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Hexavalent vaccine

Concomitant Administration of a New Hexavalent Vaccine With a Meningococcal Serogroup C Conjugate Vaccine in Healthy Infants During Primary Series Immunisation Followed by Booster Vaccination

Ensayo de Sanofi en Neisseria Meningitidis · Bacterial Infections · Virus Diseases (del registro, en inglés).

Fase

Fase 3

Estado

Completado

Participantes

350

previstos

Centros

11

Fin del objetivo primario

jul 2014

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, abierto. Comenzó en abr 2013.

Qué mide

Proportion of subjects with an anti-hepatitis B concentration ≥10 IU/mL (Month 5 (One month after dose 3 of the hexavalent vaccine and dose 2 of MenC vaccine)) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroPrimary Series Primary objectives * To demonstrate that the concomitant administration of the hexavalent vaccine with a meningococcal serogroup C conjugate vaccine is non inferior to the administration of the hexavalent vaccine without a MenC vaccine concomitantly in term of seroprotection rate for hepatitis B one month after the third dose of the hexavalent vaccine * To demonstrate that the concomitant administration of a MenC vaccine with the hexavalent vaccine induces an acceptable response for MenC in term of seroprotection rate (SPR) one month after the second dose of MenC Booster Primary objectives \- To describe the immunogenicity of a booster dose of the hexavalent vaccine and of a meningococcal group ACWY conjugate (MenACWY) vaccine either co-administered at 12 months of age or given separately.

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Ficha completa en ClinicalTrials.gov (NCT01839175), actualizada en sep 2017.