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DTaP-IPV
Immunogenicity Study of Antibody Persistence and Booster Effect of PENTAXIM™ at 18 Months in Healthy Argentinean Infants
Ensayo de Sanofi en Diphtheria · Tetanus · Pertussis · Poliomyelitis · Hepatitis B (del registro, en inglés).
Más ensayos de: Poliomielitis · Hepatitis B.
- Fase
- Fase 3
- Estado
- Completado
- Participantes
- 458
- Centros
- 1
- Fin del objetivo primario
- abr 2007
Qué significa cada fase y cada estado.
Estudio de intervención, no aleatorizado, abierto. Comenzó en feb 2006.
Qué mide
Summary of Antibody Persistence at 18 Months of Age in Participants That Received Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age. (Day 0 (Before booster vaccination)) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroThis study will assess both the antibody persistence of the investigational vaccine and the immune response and safety of a booster dose of PENTAXIM™ vaccine in 18 months-old toddlers who participated in an earlier study in order to determine if they are still protected before they receive a booster dose of D, T, IPV, pertussis or Hib vaccines and also to assess the quality of the induced immune memory in response to a booster dose of the same vaccine as in the primary series. Primary Objective: To describe the antibody persistence at 18 months of age and the booster effect of a dose of PENTAXIM™ on immunogenicity. Secondary objective: To describe the safety profile of the booster dose PENTAXIM™ in each vaccine group defined by the vaccines received during the primary series.
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Todos los de SNY, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT00303316), actualizada en ene 2013.