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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

February 17, 2006
February 20, 2013
May 2005
December 2006   (final data collection date for primary outcome measure)
Rectal temperature >= 38°C within days 1-4 post vaccination after any of the doses 1-4
Same as current
Complete list of historical versions of study NCT00294294 on ClinicalTrials.gov Archive Site
Rectal temperature > 39.0°C occurring within 4 days of vaccine administration after each of the doses 1-4
Same as current
Not Provided
Not Provided
 
Study Evaluating Treatment of Fever in Children Who Have Been Vaccinated With Prevenar and Infanrix Hexa
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

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Vaccines, Pneumococcal
  • Infant
  • Fever, Chemically Induced
  • Drug Therapy, Combination
  • Biological: Prevenar
  • Biological: Infanrix hexa
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
300
December 2006
December 2006   (final data collection date for primary outcome measure)

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
Both
56 Days to 112 Days
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00294294
6106A1-500
Not Provided
Not Provided
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP