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A Phase III Randomized, Double-Blind, Active-Comparator Controlled Clinical Trial to Study the Safety, Tolerability, and Immunogenicity of V419 in Healthy Infants When Given at 2, 3, 4, and 12 Months

Mise à jour : Il y a 5 ans
Référence : EUCTR2010-021490-37

Femme et Homme

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Extrait

1. To evaluate the immunogenicity of PR5I when given at 2, 3, 4, and 12 months. 2. To compare the immunogenicity response elicited by PR5I to that of INFANRIX hexa when given at 2, 3, 4, and 12 months.

Critère d'inclusion

  • PR5I is developed to provide active immunization against diphtheria, tetanus, pertussis, poliomyelitis (caused by poliovirus Types 1, 2 and 3), invasive disease caused by Haemophilus influenza type b and infection caused by all known subtypes of hepatitis B virus,10069577: Pertussis immunisation
  • 10069543: Hemophilus influenzae type b immunization

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