Status:
COMPLETED
Safety and Immunogenicity Study of Live Attenuated Indian Rotavirus Vaccine Candidate Strains 116E and I321 in Infants
Lead Sponsor:
Society for Applied Studies
Collaborating Sponsors:
All India Institute of Medical Sciences
National Institutes of Health (NIH)
Conditions:
Rotavirus Infections
Eligibility:
All Genders
8-12 years
Phase:
PHASE1
Brief Summary
It has been observed that in children who get a severe rotavirus infection, subsequent infections cause either no symptoms or generally only mild or moderate diarrhea. This evidence is the basis for d...
Detailed Description
This study was a phase I randomized, double blind, safety and immunogenicity study of live, attenuated neonatal rotavirus vaccine candidate strains 116E or I321 in healthy non-malnourished infants age...
Eligibility Criteria
Inclusion
- Healthy infants
- Consent available
Exclusion
- Evidence of renal, cardiovascular, liver or other reticuloendothelial, neurological, gastrointestinal, hematologic, rheumatologic or immunologic disease
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2005
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT00280111
Start Date
January 1 2005
End Date
May 1 2005
Last Update
July 2 2008
Active Locations (1)
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1
Society for Applied Studies
New Delhi, National Capital Territory of Delhi, India, 110016