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

Last updated on May 12, 2018

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Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pneumococcal Vaccines, Infant, Chemically Induced Fever, Combination Drug Therapy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
56-112 days
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Healthy infants age 55 to 112 days

- Subject's parents/legal guardians provide written informed consent

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Prematurely born subjects

- Known or suspected disease of immune system

- Known or suspected hypersensitivity to any vaccine or vaccine component

NCT00294294
Pfizer
Completed
Study Evaluating Treatment of Fever in Children Who Have Been Vaccinated With Prevenar and Infanrix Hexa

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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
Intervention Model: Parallel Assignment
Masking: None (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
Sexes Eligible for Study: All
56 Days to 112 Days   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00294294
6106A1-500
Not Provided
Not Provided
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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

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Contact

[email protected]



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