Study Evaluating Treatment of Fever in Children Who Have Been Vaccinated With Prevenar and Infanrix Hexa
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT00294294
Collaborator
(none)
300
19
Study Details
Study Description
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 |
|---|---|---|
|
Phase 4 |
Study Design
Study Type:
Interventional
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 1, 2005
Actual Primary Completion Date
:
Dec 1, 2006
Actual Study Completion Date
:
Dec 1, 2006
Outcome Measures
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 []
Eligibility Criteria
Criteria
Ages Eligible for Study:
56 Days
to 112 Days
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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
Locations
No locations specified.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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00294294
Other Study ID Numbers:
- 6106A1-500
First Posted:
Feb 20, 2006
Last Update Posted:
Feb 21, 2013
Last Verified:
Feb 1, 2013
Keywords provided by ,
,
Additional relevant MeSH terms: