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 number	NCT00439660
Secondary identifying numbers	Protocol No. 1

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Nita Bhandari
Scientific

B-10
Soami Nagar
New Delhi
110 017
India

Phone	+91 (0)11 2601 4136 / 6599
Email	community.research@cih.uib.no

Study design	Randomised double blind placebo controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Prevention
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
Pharmaceutical study type(s)
Phase	Phase I/II
Drug / device / biological / vaccine name(s)	Rotavirus candidate vaccine 116E
Primary outcome measure	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 study start date	16/08/2006
Completion date	15/02/2008

Participant type(s)	Patient
Age group	Child
Lower age limit	6 Weeks
Upper age limit	6 Weeks
Sex	Both
Target number of participants	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

B-10

New Delhi
110 017
India

Bharat Biotech International Ltd (India)
Industry

Genome Valley
Shameerpet (M)
Hyderabad
500 078
India

Charity

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

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/08/2009		Yes	No