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DTaP
A Study of DTaP//PRP-T Combined Vaccine (ACTACEL) Versus Local DTaP and Act-HIB Monovalent Vaccine in Healthy Infants
Ensayo de Sanofi en Diphtheria · Tetanus · Pertussis · Haemophilus Influenzae Type B (del registro, en inglés).
- Fase
- Fase 3
- Estado
- Completado
- Participantes
- 1.056
- Centros
- 2
- Fin del objetivo primario
- sep 2011
previstos
fecha real
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, abierto. Comenzó en ene 2010.
Qué mide
Immunogenicity: To provide information concerning the immunogenicity of ACTACEL vaccine after primary and booster vaccination. (One month post-vaccination) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroThe purpose of this study is to assess the immunogenicity and safety of ACTACEL combined vaccine in support of registration of this product in China Primary Objectives: * To demonstrate that ACTACEL vaccine administered at 2, 3 and 4 months of age or at 3, 4 and 5 months of age is not inferior, in terms of seroprotection, to Wuhan's Diphtheria, Tetanus, acellular Pertussis (DTaP) and Haemophilus influenzae type b (Act-HIB) vaccine given concomitantly, for diphtheria, tetanus, and Polyribosyl Ribitol Phosphate (PRP) antigens, one month after the three-dose primary vaccination. * To demonstrate the superiority, in terms of seroconversion, of ACTACEL vaccine administered at 2, 3 and 4 months of age or at 3, 4 and 5 months of age for Pertussis Toxoid (PT), Fimbriae types 2 and 3 (FIM2) and (FIM3) pertussis antigens, compared with Wuhan's DTaP and Act-HIB vaccines given concomitantly, one month after the three-dose primary vaccination. Secondary Objectives: * To describe the safety after administration of the study vaccines. * To describe in each group the immunogenicity of the study vaccines one month after the primary vaccination and before and one month after the booster vaccination.
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Todos los de SNY, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT01062477), actualizada en dic 2011.