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

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00294294
First received: February 17, 2006
Last updated: February 20, 2013
Last verified: February 2013
History of Changes
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:

MedlinePlus related topics: Fever
U.S. FDA Resources

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

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
Study Completion Date: December 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
  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 is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00294294     History of Changes
Other Study ID Numbers: 6106A1-500
Study First Received: February 17, 2006
Last Updated: February 20, 2013
Health Authority: European Union: European Medicines Agency

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
vaccine
infant

Additional relevant MeSH terms:
Fever
Body Temperature Changes
Signs and Symptoms

ClinicalTrials.gov processed this record on June 17, 2013