Overview

This trial is active, not recruiting.

Condition viral gastroenteritis due to rotavirus
Treatments orv 116e, placebo
Phase phase 3
Sponsor Bharat Biotech International Limited
Collaborator Ministry of Science and Technology, India
Start date March 2011
End date December 2013
Trial size 6800 participants
Trial identifier NCT01305109, BBIL/ROTA/021, Clinical Trials Registry-India

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose prevention
Arm
(Experimental)
Oral Rotavirus Vaccine 116E (ORV 116E), 10^5.0 FFU of Bharat Biotech International Limited, 3 doses of 0.5 mL at 4 week intervals
orv 116e ROTAVAC
Oral Rotavirus Vaccine 116E (ORV 116E), 10^5.0 FFU of Bharat Biotech International Limited, 3 doses of 0.5mL at 4 week intervals
(Placebo Comparator)
3 doses of 0.5 mL at 4 week intervals
placebo Placebo
3 doses of 0.5 mL at 4 week intervals

Primary Outcomes

Measure
Efficacy against severe rotavirus gastroenteritis (>=11 on the 20 point Vesikari scoring scale) caused by non vaccine rotavirus
time frame: Up to 2 years of age

Secondary Outcomes

Measure
Efficacy against severe rotavirus gastroenteritis (>=11 on the 20 point Vesikari scoring scale) caused by non vaccine rotavirus
time frame: Up to 1 year of age
Efficacy against severe rotavirus gastroenteritis (>=11 on the 20 point Vesikari scoring scale) caused by non vaccine rotavirus
time frame: From the age of 12 months till the age of 2 years of age
Efficacy against severe rotavirus gastroenteritis (>=11 on the 20 point Vesikari scoring scale) caused by non vaccine rotavirus in intent-to-treat population
time frame: Up to 2 years of age
Efficacy against any severity of gastroenteritis caused by a non vaccine rotavirus
time frame: Up to 2 years of age
Efficacy against any severity of gastroenteritis irrespective of etiology
time frame: Up to 2 years of Age
Efficacy against severe (>=11 on the 20 point Vesikari scoring scale) gastroenteritis irrespective of etiology
time frame: Up to 2 years of age
Efficacy to prevent hospitalization and/or supervised rehydration therapy (equivalent to WHO plan B or C) in a treatment facility/hospital for gastroenteritis caused by non vaccine rotavirus
time frame: Up to 2 years of age
Efficacy to prevent hospitalization and/or supervised rehydration therapy (equivalent to WHO plan B or C) in a treatment facility/hospital for gastroenteritis of any etiology
time frame: Up to 2 years of age
Efficacy to prevent hospitalization and/or supervised re-hydration therapy (equivalent to WHO plan B or C) in a treatment facility/hospital for severe gastroenteritis caused by non vaccine rotavirus
time frame: Up to 2 years of age
Efficacy to prevent hospitalization and/or supervised re-hydration therapy (equivalent to WHO plan B or C) in a treatment facility/hospital for severe gastroenteritis of any etiology
time frame: Up to 2 years of age
Efficacy against very severe rotavirus gastroenteritis (≥16 on the 20-point Vesikari scoring system) caused by non vaccine rotavirus
time frame: Up to 2 years of age
Safety of ORV 116E for immediate adverse events and serious adverse events in comparison to a placebo
time frame: Up to 2 years of age
Safety of ORV 116E for adverse events in a subset
time frame: 2 weeks period following each administration
Safety of ORV 116E for intussusception events
time frame: Up to 2 years of age
Immunogenicity rates to three doses of the ORV 116E and vaccine virus shedding rates after each of the three doses of the ORV 116E in a subset
time frame: 28 days after administration of third dose

Eligibility Criteria

Male or female participants from 6 weeks up to 7 weeks old.

Inclusion Criteria: - At least one parent(s) or legally acceptable representative's consent for participation and are able to understand study procedures - Subjects aged 6 to 7 weeks at recruitment - No plans to move in the next 24 months Exclusion Criteria: - Administration of rotavirus vaccine in the past - Presence of any illness requiring hospital referral (temporary exclusion) - Known case of immunodeficiency disease, known HIV positive - Known case of chronic gastroenteritis disease - Any other conditions which in the judgment of the investigator warrant exclusion (e.g. no exclusion criteria but seems "ill", investigators suspects neglect) - Diarrhea on the day of enrollment (temporary exclusion)

Additional Information

Official title 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
Principal investigator Dr. Temsunaro R Chandola, MD, MSc
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2012.
Information provided to ClinicalTrials.gov by Bharat Biotech International Limited.