Lot-to-lot Consistency Study of Three Commercial Batches of Enterovirus 71 Vaccine
Recruiting
Phase 4
Interventional Study
Hand, Foot and Mouth Disease
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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.
At a Glance
- Age
- 6 Months – 35 Months
- Sex
- Any
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 1,500 (estimated)
- Sponsor
- Institute of Medical Biology, Chinese Academy of Medical Sciences · Other
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About This Trial
This study is a randomized, blinded study to evaluate the lot-to-lot consistency of immunogenicity, safety, and immune persistence of three consecutive manufacturing lots of EV71 vaccine, in 1500 children aged 6-35 months. The primary immunogenicity endpoint is the anti-EV71 neutralizing antibody geometric mean titer (GMT) 30 days after the final dose. The secondary immunogenicity endpoints are th…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Age Requirement: Children aged 6 to 35 months at the time of enrollment.
* Provision of legal Identification: Volunteers and their legal guardians or appointed representatives must provide valid legal identification documents.
* Informed Consent: Legal guardians or appointed r…
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