Calendario›SNY›Hexaxim®
Hexaxim®
Immunogenicity and Safety of Sanofi Pasteur's Combined Vaccine Given as a Three-Dose Primary Series at 2, 3,4 Months of Age and Followed by a Booster Dose Given at 16 to 17 Months of Age in Vietnamese Infants Who Previously Received a Dose of Hepatitis B Vaccine at Birth or Within 1 Week After Birth
Ensayo de Sanofi en Diphtheria · Tetanus · Pertussis · Poliomyelitis · Hepatitis B · Haemophilus Influenzae Type b (del registro, en inglés).
Más ensayos de: Poliomielitis · Hepatitis B.
- Fase
- Fase 3
- Estado
- Completado
- Participantes
- 354
- Centros
- 1
- Fin del objetivo primario
- ene 2017
Qué significa cada fase y cada estado.
Estudio de intervención, de un solo grupo, abierto. Comenzó en abr 2015.
Qué mide
Number of Participants Reporting Solicited Injection Site Reactions or Solicited Systemic Reactions (Within 7 days after vaccination) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroThe purpose of this study is to describe the immunogenicity and safety of Sanofi Pasteur's DTaP-IPV-Hep B-PRP-T fully liquid combined hexavalent vaccine (Hexaxim®) administered at 2, 3, and 4 months of age and at 16 to 17 months of age in infants and toddlers who received a dose of Hep B vaccine at birth or within 1 week after birth. Primary Objective: * To describe the safety profile after each and all doses of Sanofi-Pasteur's DTaP-IPV-Hep B-PRP-T combined vaccine in Vietnamese infants and toddlers. Secondary Objective: * To demonstrate the non-inferiority of the immune response to all antigens induced by the study vaccine in Vietnamese infants one month after the third dose in a 3-dose primary series with the immune response to all antigens induced by the same study vaccine outside Vietnam. * To evaluate the immunogenicity of the study vaccine one month after the 3-dose primary series. * To describe the persistence of all antibodies before receipt of the booster vaccination. * To evaluate the immunogenicity of the study vaccine one month after the booster.
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Todos los de SNY, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT02428491), actualizada en mar 2022.