NCT00294294

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

A Randomized Controlled Open-Label Phase IV Multi Center Study to Assess the Effect of Antipyretic Prophylactic Treatment on the Rate of Febrile Reactions Following Concomitant Contralateral Administration of a 7-Valent Pneumococcal Conjugate Vaccine (Prevenar®) and DTPa-HBV-IPV+Hib Vaccine (Infanrix Hexa®) in Children at 2, 3, 4 and 11-14 Months of Age

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 300 (planned)
• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer · Industry
• Sex: All
• Age: 56 Days – 112 Days
• Healthy volunteers: Accepted

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.

Conditions

• Vaccines, Pneumococcal
• Infant
• Fever, Chemically Induced
• Drug Therapy, Combination

Interventions

Type	Name	Description
BIOLOGICAL	Prevenar
BIOLOGICAL	Infanrix hexa

Timeline

• Start date: 2005-05-01
• Primary completion: 2006-12-01
• Completion: 2006-12-01
• First posted: 2006-02-20
• Last updated: 2013-02-21