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Estudio fase 3, randomizado, controlado, doble ciego para evaluar la seguridad, tolerabilidad e inmunogenicidad de la Vacuna Neumocócica Conjugada 13-valente en niños sanos administrada con la vacuna...

Mise à jour : Il y a 4 ans
Référence : EUCTR2007-000304-32

Estudio fase 3, randomizado, controlado, doble ciego para evaluar la seguridad, tolerabilidad e inmunogenicidad de la Vacuna Neumocócica Conjugada 13-valente en niños sanos administrada con la vacuna Meningocóccica C conjugada a toxoide tetánico y otras vacunas de rutina del calendario vacunal en España A Phase 3, Randomized, Active-Controlled, Double-blind Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With a Meningococcal C-Tetanus Toxoid Conjugate Vaccine and Other Routine Pediatric Vaccinations in Spain

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Extrait

Primary objectives: -to demonstrate that the immune response induced by NeisVac-C given with 13vPnC is noninferior to the immune response induced by NeisVac-C given with 7vPnC when measured 1 month after the 2-dose NeisVac-C infant series. -to demonstrate that the immune responses induced by Infanrix hexa given with 13vPnC are noninferior to the immune responses induced by Infanrix hexa given with 7vPnC when measured 1 month after the 3-dose infant series. Safety objective: to evaluate the acceptability of the safety profile of 13vPnC as measured by the incidence rates of local reactions, systemic events, and adverse events (AEs). 13vPnC Immunogenicity objectives: - to assess the immune responses to 13vPnC 1 month after the second dose and 1 month after the third dose of a 3-dose infant series as measured by serum immunoglobulin G (IgG) responses - to assess the immune responses to 13vPnC 1 month after the toddler dose as measured by serum IgG responses.

Critère d'inclusion

  • Healthy infants - Niños sanos

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