Clinical Research Directory

An Extension Study of EV-BR1701 Part A1

To determine the long-term immunogenicity more than 5 years after EnVAX-A71 vaccination in the pediatric population aged 2 months to \<6 years when first vaccinated.

Extension Study of Protocol EV-BR1701 Group B1

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.

Molecular Epidemiology of Enteroviruses Detected at the Virology Laboratory of Brest University Hospital During the Period 2018-2024: Retrospective Analysis of an Atypical Meningitis Epidemic in 2024 (BrEcho9Men)

This study is being done to learn more about enterovirus infections detected in the cerebrospinal fluid of patients at CHU de Brest. Researchers will analyze medical records and laboratory data collected between 2018 and 2024. They will look at how these infections present in patients, and whether a specific virus type, called Echo-9, may be associated with different clinical features or represent an emerging variant.

A Study to Evaluate the Efficacy, Immunogenicity and Safety of an EV71 Vaccine in Healthy Infants and Children

The objectives of this study are to evaluate the EV71vaccine efficacy, immune response and safety profiles after two injections of the cell culture-based inactivated EV71 vaccine with adjuvant Al(OH)3 administrated in pediatric population aged 2 months to 6 years old.

Surveillance of HFMD in Pediatric Outpatients

The aims of this prospective multicentric study is to determine the types of enteroviruses (EVs) responsible for hand, foot and mouth disease (HFMD) or herpangina in children seen within an ambulatory setting : * to detect an EV-A71 epidemic or another type associated with atypical forms of the disease at an early stage * to describe and compare the epidemiological, demographic, clinical and virological characteristics of these infections between the different types of EV.