This is phase one study with healthy adult participants to be enrolled to receive study product to check the safety and tolerability of liquid rotavirus vaccine in healthy adults
- Registration Number
- CTRI/2015/11/006384
- Lead Sponsor
- Serum Institute of India Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
1. Healthy adult male or non-pregnant female subjects aged between 18-45 years and normal Body Mass Index (18.5 to 24.9 kg/m2) with minimum of
50 kg weight.
2. Normal health as determined by medical history, clinical examination and
laboratory assessment.
3. Subjects willing to adhere to the protocol requirements and to provide
written informed consent
4. Availability for clinical follow up through period of the study.
1. Investigator site personnel directly affiliated with this study and their immediate families.
2. Fever or any acute infection at time of immunization.
3. History of diarrhea or blood in stool or abnormal stool pattern in past one week.
4. A known hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the study vaccine or a vaccine containing the same substances.
5. History or presence of asthma, urticaria or other allergic reaction.
6. History of chronic gastrointestinal disease, intussusceptions, gastrointestinal malformation or abdominal surgery.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method