Calendario›SNY›DTaP-IPV combined vaccine
DTaP-IPV combined vaccine
Immunogenicity and Safety of Tetraxim Versus Local DTP + IPV
Ensayo de Sanofi en Pertussis · Diphtheria · Poliomyelitis · Tetanus (del registro, en inglés).
Más ensayos de: Poliomielitis.
- Fase
- Fase 3
- Estado
- Completado
- Participantes
- 442
- Centros
- 1
- Fin del objetivo primario
- abr 2008
previstos
fecha real
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, abierto. Comenzó en abr 2006.
Qué mide
To provide information concerning the immunogenicity of Sanofi Pasteur's DTaP-IPV combined vaccine versus commercially available Biken's DTaP and Aventis Pasteur's IPV (IMOVAX POLIO) monovalent vaccines. (1 month post-vaccination) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroThe present clinical study will assess the immunogenicity and reactogenicity of Sanofi Pasteur's DTaP-IPV combined vaccines as a three-dose primary vaccination at 2, 4 and 6 months of age compared to commercially available vaccines in order to meet the requirements for registration of the product in South Korea. Primary objective To demonstrate the non-inferiority in terms of seroprotection rates (Diphtheria, Tetanus, Polio types 1, 2 and 3) and seroconversion/vaccine response rates to Pertussis antigens (PT, FHA) of Sanofi Pasteur's DTaP-IPV combined vaccine versus commercially available Biken's DTaP (CJ purified PDT vaccine ™) and Aventis Pasteur's IPV (IMOVAX POLIO) monovalent vaccines, one month after the three-dose primary vaccination. Secondary objectives 1. Immunogenicity: To assess the non-inferiority in terms of seroprotection rates (Diphtheria, Tetanus, Polio types 1, 2 and 3) and seroconversion / vaccine response rates to Pertussis antigens (PT, FHA) of Sanofi Pasteur's DTaP-IPV combined vaccine versus historical reference (Study E2I03294 - France). To assess and describe the immunogenicity of the study vaccines in both groups. 2. Safety: To assess and describe the safety of the study vaccines after each dose.
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Todos los de SNY, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT00319852), actualizada en abr 2012.