Status:
COMPLETED
A Study in Infants to Test Two Preparations (Freeze-dried or Liquid) of the Rotavirus Vaccine (HRV Vaccine).
Lead Sponsor:
GlaxoSmithKline
Conditions:
Infections, Rotavirus
Eligibility:
All Genders
11-17 years
Phase:
PHASE3
Brief Summary
The aim of this this study is to evaluate the lot-to-lot consistency of the liquid formulation of GSK Biologicals' HRV vaccine and to evaluate the liquid formulation compared to the lyophilised formul...
Eligibility Criteria
Inclusion
- Healthy infants birth weigh \>2000 g, 11 -17 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 :
November 1 2006
Trial Type :
INTERVENTIONAL
End Date :
August 1 2007
Estimated Enrollment :
1200 Patients enrolled
Trial Details
Trial ID
NCT00382772
Start Date
November 1 2006
End Date
August 1 2007
Last Update
November 4 2016
Active Locations (12)
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1
GSK Investigational Site
Espoo, Finland, 02100
2
GSK Investigational Site
Helsinki, Finland, 00100
3
GSK Investigational Site
Helsinki, Finland, 00930
4
GSK Investigational Site
Jarvenpaa, Finland, 04400