Status:
COMPLETED
Study of 2 Doses of HRV Vaccine Given Concomitantly or Separately With Routine Vaccinations in Healthy Infants in USA
Lead Sponsor:
GlaxoSmithKline
Conditions:
Infections, Rotavirus
Eligibility:
All Genders
6-16 years
Phase:
PHASE3
Brief Summary
The aim of this this study is to confirm absence of immune interference between HRV vaccine and routine infant vaccinations currently in use in the USA.
Detailed Description
A phase III randomized multi-center study to assess the immunogenicity of three doses of Pediarix®, Prevnar® and ActHIB® given to healthy infants at 2, 4 and 6 months of age when administered with Gla...
Eligibility Criteria
Inclusion
- Healthy infants 6 -12 weeks old at Dose 1 with written informed consent.
Exclusion
- Allergic reaction to vaccine components;
- clinically significant history of chronic GI disease (uncorrected GI congenital malformation) or other serious medical condition per investigator, received vaccines or treatment prohibited by the protocol;
- immunocompromised.
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2007
Estimated Enrollment :
484 Patients enrolled
Trial Details
Trial ID
NCT00334607
Start Date
June 1 2006
End Date
June 1 2007
Last Update
November 4 2016
Active Locations (42)
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1
GSK Investigational Site
Benton, Arkansas, United States, 72015
2
GSK Investigational Site
Cabot, Arkansas, United States, 72023
3
GSK Investigational Site
Jonesboro, Arkansas, United States, 72401
4
GSK Investigational Site
Little Rock, Arkansas, United States, 72205