Prophylactic Antipyretic Treatment in Children Receiving Pneumococcal Conjugate and Standard Infant Vaccines

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

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.

2 groups (200 per group); control group receives no prophylactic antipyretic treatment.

Inclusion Criteria:

• Healthy children 9-16 weeks old and born after a gestation of at least 36 weeks.

Exclusion Criteria:

• 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.