Clinical Research Directory

Extension Study of Protocol EV-BR1701 Group B1

Sponsor: Enimmune Corporation

Summary

The main study was a randomized, multi-nation, multi-centered, double-blinded, phase III study on subjects aged 2 months to \<6 years old (\<72 months). Two parts were conducted in Taiwan (Group A) and Vietnam (Group B). This extended study involved the subjects enrolled in the EV-BR1701 Group B1 who received any IP injections. For Group B, out of 2727 subjects enrolled from June 2022 to Jul 2023, 241 subjects of Group B1 would be assigned to this extension study. The extension study aimed to evaluate the immunogenicity persistence after EnVAX-A71 vaccination. The subjects of Group B1 would be recalled for phlebotomy and immunogenicity analysis. The subjects would not receive further study EV71 vaccines in the extension study. The principal investigators (PIs) and study coordinators (SCs) of the original medical center would contact the subject's guardians/legal representative by phone to return to the medical center for phlebotomy. Informed consent would be provided to the guardians/legal representative of the subjects, and the eligibility of subjects would be verified on the day of the recall visit. After the subject was evaluated by the PI and meets the phlebotomy requirements, the subject's guardian/legal representative would be asked to sign the informed consent form, and the new subject's number would be given. About 3-4 mL of blood would be collected from each subject, and the serum would be collected and sent to the designated central laboratory for testing. The validated neutralizing antibody (NTAb) analysis method would be used to determine the neutralizing antibody titer. The NTAb titer results would be directly sent to the CRO Data Manager Team, and statistical analysis for immunogenicity would be performed and reported after the main study was complete.

Official title: Long-Term Immunogenicity Study of an Adjuvanted, Inactivated Enterovirus 71 (EV71) Vaccine in Healthy Infants and Children: An Extension Study of Protocol EV-BR1701 Group B1

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