Study Evaluating Treatment of Fever in Children Who Have Been Vaccinated With Prevenar and Infanrix Hexa
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The purpose of the study is to determine whether prophylactic antipyretic treatment after vaccination with Prevenar and a concomitant hexavalent DTPa combination vaccine reduces the rate of febrile reactions.
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
Study Start Date
Primary Completion Date
Study Completion Date
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Ages Eligible for Study:
56 Days to 112 Days (Child)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Healthy infants age 55 to 112 days
Subject's parents/legal guardians provide written informed consent
Prematurely born subjects < 37 weeks gestation
Known or suspected disease of immune system
Known or suspected hypersensitivity to any vaccine or vaccine component