A double-blind randomised placebo controlled dose escalating phase Ib/IIa study to evaluate the safety and immunogenicity of live attenuated rotavirus vaccine 116E in healthy non-malnourished infants eight to 20 weeks of age
- Conditions
- Severe rotavirus diarrhoeaInfections and InfestationsViral and other specified intestinal infections
- Registration Number
- ISRCTN57452882
- Lead Sponsor
- Bharat Biotech International Ltd (India)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 540
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
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
9. Evidence of liver or reticuloendothelial disease
10. Evidence of hematologic, rheumatologic or immunologic disease
11. Evidence of renal disease
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluation of the safety of vero cell based 116E rotavirus vaccine candidate strain 116E administered three times orally at four week intervals.
- Secondary Outcome Measures
Name Time Method Evaluation of the immunogenicity of vero cell based 116E rotavirus vaccine candidate strain 116E administered three times orally at four week intervals.