Immunogenicity and Safety Study of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered in Healthy Children and Adolescents in China

Phase 3RecruitingNCT07135986

Sanofi1,602 enrolled

Overview

This is a Phase 3, modified double-blind, randomized, parallel-group, active-controlled, multicenter study with 2 arms and 4 groups to evaluate the immunogenicity and safety of MenACYW conjugate vaccine in children and adolescents versus control meningococcal vaccines licensed in China. Study details include: * The study duration will be approximately 180 days. * The vaccination visit will be Visit 1. * The visit frequency will be 2 on-site visits with a 30-day interval. A safety visit/telephone call is planned on the ninth day after the vaccination for all groups; a safety follow-up telephone call is planned for all groups 180 days post the last vaccination.

The duration of each participant's participation will be approximately 180 days.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

1,602

Conditions

Meningococcal Infection Healthy Volunteers

Interventions

Eligibility

Sex: ALLMin age: 2 YearsMax age: 17 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * For Cohort I: Aged 7 to 17 years on the day of inclusion ("7 to 17 years" means from the day of the 7th birthday to the day before the 18th birthday.). For Cohort II: Aged 2 to 6 years on the day of inclusion (2 to 6 years" means from the day of the 2nd birthday to the day before the 7th birthday.) * Participants who are healthy as determined by medical evaluation including medical history and physical examination. * A female participant is eligible to participate if she is not pregnant or breastfeeding Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply: * Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy; or long-term systemic corticosteroid therapy * History of meningococcal infection * History of any neurologic disorders * History of Guillain-Barré syndrome * History of an Arthus-type hypersensitivity reaction after a previous dose of tetanus toxoid-containing vaccine * At high risk for meningococcal infection during the trial * Known systemic hypersensitivity to any of the vaccine components * Self-reported thrombocytopenia, contraindicating intramuscular vaccination. * Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination. * Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion. * Moderate or severe acute illness/infection * Alcohol, prescription drug, or substance abuse that, in the opinion of the Investigator, might interfere with the study conduct or completion. * Receipt of any vaccine in the 4 weeks preceding the trial vaccination or planned receipt of any vaccine in the 4 weeks following trial vaccination. * The time since last vaccination of meningococcal vaccine was 2 years or less. * Receipt of immune globulins, blood or blood-derived products in the past 3 months. * Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw.

Outcomes

Primary Outcomes

Participants 7 through 17 years of age (Cohort I): Vaccine seroresponse to meningococcal serogroups A, C, Y, and W

30 days postvaccination rSBA titer ≥1:8 for participants with prevaccination rSBA titer \<1:8, or At least 4-fold increase in rSBA titer from pre- to 30 days postvaccination for participants with pre vaccination rSBA titer ≥1:8

Time frame: Day 01 (pre-vaccination) and Day 31 (post- vaccination)

Participants 7 through 17 years of age (Cohort I): Geometric mean titers (GMTs) of antibodies against meningococcal serogroups A, C, Y, and W

Antibodies titers are expressed as geometric mean titers

Time frame: Day 31 (post- vaccination)

Participants 7 through 17 years of age (Cohort I): Vaccine seroresponse to meningococcal serogroups W and Y will be assessed in participants receiving MenACYW conjugate vaccine

30 days postvaccination rSBA titer ≥1:8 for participants with prevaccination rSBA titer \<1:8, or At least 4-fold increase in rSBA titer from pre- to 30 days post-vaccination for participants with pre vaccination rSBA titer ≥1:8

Time frame: Day 01 (pre-vaccination) and Day 31 (post- vaccination)

Participants 2 through 6 years of age (Cohort II): Vaccine seroresponse to meningococcal serogroups A and C

Time frame: Day 01 (pre-vaccination) and Day 31 (post- vaccination)

Participants 2 through 6 years of age (Cohort II): Geometric mean titers (GMTs) of antibodies against meningococcal serogroups A and C

Antibody titers are expressed as geometric mean titers

Time frame: Day 01 (pre-vaccination) and Day 31 (post- vaccination)

Participants 2 through 6 years of age (Cohort II): Vaccine seroresponse to meningococcal serogroups W and Y in participants receiving MenACYW conjugate vaccine

30 days post-vaccination rSBA titer ≥1:8 for participants with pre-vaccination rSBA titer \<1:8, or At least 4-fold increase in rSBA titer from pre- to 30◦days post-vaccination for participants with pre vaccination rSBA titer ≥1:8

Time frame: Day 01 (pre-vaccination) and Day 31 (post- vaccination)

Secondary Outcomes

Number of participants with immediate adverse events (AEs)

Unsolicited systemic AEs that occur within 30 minutes after vaccination

Time frame: Within 30 minutes post-vaccination

Presence of solicited injection site reactions

Solicited injection site reactions include injection site pain, erythema and swelling

Time frame: Within 7 days post-vaccination

Presence of solicited systemic reactions

Solicited systemic reactions include fever, headache, malaise and myalgia

Time frame: Within 7 days post-vaccination

Presence of unsolicited AEs

Time frame: Within 30 days post-vaccination

Presence of SAEs

SAEs, including adverse events of special interest (AESIs), reported throughout the study

Time frame: Up to Day 181 post-vaccination

Participants 7 through 17 years of age (Cohort I): Antibody titers against meningococcal serogroups A, C, Y, and W in Groups 1 and 2

Antibody titers measured by rSBA titer ≥1:8, ≥1:128

Time frame: Day 01 (pre-vaccination) and Day 31 (post- vaccination)

Participants 2 through 6 years of age (Cohort II): Antibody titers against meningococcal serogroups A, C, Y, and W in Group 3 and against meningococcal serogroups A and C in Group 4

Antibody titers measured by rSBA titer ≥1:8, ≥1:128

Time frame: Day 01 (pre-vaccination) and Day 31 (post- vaccination)

Participants 2 through 6 years of age (Cohort II): Antibody titers in terms of GMTs against meningococcal serogroups Y and W in Group 3

Antibodies titers are expressed as geometric mean titers

Immunogenicity and Safety Study of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered in Healthy Children and Adolescents in China

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts