Phase Ⅲ Trial of Group ACYW135 Meningococcal Conjugate Vaccine in Children Aged 6-11 Months

Recruiting Phase 3 Interventional Study
Epidemic Meningitis Meningococcal Vaccines
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial. Healthy Volunteers Welcome You do not need to have the condition being studied to take part.
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At a Glance
Age
6 Months – 11 Months
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Prevention
Participants needed
1,040 (estimated)
Sponsor
Sinovac Biotech Co., Ltd · Industry
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About This Trial
The goal of this clinical trial is to evaluate the immunogenicity, safety, and persistence of the immune response of a group ACYW135 meningococcal conjugate vaccine in healthy children aged 6 to 11 months. The main questions it aims to answer are: Is the immune response induced by the investigational vaccine non-inferior to that of the licensed control vaccine following the primary series? What …
Trial Locations
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Eligibility 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. P…
Contacts

Yi Mo

0771-2518766

cngxcdc@163.com

CONTACT