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Active (not recruiting) Phase 3 NCT07135986

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

Phase 3 – large-scale trial before approval
Conditions: Meningococcal Infection Healthy Volunteers

Sponsor: Sanofi

trial.available_in: БГ
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.
Description
The duration of each participant's participation will be approximately 180 days.
Who can participate
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.
Interventions
MenACYW conjugate vaccine
BIOLOGICAL
MenACYW135 polysaccharide vaccine
BIOLOGICAL
MenAC conjugate vaccine
BIOLOGICAL
Locations 4
China (4)
Investigational Site Number : 1561001
Jingxi
Investigational Site Number : 1561003
Liuchow
Investigational Site Number : 1561000
Nanning , Guangxi
Investigational Site Number : 1561002
Tengzhou
Technical details
Status
Active (not recruiting)
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
2 Years
Maximum age
17 Years
Healthy volunteers
No
Start date
26.09.2025
Completion date
23.09.2026
Registry ID
NCT07135986
Source
clinicaltrials.gov
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