Trial | NCT01305109  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    6800
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 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.
Study Started
Mar 31
2011
Primary Completion
Dec 31
2013
Anticipated
Study Completion
Apr 30
2014
Anticipated
Last Update
Jun 12
2012
Estimate

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

  • Other names: ROTAVAC

Biological Placebo

3 doses of 0.5 mL at 4 week intervals

Oral Rotavirus Vaccine 116E (ORV 116E) 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

Placebo Placebo Comparator

3 doses of 0.5 mL at 4 week intervals

Criteria 

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)
No Results Posted