Woman and Man
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Extract
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.
Inclusion criteria
- Healthy infants - Niños sanos