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Completed
NCT07635966
An Extension Study of EV-BR1701 Part A1
Conditions: Enterovirus Infections
Sex: All
Ages: 86 Months – 14 Years
Healthy volunteers: No
Enrollment: 180
Sponsor: Enimmune Corporation
Location: National Taiwan University Hospital HsinChu Branch Hsinchu
Summary
To determine the long-term immunogenicity more than 5 years after EnVAX-A71 vaccination in the pediatric population aged 2 months to \
Eligibility Criteria
Inclusion Criteria:
1. Healthy children who were enrolled in Part A1 (immunogenicity sub-study) of EV-BR1701, received two injections of either EnVAX-A71 or placebo, and had blood sample collected on Day 56 for primary immunogenicity endpoint analysis (the "evaluable" subjects).
2. The subject's guardian/legal representative is able and willing to comply with study procedures and provide signed informed consent.
Exclusion Criteria:
1. History of bleeding disorder, hemostatic difficulties or significant bruising caused by phlebotomy since the last visit in EV-BR1701 main study.
2. Having been vaccinated with any EV71 vaccine products.
Source: ClinicalTrials.gov (NCT07635966). StuddyBuddy aggregates publicly available trial information.
