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A Randomized Controlled Open-Label Phase IV Multi Center Study to Assess the Effect of Antipyretic Prophylactic Treatment on the Rate of Febrile Reactions Following Concomitant Contralateral Administr...

Mise à jour : Il y a 4 ans
Référence : EUCTR2004-000397-31

A Randomized Controlled Open-Label Phase IV Multi Center Study to Assess the Effect of Antipyretic Prophylactic Treatment on the Rate of Febrile Reactions Following Concomitant Contralateral Administration of a 7-Valent Pneumococcal Conjugate Vaccine (Prevenar®) and DTPa-HBV-IPV+Hib Vaccine (Infanrix hexa®) in Children at 2, 3, 4 and 11-14 Months of Age

Femme et Homme

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Extrait

To determine the percent reduction in the rate of febrile reactions when prophylactic antipyretic treatment is administered relative to no prophylactic antipyretic treatment after vaccination with a 7-valent pneumococcal conjugate vaccine (7vPnC, Prevenar®) and routine DTPa-HBV-IPV+Hib (Infanrix hexa®) vaccination at 2, 3, 4 (primary series) and 11-14 (booster dose) months of age.

Critère d'inclusion

  • Healthy infants who shall receive their first routine vaccination

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