Severe rotavirus diarrhoea Infections and Infestations Viral and other specified intestinal infections
Conditions
Interventions
Prevention of severe rotavirus diarrhea by vaccination with oral rotavirus candidate vaccine 116E, live attenuated. The control group will receive a placebo vaccine.
Sponsors
Bharat Biotech International Ltd (India)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Access to a telephone 2. Healthy male and female non-malnourished infants aged six weeks (till six weeks + two days) 3. Parents' permission to participate 4. No plans to travel over the next four months
Exclusion criteria
Exclusion criteria: 1. Gestational age less than 37 weeks 2. Any major physical congenital malformation 3. Contact with immunosuppressed individuals 4. Hospitalised once or more for the following illnesses since birth: heart disease, pneumonia, sepsis, meningitis, unconsciousness 5. Daily medications other than vitamins or herbal "tonics" 6. Evidence of cardiovascular disease 7. Evidence of gastrointestinal disease<br/8. Evidence of neurological disease 9. Evidence of liver or reticuloendothelial disease 10. Evidence of hematologic, rheumatologic or immunologic disease 11. Evidence of renal disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of the safety of vero cell based 116E rotavirus vaccine candidate strain 116E administered three times orally at four week intervals. | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of the immunogenicity of vero cell based 116E rotavirus vaccine candidate strain 116E administered three times orally at four week intervals. | — |
Countries
India
Outcome results
None listed