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Euvax B®: Hepatitis B vaccine

Anti-Hep B Antibodies at Age 9 to 10 Years After Hep B Vaccine at Birth and DTaP-IPV-Hep B-PRP-T Hexavalent Vaccine.

Ensayo de Sanofi en Hepatitis B.

Más ensayos de: Hepatitis B.

Fase

Fase 3

Estado

Completado

Participantes

150

previstos

Centros

2

Fin del objetivo primario

jun 2016

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, no aleatorizado, abierto. Comenzó en feb 2016.

Qué mide

Levels of anti-Hepatitis B antibody concentrations in subject that received Hexaxim® or Infanrix® hexa vaccine in a previous study (Day 0 (pre-vaccination)) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe aim of the study is to assess the persistence of anti-Hep B antibody at 9 to 10 years of age after the last priming dose in subjects who completed study A3L12 (NCT00401531), and also evaluate the immune response against hepatitis B one month after vaccination (challenge vaccination) with a stand alone monovalent hepatitis B vaccine. Primary objectives: * To describe the persistence of anti-hepatitis B antibody at 9 to 10 years of age after last priming dose in subjects having received hepatitis B vaccine at birth and a hexavalent vaccine at 2, 4 and 6 months of age according to the vaccine received during A3L12 study (Hexaxim® \[Group 1\] or Infanrix® hexa \[Group 2\]) * To evaluate the immune response against hepatitis B one month after vaccination with a stand alone monovalent hepatitis B vaccine (challenge vaccination). Secondary objectives: * To describe serious adverse events (SAEs) reported throughout the trial after administration of hepatitis B vaccine.

Más ensayos de SNY

Todos los de SNY, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT02697474), actualizada en mar 2022.