Prophylactic Antipyretic Treatment in Children Receiving Pneumococcal Conjugate and Standard Infant Vaccines
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The purpose of this trial is to assess if the rate of febrile reactions following the co-administration of pneumococcal conjugate vaccines with standard infant vaccines is lowered when paracetamol is given prophylactically.
Multicentre Study to Assess the Effect of Prophylactic Antipyretic Treatment on the Rate of Febrile Reactions Following Concomitant Administration of GSK Biologicals' 10-valent Pneumococcal Conjugate, Infanrix Hexa and Rotarix Vaccines
Study Start Date :
Actual Study Completion Date :
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Ages Eligible for Study:
9 Weeks to 16 Weeks (Child)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Healthy children 9-16 weeks old and born after a gestation of at least 36 weeks.
Body weight < 4.5 kg
Children having received or planning to receive any investigational or non-registered products, vaccines not foreseen in the protocol, and immune modifying drugs
Children with any disease that affects the immune system or gastro-intestinal tract
Children with a history of seizures, allergic disease, or disease(s) covered by the vaccines
Children with contraindication to paracetamol treatment.