Calendario›SNY›DTwP-HepB-Hib-IPV hexavalent…
DTwP-HepB-Hib-IPV hexavalent…
Study of DTwP-HepB-Hib-IPV (SHAN6™) Vaccine Administered Concomitantly With Routine Pediatric Vaccines to Healthy Infants and Toddlers in Thailand
Ensayo de Sanofi en Pertussis Immunisation · Diphtheria Immunisation · Polio Immunisation · Hepatitis B Immunisation · Haemophilus Influenzae Type B Immunisation · Tetanus Immunisation · Rotavirus Immunisation · Pneumococcal Immunisation (del registro, en inglés).
- Fase
- Fase 3
- Estado
- Completado
- Participantes
- 460
- Centros
- 3
- Fin del objetivo primario
- feb 2021
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, abierto. Comenzó en jun 2020.
Qué mide
Number of participants with antibodies (Ab) above predefined threshold against diphtheria (D), tetanus (T), hepatitis B (Hep B), Haemophilus influenzae type b (Hib) and poliovirus (Polio) antigens (28 days after the third dose (Day 148)) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroPrimary Objective: To demonstrate the non-inferiority of the SHAN6™ vaccine to the licensed SHAN5™ given with bOPV and IPV vaccines when coadministered with PCV and ORV Secondary Objective: * To describe the immunogenicity profile of the SHAN6™ vaccine 3-dose primary infant vaccination and that of the control vaccines (SHAN5™ given with bOPV and IPV) * To describe the immune response to co-administered ORV-1 (Rotarix™) in a subset of participants from each group * To describe the immune response to co-administered PCV-13 (Prevnar 13®) in a subset of participants from each group * To describe the persistence of the antibodies against SHAN6™ antigens following a 3-dose primary series of SHAN6™ or SHAN5™ given with bOPV and IPV * To describe the immunogenicity profile of SHAN6™ 28 days after the single booster dose of SHAN6™ * To describe the safety profile of the SHAN6™ vaccine and the control vaccines (SHAN5™ given with bOPV and IPV), when administered concomitantly with routine pediatric vaccines
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Ficha completa en ClinicalTrials.gov (NCT04429295), actualizada en sep 2025.