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

NCT ID: NCT01305109

Last Updated: 2012-06-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 6800 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2014-04-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Oral Rotavirus Vaccine 116E (ORV 116E)

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

Group Type: EXPERIMENTAL

ORV 116E

Intervention Type: BIOLOGICAL

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

3 doses of 0.5 mL at 4 week intervals

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

3 doses of 0.5 mL at 4 week intervals

Interventions

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

Intervention Type: BIOLOGICAL

Placebo

3 doses of 0.5 mL at 4 week intervals

Intervention Type: BIOLOGICAL

Other Intervention Names

ROTAVAC

Eligibility 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
• Diarrhea on the day of enrollment (temporary exclusion)

• Minimum Eligible Age: 6 Weeks
• Maximum Eligible Age: 7 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ministry of Science and Technology, India

OTHER_GOV

Sponsor Role: collaborator

PATH

OTHER

Sponsor Role: collaborator

Bharat Biotech International Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dr. Temsunaro R Chandola, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Centre for Health Research and Development, Society for Applied Studies

Gagandeep Kang, MDFRCPathPhD

Role: PRINCIPAL_INVESTIGATOR

Christian Medical College, Vellore, India

Ashish Bavdekar, MD,DCH,DNB

Role: PRINCIPAL_INVESTIGATOR

Shirdi Sai Baba Rural Hospital, KEM Hospital Research Centre,Vadu Rural Health

Locations

Shirdi Sai Baba Rural Hospital, KEM Hospital Research Centre,Vadu Rural Health

Pune, Maharashtra, India

Centre for Health Research and Development, Society for Applied Studies

New Delhi, New Delhi, India

Christian Medical College

Vellore, , India

Countries

India

References

Bhandari N, Rongsen-Chandola T, Bavdekar A, John J, Antony K, Taneja S, Goyal N, Kawade A, Kang G, Rathore SS, Juvekar S, Muliyil J, Arya A, Shaikh H, Abraham V, Vrati S, Proschan M, Kohberger R, Thiry G, Glass R, Greenberg HB, Curlin G, Mohan K, Harshavardhan GV, Prasad S, Rao TS, Boslego J, Bhan MK; India Rotavirus Vaccine Group. Efficacy of a monovalent human-bovine (116E) rotavirus vaccine in Indian children in the second year of life. Vaccine. 2014 Aug 11;32 Suppl 1:A110-6. doi: 10.1016/j.vaccine.2014.04.079.

Reference Type: DERIVED

PMID: 25091663 (View on PubMed)

Bhandari N, Rongsen-Chandola T, Bavdekar A, John J, Antony K, Taneja S, Goyal N, Kawade A, Kang G, Rathore SS, Juvekar S, Muliyil J, Arya A, Shaikh H, Abraham V, Vrati S, Proschan M, Kohberger R, Thiry G, Glass R, Greenberg HB, Curlin G, Mohan K, Harshavardhan GV, Prasad S, Rao TS, Boslego J, Bhan MK; India Rotavirus Vaccine Group. Efficacy of a monovalent human-bovine (116E) rotavirus vaccine in Indian infants: a randomised, double-blind, placebo-controlled trial. Lancet. 2014 Jun 21;383(9935):2136-43. doi: 10.1016/S0140-6736(13)62630-6. Epub 2014 Mar 12.

Reference Type: DERIVED

PMID: 24629994 (View on PubMed)

Other Identifiers

Clinical Trials Registry-India

Identifier Type: REGISTRY

Identifier Source: secondary_id

BBIL/ROTA/021

Identifier Type: -

Identifier Source: org_study_id