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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00294294
Recruitment Status : Completed
First Posted : February 20, 2006
Last Update Posted : February 21, 2013
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

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.

Condition or disease Intervention/treatment Phase
Vaccines, Pneumococcal Infant Fever, Chemically Induced Drug Therapy, Combination Biological: Prevenar Biological: Infanrix hexa Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : May 2005
Primary Completion Date : December 2006
Study Completion Date : December 2006





Primary Outcome Measures :
  1. Rectal temperature >= 38°C within days 1-4 post vaccination after any of the doses 1-4

Secondary Outcome Measures :
  1. Rectal temperature > 39.0°C occurring within 4 days of vaccine administration after each of the doses 1-4


Information from the National Library of Medicine

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Ages Eligible for Study:   56 Days to 112 Days   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00294294     History of Changes
Other Study ID Numbers: 6106A1-500
First Posted: February 20, 2006    Key Record Dates
Last Update Posted: February 21, 2013
Last Verified: February 2013

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
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs