Is its immune response and safety in babies and toddlers when given a meningococcal vaccine in China

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 interventional trial compares the immunogenicity and safety of MenACYW conjugate vaccine with locally licensed meningococcal vaccines in healthy Chinese infants and toddlers. Participants receive two-dose vaccination in defined cohorts with follow-up safety checks and periodic blood samples to measure immune response. The study includes multiple age-defined cohorts, maternal consent, and predefined safety monitoring, with visits and telephone follow-ups after each vaccination. Lead sponsor is Sanofi, with participating sites in Huanggang, Jianli/Jingzhou, and Jingxi.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* For Cohort I: Aged 12 months through 23 months on the day of inclusion. For Cohort II: Aged 6 months through 11 months on the day of inclusion. For Cohort III: Aged 2 months through 5 months on the day of inclusion
* Born at full term of pregnancy (≥37 weeks) or born after a gestation period of 27 through 36 weeks and medically stable as assessed by the investigator
* Informed consent form has been signed and dated by the parent(s) or other LAR (and by an independent witness if required by local regulations).
* Participant and parent/LAR are able to attend all scheduled visits and to comply with all study procedures.

Exclusion Criteria:

* 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 neurological 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 study
* Known systemic hypersensitivity to any of the study intervention components, or history of a life-threatening reaction to the study interventions used in the study or to a product containing any of the same substances
* Self-reported thrombocytopenia, contraindicating intramuscular injection
* Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular injection
* Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion
* Moderate or severe acute illness/infection (according to investigator judgment) or febrile illness (axillary temperature ≥37.5°C \[99.5℉\]) on the day of study intervention administration. A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided.
* Receipt of any live vaccines within 14 days preceding the trial vaccination or planned receipt of any live vaccines in 14 days following trial vaccination, and receipt of any inactivated vaccines in 8 days preceding the trial vaccination or planned receipt of any live vaccines in 8 days following trial vaccination
* For Cohort I (12 to 23 MoA): receipt of any other meningococcal vaccine except the meningococcal group A polysaccharide vaccine included in the NIP. The time since last vaccination of meningococcal group A or groups A and C polysaccharide vaccine of 6 months or less should be excluded.
* For Cohorts II (6 to 11 MoA) and III (2 to 5 MoA): a vaccination history of any meningococcal vaccine.
* 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.
* Participation at the time of study enrollment (or in the 4 weeks preceding the study intervention administration) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure.
* In an emergency setting, or being hospitalized
* Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Where it's running

• Investigational Site Number : 1563001
  Huanggang, China Recruiting
• Investigational Site Number : 1563003
  Jianli City, Jingzhou City, China Recruiting
• Investigational Site Number : 1561001
  Jingxi, China Recruiting
• Investigational Site Number : 1561003
  Liuzhou, China Recruiting
• Investigational Site Number : 1561000
  Nanning, China Recruiting
• Investigational Site Number : 1561002
  Tengzhou Town, China Recruiting

Study contacts

• Study coordinator: Trial Transparency email recommended (Toll free for US & Canada)
• Email: Contact-US@sanofi.com
• Phone: 800-633-1610

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.