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

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00294294

Purpose

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.

Condition	Intervention	Phase
Vaccines, Pneumococcal Infant Fever, Chemically Induced Drug Therapy, Combination	Biological: Prevenar Biological: Infanrix hexa	Phase IV

MedlinePlus related topics: Fever

Drug Information available for: Heptavalent pneumococcal conjugate vaccine Pneumococcal Vaccines Infanrix hexa

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	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

Further study details as provided by Wyeth:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	300
Study Start Date:	May 2005

Eligibility

Ages Eligible for Study:	56 Days to 112 Days
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00294294

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

Study ID Numbers:	6106A1-500
Study First Received:	February 17, 2006
Last Updated:	May 17, 2006
ClinicalTrials.gov Identifier:	NCT00294294
Health Authority:	European Union: European Medicines Agency

Keywords provided by Wyeth:

vaccine
infant

Study placed in the following topic categories:

Fever

ClinicalTrials.gov processed this record on January 16, 2009