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
| ISRCTN | ISRCTN57452882 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN57452882 |
| ClinicalTrials.gov (NCT) | NCT00439660 |
| Protocol serial number | Protocol No. 1 |
| Sponsor | Bharat Biotech International Ltd (India) |
| Funder | Bill and Melinda Gates Foundation (BMGF) through Program for Appropriate Technology in Health (PATH) (USA) |
- Submission date
- 11/07/2006
- Registration date
- 26/07/2006
- Last edited
- 29/09/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Nita Bhandari
Scientific
Scientific
B-10
Soami Nagar
New Delhi
110 017
India
| Phone | +91 (0)11 2601 4136 / 6599 |
|---|---|
| community.research@cih.uib.no |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised double blind placebo controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Prevention of severe rotavirus diarrhoea in infants by vaccination with the oral rotavirus candidate vaccine 116E, naturally attenuated and reassorted in nature, isolated from an asymptomatic infant. |
| Ethics approval(s) | Approved by Independent Ethics Committee and Institutional Review Boards. |
| Health condition(s) or problem(s) studied | Severe rotavirus diarrhoea |
| Intervention | Prevention of severe rotavirus diarrhea by vaccination with oral rotavirus candidate vaccine 116E, live attenuated. The control group will receive a placebo vaccine. |
| Intervention type | Drug |
| Phase | Phase I/II |
| Drug / device / biological / vaccine name(s) | Rotavirus candidate vaccine 116E |
| Primary outcome measure(s) |
Evaluation of the safety of vero cell based 116E rotavirus vaccine candidate strain 116E administered three times orally at four week intervals. |
| Key secondary outcome measure(s) |
Evaluation of the immunogenicity of vero cell based 116E rotavirus vaccine candidate strain 116E administered three times orally at four week intervals. |
| Completion date | 15/02/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 6 Weeks |
| Upper age limit | 6 Weeks |
| Sex | All |
| Target sample size at registration | 540 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 16/08/2006 |
| Date of final enrolment | 15/02/2008 |
Locations
Countries of recruitment
- India
Study participating centre
B-10
New Delhi
110 017
India
110 017
India
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/08/2009 | Yes | No |
