Extension Study of Protocol EV-BR1701 Group B1
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
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.
Panoramica dello studio
Stato
Condizioni
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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Vinh Long Province
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Vĩnh Long, Vinh Long Province, Vietnam
- Centers for Disease Control and Prevention, Vinh Long Province, Vietnam
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
Accetta volontari sani
Metodo di campionamento
Popolazione di studio
The main study is a randomized, multi-nation, multi-centered, double-blinded, phase III study on subjects aged 2 months to <6 years old (<72 months). Two parts are conducted in Taiwan (Group A) and Vietnam (Group B). This extended study involves 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 will be assigned to this extension study. The extension study aims to evaluate the immunogenicity persistence after EnVAX-A71 vaccination.
The subjects of Group B1 will be recalled for phlebotomy and immunogenicity analysis. The subjects will not receive further study EV71 vaccines in the extension study.
Descrizione
Inclusion Criteria:
- Healthy children enrolled in group B1 of the EV-BR1701 study who received at least one dose of IP injection with the duration after the last vaccination from at least 2 years up to 2 years and 6 months.
- The subject's guardians are able and willing to comply with study procedures and provide signed informed consent.
Exclusion Criteria:
- Severe malnutrition or dysgenopathy at the screening visit.
- Bleeding disorder diagnosed by a doctor or significant bruising or hemostatic difficulties with IM injections or phlebotomy.
- Any condition in the investigator's opinion may interfere with evaluating study objectives.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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This extension study aims to assess the long-term immunogenicity of EnVAX-A71 vaccination in children aged two months to under six years old.
Lasso di tempo: From Dec-2024 to Jan-2025
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To determine the serum EV71-specific neutralizing antibody (NTAb) titers by measuring the GMT, SCRa, and SPRb for those subjects from Part B1 upon recall.
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From Dec-2024 to Jan-2025
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Collaboratori e investigatori
Sponsor
Investigatori
- Direttore dello studio: Wendy Wu, Enimmune Corporation
Studiare le date dei record
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Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- EV-BR1701e
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