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

Phase 4 Completed 300 enrolled Wyeth is now a wholly owned subsidiary of Pfizer

RandomizedParallel-groupOpen-labelPrevention

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.

Timeline

Start: 2005-05
Primary completion: 2006-12
Completion: 2006-12

Publications

Rose MA, Juergens C, Schmoele-Thoma B, Gruber WC, Baker S, Zielen S. An open-label randomized clinical trial of prophylactic paracetamol coadministered with 7-valent pneumococcal conjugate vaccine and hexavalent diphtheria toxoid, tetanus toxoid, 3-component acellular pertussis, hepatitis B, inactivated poliovirus, and Haemophilus influenzae type b vaccine. BMC Pediatr. 2013 Jun 21;13:98. doi: 10.1186/1471-2431-13-98.

Drugs

Evaluation	Drug	Modality	Dose	Route
Background	Infanrix hexa	Vaccine	—	—
Background	Prevnar 13	Vaccine	—	—

Indications

No indication recorded.