MenB strains for each timepoint
timeFrame: 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)
measure: 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
timeFrame: 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)
measure: 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
timeFrame: 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)
measure: 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
timeFrame: 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)
measure: 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
timeFrame: 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)
measure: Percentage of participants with hSBA composite seroresponse titers more or equal to LLOQ reference and additional MenB strains in adolescent participants
timeFrame: 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)
measure: hSBA meningococcal serogroups A, C, W, and Y vaccine seroresponse 1 month after the third dose in adult participants
timeFrame: Day 01 (pre-dose) and Day 211 (for Group 1 to 6)
measure: hSBA meningococcal serogroups A, C, W, and Y antibody titers pre-dose and 1 month after the third dose in adult participants
timeFrame: Day 01 (pre-dose) and Day 211 (for Group 1 to 6)
measure: 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
timeFrame: Day 01 (pre-dose) and Day 211 (for Group 1 to 6)
measure: Percentage of participants with hSBA titers more or equal to LLOQ against each of serogroups A, C, W, and Y in adult participants
timeFrame: Day 01 (pre-dose) and Day 211 (for Group 1 to 6)
measure: hSBA meningococcal serogroup B (reference MenB strains) seroresponse pre-dose and 1 month after third dose in adult participants
timeFrame: Day 01 (pre-dose) and Day 211 (for Group 1 to 6)
measure: 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
timeFrame: Day 01 (pre-dose) and Day 211 (for Group 1 to 6)
measure: 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
timeFrame: Day 01 (pre-dose) and Day 211 (for Group 1 to 6)
measure: 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
timeFrame: Day 01 (pre-dose) and Day 211 (for Group 1 to 6)
measure: 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
timeFrame: Day 01 (pre-dose) and Day 211 (for Group 1 to 6)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Accel Research Site - Birmingham Clinical Research Unit- Site Number : 8400080
state: Alabama
city: Guntersville
country: United States
facility: Lakeview Clinical Research Site Number : 8400029
state: Alabama
city: Tempe
country: United States
facility: Alliance for Multispecialty Research- Phoenix- Site Number : 8400056
state: Arizona
city: Harrisburg
country: United States
facility: Harrisburg Family Medical Center Site Number : 8400070
state: Arkansas
city: Anaheim
country: United States
facility: Smart Cures Clinical Research Site Number : 8400072
state: California
city: Canoga Park
country: United States
facility: Hope Clinical Research, LLC- Site Number : 8400001
state: California
city: Fair Oaks
country: United States
facility: Apex Research Group Site Number : 8400071
state: California
city: Washington
country: United States
facility: Velocity Clinical Research-Washington DC Site Number : 8400102
state: District of Columbia
city: DeLand
country: United States
facility: Accel Clinical Research-Deland Clinical Research Unit- Site Number : 8400081
state: Florida
city: Gainesville
country: United States
facility: SIMEDHealth, LLC- Site Number : 8400045
state: Florida
city: Largo
country: United States
facility: Accel Research Sites-St. Petersburg-Largo- Site Number : 8400082
state: Florida
city: Medley
country: United States
facility: South Florida Research Organization Site Number : 8400086
state: Florida
city: Miami Lakes
country: United States
facility: Charisma Medical and Research center Site Number : 8400097
state: Florida
city: Miami
country: United States
facility: Life Arc Research-Miami Site Number : 8400094
state: Florida
city: Orlando
country: United States
facility: Accel Research - Nona Pediatric Center Site Number : 8400079
state: Florida
city: Ormond Beach
country: United States
facility: Ormond Beach Clinical Research- Site Number : 8400073
state: Florida
city: Tampa
country: United States
facility: Palm Harbor Dermatology- Site Number : 8400030
state: Florida
city: Tampa
country: United States
facility: PAS Research Site Number : 8400032
state: Florida
city: Tampa
country: United States
facility: VICIS Clinical Research-Tampa Site Number : 8400065
state: Florida
city: Idaho Falls
country: United States
facility: Leavitt Clinical Research-Idaho Falls- Site Number : 8400075
state: Idaho
city: Idaho Falls
country: United States
facility: Snake River Research, PLLC- Site Number : 8400100
state: Idaho
city: Peoria
country: United States
facility: AES Peoria- Site Number : 8400090
state: Illinois
city: Evansville
country: United States
facility: AMR Evansville Site Number : 8400062
state: Indiana
city: Newton
country: United States
facility: AMR - Newton- Site Number : 8400104
state: Kansas
city: Bardstown
country: United States
facility: ~Kentucky Pediatics / Adult Research- Site Number : 8400009
state: Kentucky
city: Lexington
country: United States
facility: Michael W. Simon, MD, PSC- Site Number : 8400026
state: Kentucky
city: Dearborn Heights
country: United States
facility: Vida Clinical Studies Site Number : 8400084
state: Michigan
city: Dearborn Heights
country: United States
facility: Vida Clinical Studies- Site Number : 8400084
state: Michigan
city: Lincoln
country: United States
facility: Be Well Clinical Studies- Site Number : 8400077
state: Nebraska
city: Lincoln
country: United States
facility: Alivation Research (Primary Care) Site Number : 8400046
state: Nebraska
city: Omaha
country: United States
facility: Quality Clinical Research, Inc.- Site Number : 8400074
state: Nebraska
city: Omaha
country: United States
facility: Velocity Clinical Research, Omaha- Site Number : 8400066
state: Nebraska
city: Albuquerque
country: United States
facility: Velocity Clinical Research-Albuquerque- Site Number : 8400101
state: New Mexico
city: Bronx
country: United States
facility: Prime Global Research, Inc. Site Number : 8400043
state: New York
city: Monroe
country: United States
facility: Monroe Biomedical Research - Site Number : 8400099
state: North Carolina
city: Columbia
country: United States
facility: SPICA Clinical Research Site Number : 8400098
state: South Carolina
city: North Charleston
country: United States
facility: Coastal Carolina Research Center - N Charleston- Site Number : 8400050
state: South Carolina
city: Simpsonville
country: United States
facility: Tribe Clinical Research at Parkside Pediatrics-Five Forks Site Number : 8400049
state: South Carolina
city: Tullahoma
country: United States
facility: Pediatric Clinical Trials Tullahoma- Site Number : 8400020
state: Tennessee
city: Houston
country: United States
facility: New Horizon Medical Group-Houston Site Number : 8400069
state: Texas
city: Houston
country: United States
facility: DM Clinical Research- Bellaire- Site Number : 8400052
state: Texas
city: Pearland
country: United States
facility: Advances in Health- Pearland- Site Number : 8400078
state: Texas
city: Round Rock
country: United States
facility: Be Well Clinical Studies -Round Rock Site Number : 8400053
state: Texas
city: Bountiful
country: United States
facility: Progressive Clinical Research- Site Number : 8400028
state: Utah
city: Kaysville
country: United States
facility: AMR Utah-Wee Care Pediatrics-Kaysville- Site Number : 8400106
state: Utah
city: Murray
country: United States
facility: Alliance for Multispecialty Research- Site Number : 8400107
state: Utah
city: San Juan
country: Puerto Rico
facility: Investigational Site Number : 6300001
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: