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

GlaxoSmithKline1 site in 1 country400 target enrollmentSeptember 2006

ConditionsInfections, Rotavirus

DrugsParacetamol

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Infections, Rotavirus
Sponsor: GlaxoSmithKline
Enrollment: 400
Locations: 1
Primary Endpoint: Occurrence of fever > or = to 38°C (rectal temperature)
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 2006

End Date

April 2007

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

GlaxoSmithKline

Responsible Party

Sponsor

Eligibility 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.