Epidemiology of rotavirus in North India Community
Not Applicable
Completed
- Registration Number
- CTRI/2012/01/002353
- Lead Sponsor
- Society for Applied Studies
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
Inclusion Criteria
Parents/guardian consent for participation and are able to understand study procedures
- Healthy infant aged less than or equal to 1 week â?? 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 Criteria
- 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 â??illâ??, investigators suspects neglect).
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Disease Burden: All episodes of gastroenteritis (GE): rotavirus GE, rotavirus GE by G and P types, severe GE, severe rotavirus GE, severity score of all GE episodes <br/ ><br>Rates of hospitalization; <br/ ><br>Proportion requiring rehydration therapy <br/ ><br>Duration of rotavirus shedding duration after rotavirus GE episode <br/ ><br>Rotavirus genotypes <br/ ><br>Data collection for planning and implementation of phase III trials: trial logistics, data collection tools, validity of questions including those in the Vesikari scoreTimepoint: 1 year
- Secondary Outcome Measures
Name Time Method -Timepoint: -