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.

Study Timeline

• Study First Submitted: 2006-06-02
• Study First Submitted QC: 2006-08-30
• Study First Posted: 2006-08-31
• Study Start: 2006-09
• Study Completion: 2007-04
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-21
• Last Update Posted: 2017-03-23

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