Condition category
Infections and Infestations
Date applied
11/07/2006
Date assigned
26/07/2006
Last edited
29/09/2009
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Nita Bhandari

ORCID ID

Contact details

B-10
Soami Nagar
New Delhi
110 017
India
+91 (0)11 2601 4136 / 6599
community.research@cih.uib.no

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00439660

Protocol/serial number

Protocol No. 1

Study information

Scientific title

Acronym

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.

Ethics approval

Approved by Independent Ethics Committee and Institutional Review Boards.

Study design

Randomised double blind placebo controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Prevention

Patient information sheet

Condition

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 names

Rotavirus candidate vaccine 116E

Primary outcome measures

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

Evaluation of the immunogenicity of vero cell based 116E rotavirus vaccine candidate strain 116E administered three times orally at four week intervals.

Overall trial start date

16/08/2006

Overall trial end date

15/02/2008

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

540

Participant 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

Recruitment start date

16/08/2006

Recruitment end date

15/02/2008

Locations

Countries of recruitment

India

Trial participating centre

B-10
New Delhi
110 017
India

Sponsor information

Organisation

Bharat Biotech International Ltd (India)

Sponsor details

Genome Valley
Shameerpet (M)
Hyderabad
500 078
India
+91 (0)40 2348 0567
info@bharatbiotech.com

Sponsor type

Industry

Website

http://www.bharatbiotech.com

Funders

Funder type

Charity

Funder name

Bill and Melinda Gates Foundation (BMGF) through Program for Appropriate Technology in Health (PATH) (USA)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19545211

Publication citations

  1. Results

    Bhandari N, Sharma P, Taneja S, Kumar T, Rongsen-Chandola T, Appaiahgari MB, Mishra A, Singh S, Vrati S, , A dose-escalation safety and immunogenicity study of live attenuated oral rotavirus vaccine 116E in infants: a randomized, double-blind, placebo-controlled trial., J. Infect. Dis., 2009, 200, 3, 421-429, doi: 10.1086/600104.

Additional files

Editorial Notes