Status:
COMPLETED
Study of 2 Doses of HRV Vaccine Given Concomitantly With Routine EPI Vaccinations Including OPV in Healthy Infants
Lead Sponsor:
GlaxoSmithKline
Conditions:
Infections, Rotavirus
Eligibility:
All Genders
6-12 years
Phase:
PHASE3
Brief Summary
The main objectives of this study is to determine vaccine efficacy against severe rotavirus (RV) gastroenteritis (GE) during the period starting from 2 weeks after Dose 2 until one year of age.
Detailed Description
The study has two groups: Group HRV and Group Placebo. Two oral doses administered to healthy infants who are 6-12 weeks of age at the time of Dose 1, according to a 0, 1 to 2-month schedule. Routine ...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Healthy infants 6 -12 weeks old at Dose 1 with written informed consent.
- Exclusion criteria:
- 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.
Exclusion
Key Trial Info
Start Date :
December 1 2003
Trial Type :
INTERVENTIONAL
End Date :
March 1 2007
Estimated Enrollment :
6360 Patients enrolled
Trial Details
Trial ID
NCT00139347
Start Date
December 1 2003
End Date
March 1 2007
Last Update
October 28 2016
Active Locations (17)
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1
GSK Investigational Site
Colonia Caroya, Córdoba Province, Argentina, X5223CDT
2
GSK Investigational Site
Córdoba, Córdoba Province, Argentina, 5016
3
GSK Investigational Site
Río Cuarto, Córdoba Province, Argentina, 5800
4
GSK Investigational Site
Mendoza, Mendoza Province, Argentina, 5500