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A Phase 3, Randomized, Active-controlled, Double-Blind Trial of the Safety, Tolerability and Immunologic Noninferiority of a 13-valent Pneumococcal Conjugate Vaccine Compared to a 7-valent Pneumococca...

Mise à jour : Il y a 4 ans
Référence : EUCTR2005-004770-24

A Phase 3, Randomized, Active-controlled, Double-Blind Trial of the Safety, Tolerability and Immunologic Noninferiority of a 13-valent Pneumococcal Conjugate Vaccine Compared to a 7-valent Pneumococcal Conjugate Vaccine in Healthy Infants Given in a 2-, 3-, 4- and 11- to 12-Months Schedule With Routine Pediatric Vaccinations

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Extrait

- To demonstrate that the immune responses to the 7 common pneumococcal conjugates induced by 13vPnC are noninferior to the immune responses induced by 7vPnC when measured 1 month after the infant series. - To demonstrate that the immune responses to the 6 additional pneumococcal conjugates induced by 13vPnC are noninferior to the lowest immune response, among the 7 common pneumococcal conjugates, induced by 7vPnC when measured 1 month after the 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 infant series. Safety objective: - To evaluate the acceptability of the safety profile of 13vPnC as measured by the incidence rates of local injection site reactions, systemic events, and adverse events (AEs).

Critère d'inclusion

  • Healthy infants

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