Clinical Trials/NCT00294294

NCT00294294

Completed

Phase 4

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

Wyeth is now a wholly owned subsidiary of Pfizer0 sites300 target enrollmentMay 2005

ConditionsVaccines, Pneumococcal Infant Fever, Chemically Induced Drug Therapy, Combination

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Vaccines, Pneumococcal
Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Enrollment: 300
Primary Endpoint: Rectal temperature >= 38°C within days 1-4 post vaccination after any of the doses 1-4
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 2005

End Date

December 2006

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

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