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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 Healthy Infants Given With Routine...

Mise à jour : Il y a 4 ans
Référence : EUCTR2005-005130-12

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 Routine Pediatric Vaccinations in the United Kingdom

Femme et Homme

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Extrait

- To demonstrate that the immune response induced by NeisVac-C or Pediacel given with 13vPnC is noninferior to the immune response induced by NeisVac-C or Pediacel given with 7vPnC when measured 1 month after the infant series. The immune response to the meningococcal C antigen will be assessed using a serum bactericidal assay (SBA). The immune responses to the following antigens in Pediacel will be assessed: acellular pertussis antigens (pertussis toxoid [PT], filamentous haemagglutinin [FHA], pertactin [PRN] and fimbrial agglutinogens ) and Haemophilus influenzae type b (Hib). 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 a 2-dose infant series and before and 1 month after the toddler dose as measured by serum immunoglobulin G (IgG) responses.

Critère d'inclusion

  • Healthy infants

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