A phase 3, randomized, Active-Controlled, Double-blind Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Healhy Infants Given With Routine Pediatric Vaccination in Italy

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Extract

Primary objective To demonstrate that the immune response induced by Infanrix hexa given with 13vPnC is noninferior to the immune response induced by Infanrix hexa given with 7vPnC when measured 1 month after the toddler dose. Response to the following antigen in Infanrix hexa will be assessed hepatitis B. 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 . 13vPnC Immunogenicity objectives To assess the immune response to 13vPnC 1 month after the infant series as measured by serum immunoglobulin G IgG responses. To assess the immune response to 13vPnC before and 1 month after the toddler dose as measured by serum IgG responses.

Inclusion criteria

Healthly infants

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A phase 3, randomized, Active-Controlled, Double-blind Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Healhy Infants Given With Routine ...