Calendario›SNY›Hexaxim®: DTaP-IPV-HB-PRP-T…
Hexaxim®: DTaP-IPV-HB-PRP-T…
DTaP-IPV-HB-PRP-T Combined Vaccine as a Primary Series and a Second Year of Life Booster in HIV-Exposed Infected and Uninfected Infants
Ensayo de Sanofi en Diphtheria · Tetanus · Pertussis · Hepatitis B · Polio · Human Immunodeficiency Virus Infection (del registro, en inglés).
Más ensayos de: Hepatitis B.
- Fase
- Fase 3
- Estado
- Completado
- Participantes
- 53
- Centros
- 1
- Fin del objetivo primario
- feb 2019
Qué significa cada fase y cada estado.
Estudio de intervención, no aleatorizado, abierto. Comenzó en jul 2016.
Qué mide
Number of Participants with Anti-Pertussis Toxoid (PT) and Anti-Filamentous Hemagglutinin (FHA) Antibody (Ab) Concentrations >= Lower Limit of Quantification (LLOQ) and >=4*LLOQ at Baseline (Day 0 (baseline)) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroThis study aims to assess and confirm the adequate immunogenicity and safety profile of the Sanofi Pasteur's DTaP-Hep B-IPV-PRP-T fully liquid combined hexavalent vaccine administered in HIV-exposed uninfected infants and in HIV-exposed infected infants. The primary objectives of the study are: * To evaluate the immunogenicity of the study vaccine 1 month after the 3-dose primary series in HIV-exposed infected and in HIV-exposed uninfected infants. * To describe the persistence of all antibodies before receipt of the booster dose in HIV-exposed infected and in HIV-exposed uninfected infants. * To evaluate the immunogenicity of the study vaccine 1 month after the booster dose in HIV-exposed infected and in HIV-exposed uninfected infants. The secondary objectives of the study are: * To describe the safety profile after each and all doses of the study vaccine administered as a 3-dose infant primary series in HIV-exposed infected and in HIV-exposed uninfected infants. * To describe the safety profile of the study vaccine administered as a booster in HIV-exposed infected and in HIV-exposed uninfected infants.
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Todos los de SNY, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT02817451), actualizada en mar 2022.