Calendario›SNY›Hexaxim™: DTaP-IPV-Hep B-PRP~T…
Hexaxim™: DTaP-IPV-Hep B-PRP~T…
Study of DTaP-IPV-Hep B-PRP~T Combined Vaccine in Indian Infants Previously Given a Dose of Hepatitis B Vaccine at Birth
Ensayo de Sanofi en Diphtheria · Tetanus · Whooping Cough · Hepatitis B · Poliomyelitis · Invasive Hib Infections (del registro, en inglés).
Más ensayos de: Hepatitis B · Poliomielitis.
- Fase
- Fase 3
- Estado
- Completado
- Participantes
- 177
- Centros
- 2
- Fin del objetivo primario
- dic 2014
Qué significa cada fase y cada estado.
Estudio de intervención, de un solo grupo, abierto. Comenzó en feb 2014.
Qué mide
Percentage of Participants With Seroprotection After Vaccinations With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of a Commercial Oral Poliovirus Vaccine and Recombinant Hep B Monovalent Vaccine at Birth (Pre-dose 1 to one month post-dose 3) (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 a novel DTaP- IPV- Hep B-PRT\~T fully liquid combined hexavalent vaccine (Hexaxim™) administered at 6, 10 and 14 weeks of age in infants born to mothers documented to be serum anti-hepatitis B surface antigen (HBsAg) serology negative in India. Primary Objective: * To evaluate the immunogenicity of the study vaccine in terms of seroprotection \[diphtheria toxoid, tetanus toxoid, poliovirus types 1, 2 and 3, Haemophilus influenzae type b (Hib) polysaccharide (PRP), hepatitis B (Hep B)\] and vaccine response for pertussis antigens \[pertussis toxoid (PT) and filamentous haemagglutinin (FHA)\] one month after the third dose. Secondary Objectives: * To further describe the immunogenicity of the study vaccine, before the first dose and one month after the third dose. * To describe the safety after each and any doses of the study vaccine.
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Todos los de SNY, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT01948193), actualizada en sep 2015.