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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 10.1186/ISRCTN57452882
ClinicalTrials.gov identifier NCT00439660
EudraCT number
Public title 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
Scientific title
Acronym N/A
Serial number at source Protocol No. 1
Study hypothesis 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.
Lay summary
Ethics approval Approved by Independent Ethics Committee and Institutional Review Boards.
Study design Randomised double blind placebo controlled trial
Countries of recruitment India
Disease/condition/study domain Severe rotavirus diarrhoea
Participants - 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
Participants - 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
Anticipated start date 16/08/2006
Anticipated end date 15/02/2008
Status of trial Completed
Patient information material
Target number of participants 540
Interventions Prevention of severe rotavirus diarrhea by vaccination with oral rotavirus candidate vaccine 116E, live attenuated. The control group will receive a placebo vaccine.
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.
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.
Sources of funding Bill and Melinda Gates Foundation (BMGF) through Program for Appropriate Technology in Health (PATH) (USA)
Trial website
Publications 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19545211
Contact name Dr  Nita  Bhandari
  Address B-10
Soami Nagar
  City/town New Delhi
  Zip/Postcode 110 017
  Country India
  Tel +91 (0)11 2601 4136 / 6599
  Fax +91 (0)11 2601 6449
  Email community.research@cih.uib.no
Sponsor Bharat Biotech International Ltd (India)
  Address Genome Valley
Shameerpet (M)
  City/town Hyderabad
  Zip/Postcode 500 078
  Country India
  Tel +91 (0)40 2348 0567
  Fax +91 (0)40 2348 0560
  Email info@bharatbiotech.com
  Sponsor website: http://www.bharatbiotech.com
Date applied 11/07/2006
Last edited 29/09/2009
Date ISRCTN assigned 26/07/2006
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