Study Evaluating Treatment of Fever in Children Who Have Been Vaccinated With Prevenar and Infanrix Hexa

Phase 4

Completed

• Conditions: Vaccines, Pneumococcal; Infant; Fever, Chemically Induced; Drug Therapy, Combination

• Registration Number: NCT00294294
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

The purpose of the study is to determine whether prophylactic antipyretic treatment after vaccination with Prevenar and a concomitant hexavalent DTPa combination vaccine reduces the rate of febrile reactions.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-05
• Study First Submitted: 2006-02-17
• Study First Submitted QC: 2006-02-17
• Study First Posted: 2006-02-20
• Primary Completion: 2006-12
• Study Completion: 2006-12
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-20
• Last Update Posted: 2013-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Healthy infants age 55 to 112 days
• Subject's parents/legal guardians provide written informed consent

Exclusion Criteria

• Prematurely born subjects < 37 weeks gestation
• Known or suspected disease of immune system
• Known or suspected hypersensitivity to any vaccine or vaccine component

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Rectal temperature >= 38°C within days 1-4 post vaccination after any of the doses 1-4

Secondary Outcome Measures

Name	Time	Method
Rectal temperature > 39.0°C occurring within 4 days of vaccine administration after each of the doses 1-4