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

• Status: Completed
• Trial end date: 2007-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Acetaminophen; Antipyretics; Heptavalent Pneumococcal Conjugate Vaccine; Vaccines

Criteria

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.