💬In plain words
What the trial is, and whether it could suit you
The goal of this clinical trial is to evaluate the immunogenicity, safety, and immune persistence of the primary series of an investigational group ACYW135 meningococcal conjugate vaccine, as well as the immunogenicity and safety of a booster dose administered at 12 months of age, in healthy children aged 3 to 5 months.
The main questions it aims to answer are:
Is the immune response induced by the primary series of the investigational vaccine non-inferior to that of the licensed control vaccine? What is the safety profile of the investigational vaccine during the primary series and booster dose? Does the investigational vaccine provide immune persistence up to 12 months of age? What is the immunogenicity of a booster dose administered at 12 months of age? Researchers will compare the investigational vaccine group with the active comparator group (CanSinoBIO MCV-ACYW) during both the p
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📋 Eligibility rules (as published)
Inclusion Criteria:
1. Healthy participants aged 3 to 5 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 meningococcal polysaccharide vaccine, Group A/C meningococcal polysaccharide/conjugate vaccine, ACYW135 meningococcal polysaccharide/conjugate 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), current perianal abscess, or severe eczema.
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 persistent disease conditions 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. Newborn gestational age \<37 weeks or ≥42 weeks.
9. Birth weight \<2500g or \>4000g, or history of difficult birth, resuscitation at birth, or neurological damage.
10. Presence of or history of severe neurological disorders \[epilepsy, convulsions or seizures\], or family history of psychiatric disorders.
11. Receipt of immunoglobulins or other blood products within the past 3 months, or planned receipt of such treatments during the study period.
12. Prior 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, or planned receipt of such therapies during the study period.
13. Receipt of any other investigational drug or vaccine within the past 3 months, or planned receipt during the study period.
14. Receipt of a live attenuated vaccine within the past 14 days, or receipt of a subunit or inactivated vaccine within the past 7 days.
15. 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.
16. Acute illness or acute exacerbation of persistent disease conditions within the past 3 days, or known or suspected active infection.
17. Fever (axillary temperature \>37.0°C) on the day of scheduled study vaccination, or abnormal findings on physical examination that preclude vaccination.
18. Skin lesions, inflammation, ulcers, rash, or scarring at the intended injection site that may interfere with vaccination or local reaction assessment.
19. Any other condition that, in the investigator's judgment, makes the participant unsuitable for participation in this clinical trial.
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