Clinical trial Recruiting at 2 sites Phase 3 Interventional Ages 6 Months to 11 Months

Group ACYW135 meningococcal vaccine in children 6-11 months

Official title: A Randomized, Double-Blind, Active Comparator-Controlled Phase Ⅲ Trial to Evaluate the Immunogenicity and Safety of the Group ACYW135 Meningococcal Conjugate Vaccine in Population Aged 6 to 11 Months

Run by Sinovac Biotech Co., Ltd · NCT07505823 · Data updated 2026-11-12

This trial tests whether the investigational meningococcal vaccine in healthy infants aged 6 to 11 months can provoke a strong immune response with good safety compared with a licensed vaccine.

More Epidemic Meningitis trials

Quick facts

PhasePhase 3
Study typeInterventional
Ages6 Months to 11 Months
SexAll
Enrollment1040 (estimated)
SponsorSinovac Biotech Co., Ltd
Industry-sponsored
Drugs / interventionsprednisone
Locations2 sites (Nanning, Guangxi and 1 other locations)
StatusRecruiting
StartedMarch 22, 2026
Main results expectedApril 2027
Study endsJanuary 2028
Registry record updatedAugust 10, 2026
Trial IDNCT07505823 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Healthy infants aged 6 to 11 months whose guardians provide informed consent and are able to comply with study visits.

Probably not a fit

Infants with a history or suspicion of meningococcal disease, certain vaccine allergies, or prior meningococcal vaccination may not benefit.

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, randomized, active-controlled trial compares a group ACYW135 meningococcal conjugate vaccine against a licensed ACYW135 vaccine in healthy infants 6 to 11 months old. Participants receive the primary immunization series and are evaluated for non-inferiority of immune response, safety during the initial series and booster, and immune persistence to 18 months, with a booster at 18 months to assess booster immunogenicity. The study uses an active comparator to establish how the investigational vaccine performs relative to the licensed product. Immunogenicity is assessed through antibody responses, and safety data are collected throughout the vaccination schedule and follow-up visits. The trial is conducted at CDC-affiliated centers in Guangxi and Shanxi, China, led by Sinovac Biotech Co., Ltd.

Why it matters

Potential benefit: If successful, the investigational vaccine could provide another effective option for protecting infants against meningococcal disease.

How similar studies have gone: Prior meningococcal vaccine studies support the feasibility of evaluating non-inferiority and booster immunogenicity, though this exact ACYW135 formulation is under investigation.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

1. Healthy participants aged 6 to 11 months.
2. The participant's legal guardian is capable of understanding and voluntarily signs the informed consent form.
3. Willing and able to comply with all scheduled visits, sample collection, vaccination, and other trial procedures.
4. Provision of legal identification documentation.

Exclusion Criteria:

1. History (or suspected history) of meningococcal disease.
2. History of infantile wheezing; history of allergy to the vaccine or any vaccine components (Group A/C/Y/W135 meningococcal capsular polysaccharide, mannitol, sucrose, sodium dihydrogen phosphate monohydrate, disodium hydrogen phosphate dodecahydrate, sodium chloride, water for injection), such as urticaria, dyspnea, angioedema; or other serious adverse reactions following prior vaccination.
3. Prior vaccination with any meningococcal vaccine (including but not limited to: Group A/C meningococcal polysaccharide/conjugate vaccine, ACYW135 meningococcal polysaccharide/conjugate vaccine, Group A meningococcal polysaccharide vaccine, etc.).
4. Presence of autoimmune diseases, immunodeficiency diseases (including but not limited to asplenia, functional asplenia, HIV infection in the participant or the participant's mother), or current perianal abscess.
5. Coagulation disorders (e.g., coagulation factor deficiency, platelet abnormalities) or history of significant bleeding, hematoma, or ecchymosis following intramuscular injection or venipuncture.
6. Presence of poorly controlled chronic diseases or history of serious illnesses, including but not limited to cardiovascular diseases, hematological diseases, hepatorenal diseases, gastrointestinal diseases, respiratory diseases, malignancies, or history of major organ transplantation.
7. Severe congenital anomalies, genetic defects, or malnutrition.
8. Presence of or history of severe neurological disorders \[epilepsy, convulsions or seizures\], or family history of psychiatric disorders.
9. Receipt of immunoglobulins or other blood products within the past 3 months, or planned receipt of such treatments during the study period.
10. Receipt of immunosuppressants or other immunomodulatory therapy for ≥14 days (e.g., prednisone ≥20 mg/day or ≥2 mg/kg/day, or equivalent), cytotoxic therapy within the past 6 months, or planned receipt of such therapies during the study period.
11. Receipt of any other investigational drug or vaccine within the past 3 months, or planned receipt during the study period.
12. Receipt of a live attenuated vaccine within the past 14 days, or receipt of a subunit or inactivated vaccine within the past 7 days.
13. Receipt of any other licensed vaccine within the past 28 days where administration at a different injection site from the study vaccine cannot be ensured.
14. Acute illness or acute exacerbation of chronic disease within the past 3 days, or known or suspected active infection.
15. Fever (axillary temperature \>37.0°C) on the day of scheduled study vaccination, or abnormal findings on physical examination that preclude vaccination.
16. Skin lesions, inflammation, ulcers, rash, or scarring at the intended injection site that may interfere with vaccination or local reaction assessment.
17. Any other condition that, in the investigator's judgment, makes the participant unsuitable for participation in this clinical trial.

Where it's running

  • Guangxi Zhuang Autonomous Region Center for Disease Control and Prevention
    Nanning, Guangxi, China
    Recruiting
  • Shanxi Provincial Center for Disease Control and Prevention
    Taiyuan, Shanxi, China
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

  • Meningococcal vaccine for children 12–23 months old (Group ACYW135)

    This study tests whether the new Group ACYW135 meningococcal vaccine in healthy children aged 12 to 23 months can provoke a similar immune response and has an acceptable safety profile compared with a licensed vaccine.

    Recruiting at 2 sites Phase 3 Sinovac Biotech Co., Ltd · Nanning, Guangxi and 1 other locations · NCT07505836

  • Meningococcal vaccine in infants aged 3-5 months

    This trial tests a new group ACYW135 meningococcal vaccine in healthy babies aged 3 to 5 months to see if it triggers a strong immune response and how safe it is, with a booster given at 12 months.

    Recruiting at 2 sites Phase 3 Sinovac Biotech Co., Ltd · Nanning, Guangxi and 1 other locations · NCT07505810

  • Combined DTaP-Hib and Meningococcal ACYW135 vaccine for infants and children

    This trial tests a combined vaccine that protects against diphtheria, tetanus, pertussis, Haemophilus influenzae type b, and meningococcal ACYW135 in children aged 2 months to 6 years to see if it is safe and prompts an immune response.

    Recruiting Phase 1 CanSino Biologics Inc. · Shangqiu, Henan · NCT07203755

  • National survey on bacterial meningitis in children

    This study is trying to learn more about bacterial meningitis in children by looking at which bacteria are causing it and how things have changed since the introduction of vaccines.

    Recruiting Association Clinique Thérapeutique Infantile du val de Marne · Créteil · NCT04664569

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.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.