NCT01305109

A Phase III Clinical Trial to Evaluate the Protective Efficacy of Three Doses of Oral Rotavirus Vaccine (ORV) 116E

A Phase III, Randomized, Double Blind, Placebo Controlled Trial to Evaluate the Protective Efficacy of Three Doses of Oral Rotavirus Vaccine (ORV) 116E, Against Severe Rotavirus Gastroenteritis in Infants

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 6,800 (estimated)
• Sponsor: Bharat Biotech International Limited · Industry
• Sex: All
• Age: 6 Weeks – 7 Weeks
• Healthy volunteers: Accepted

Summary

The trial is a phase III randomized, double-blind, placebo-controlled trial with the primary objective of evaluating the efficacy of three doses of ORV 116E, 10\^5.0 FFU, against severe rotavirus gastroenteritis, in comparison with a placebo in India.

Detailed description

The trial is a phase III randomized, double-blind, placebo-controlled trial with the primary objective of evaluating the efficacy of three doses of ORV 116E, 10\^5.0 FFU, against severe rotavirus gastroenteritis, in comparison with a placebo in India. The clinical trial is not a global trial. Three administrations of ORV 116E will be co-administered with childhood vaccines (which will include vaccines against diphtheria, pertussis, tetanus, Haemophilus influenzae B and Hepatitis B and OPV) at 6 to 7 weeks, greater than or equal to 10 weeks and greater than or equal to 14 weeks of age. 6800 subjects will be enrolled in three sites - Delhi, Pune (Maharashtra) and Vellore (Tamil Nadu) and followed up till the age of 2 years (24 months + up to 14 days). Multiple trial sites are included to ensure greater demographic distribution to obtain evidence of cross immunity and quicker recruitment of the necessary number of subjects. The subjects to be included from these sites would be representative of the population of India. The protocol has been reviewed by the institutional review boards of the Society for Applied Studies (New Delhi), KEM Hospital Research Centre (Pune), Christian Medical College (Vellore). Ethics clearance has also been obtained from the Department of Biotechnology, Government of India and Western Institutional Review Board.

Conditions

• Viral Gastroenteritis Due to Rotavirus

Interventions

Type	Name	Description
BIOLOGICAL	ORV 116E	Oral Rotavirus Vaccine 116E (ORV 116E), 10\^5.0 FFU of Bharat Biotech International Limited, 3 doses of 0.5mL at 4 week intervals
BIOLOGICAL	Placebo	3 doses of 0.5 mL at 4 week intervals

Timeline

• Start date: 2011-03-01
• Primary completion: 2013-12-01
• Completion: 2014-04-01
• First posted: 2011-02-28
• Last updated: 2012-06-12

Locations

3 sites across 1 country: India