Prophylactic Antipyretic Treatment in Children Receiving Pneumococcal Conjugate and Standard Infant Vaccines
Phase 3
Completed
- Conditions
- Infections, Rotavirus
- Registration Number
- NCT00370318
- Lead Sponsor
- GlaxoSmithKline
- Brief 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.
- Detailed Description
2 groups (200 per group); control group receives no prophylactic antipyretic treatment.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 400
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Occurrence of fever > or = to 38°C (rectal temperature)
- Secondary Outcome Measures
Name Time Method Safety, reactogenicity and immunogenicity pre and post-vaccination
Trial Locations
- Locations (1)
GSK Investigational Site
🇨🇿Znojmo, Czech Republic