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

Sanofi Pasteur, a Sanofi Company1,215 enrolled

Overview

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.

The study duration will be approximately 12 months for all participants

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

1,215

Conditions

Meningococcal Immunisation Healthy Volunteers

Interventions

Pentavalent Meningococcal ABCYW vaccineBIOLOGICAL

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

MenACYW conjugate vaccineBIOLOGICAL

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

Meningococcal group B vaccineBIOLOGICAL

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

Eligibility

Sex: ALLMin age: 10 YearsMax age: 25 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (47)

Outcomes

Primary Outcomes

Number of participants with immediate adverse events (AEs)

Unsolicited systemic AEs that occur within 30 minutes after vaccination

Time frame: 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

Time frame: Within 7 days after each vaccination

Number of participants with unsolicited AEs

Non-serious AEs other than solicited reactions

Time frame: 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

Time frame: 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

Time frame: From baseline up to 12 months

Number of participants with out-of-range biological test results

Time frame: 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)

Data from ClinicalTrials.gov

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Secondary Outcomes

hSBA meningococcal serogroups A, C, W, and Y vaccine seroresponse at each timepoint

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)

Time frame: 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

hSBA titers ≥ 1:8 post-vaccination

Geometric mean titers (GMTs) of Antibodies against Meningococcal Serogroups A, C, W and Y at each timepoint

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

hSBA meningococcal serogroup B (reference MenB strains) vaccine seroresponse at each timepoint

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

hSBA titers ≥ 1:4 for reference MenB strains

Percentage of Participants With Meningococcal Antibody Titers against meningococcal serogroup B (reference MenB strains) ≥ 1:8 at each timepoint

hSBA titers ≥ 1:8 reference MenB strains

Geometric mean titers (GMTs) of Antibodies against Meningococcal Serogroup B (reference MenB strains) at each timepoint

Geometric mean titers for reference MenB strains

Percentage of participants with hSBA composite seroresponse titers more or equal to LLOQ for reference MenB strains for each timepoint

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

Seroresponse defined as a 4-fold increase in hSBA titers from D01 to post-vaccination for reference and additional MenB strains

Time frame: 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)

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

hSBA titers ≥ 1:4 for reference and additional MenB strains

Time frame: 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)

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

hSBA titers ≥ 1:8 for reference and additional MenB strains

Time frame: 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 (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

Geometric mean titers for reference and additional MenB strains

Time frame: 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)

Percentage of participants with hSBA composite seroresponse titers more or equal to LLOQ reference and additional MenB strains in adolescent participants

Time frame: 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

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)