Status:
COMPLETED
Epidemiology of Rotavirus Infection in North India Community
Lead Sponsor:
Society for Applied Studies
Collaborating Sponsors:
National Institute of Immunology, New Delhi
Ministry of Science and Technology, India
Conditions:
Rotavirus Gastroenteritis
Eligibility:
All Genders
1-24 years
Brief Summary
This study was designed to support site preparation and to conduct a disease burden study for the planning and implementation of the phase III trials for the oral rotavirus vaccine 116E.
Detailed Description
Field workers conducted weekly surveillance in areas allocated to them and identified pregnant women, newborns and infants aged 9 to 12 months. Children who were eligible for participation through cri...
Eligibility Criteria
Inclusion
- Parents/guardian consent for participation and are able to understand study procedures
- Healthy infant aged ≤ 1 week - cohort I, children aged 12 months (+14 days)-Cohort 2
- Absence of any illness requiring hospitalization
- No confirmed plans to move in the next 12 months
Exclusion
- Participating in any other trial
- Any signs or symptoms of active sepsis, pneumonia, meningitis or any other disease requiring hospitalization
- Known case of immunodeficiency disease, known HIV positive
- Known case of chronic gastrointestinal disease
- Any other conditions which in the judgment of the investigator warrant exclusion(e.g. no exclusion criteria but seems 'ill', investigators suspects neglect)
Key Trial Info
Start Date :
July 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT01508533
Start Date
July 1 2009
End Date
September 1 2010
Last Update
January 12 2012
Active Locations (1)
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1
Society for Applied Studies
New Delhi, National Capital Territory of Delhi, India, 110016