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

NCT07135986

Active Not RecruitingPhase 3

Sponsor: Sanofi

Conditions: Meningococcal Infection, Healthy Volunteers

Interventions: MenACYW conjugate vaccine, MenACYW135 polysaccharide vaccine, MenAC conjugate vaccine

Countries: China

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.

Eligibility overview

Sex: ALL

Age: 2 Years to 17 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria

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.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Locations (4)

Nanning, Guangxi, China
Jingxi, China
Liuzhou, China
Tengzhou, China