NCT01305109

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
6,800

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Mar 2011

Typical duration for phase_3

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 18, 2011

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 28, 2011

Completed
1 day until next milestone

Study Start

First participant enrolled

March 1, 2011

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

June 12, 2012

Status Verified

June 1, 2012

Enrollment Period

2.8 years

First QC Date

February 18, 2011

Last Update Submit

June 9, 2012

Conditions

Viral Gastroenteritis Due to Rotavirus

Outcome Measures

Primary Outcomes (1)

  • Efficacy against severe rotavirus gastroenteritis (>=11 on the 20 point Vesikari scoring scale) caused by non vaccine rotavirus

    Efficacy of ORV 116E will be assessed in comparison to a placebo against severe rotavirus gastroenteritis (\>=11 on the 20 point Vesikari scoring scale) caused by non vaccine rotavirus in all subjects from 14 days following the 3rd dose till the age of 2 years (24 months) + up to 14 days.

    Up to 2 years of age

Secondary Outcomes (15)

  • Efficacy against severe rotavirus gastroenteritis (>=11 on the 20 point Vesikari scoring scale) caused by non vaccine rotavirus

    Up to 1 year of age

  • Efficacy against severe rotavirus gastroenteritis (>=11 on the 20 point Vesikari scoring scale) caused by non vaccine rotavirus

    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

    Up to 2 years of age

  • Efficacy against any severity of gastroenteritis caused by a non vaccine rotavirus

    Up to 2 years of age

  • Efficacy against any severity of gastroenteritis irrespective of etiology

    Up to 2 years of Age

  • +10 more secondary outcomes

Study Arms (2)

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

Biological: ORV 116E

Placebo

PLACEBO COMPARATOR

3 doses of 0.5 mL at 4 week intervals

Biological: Placebo

Interventions

ORV 116EBIOLOGICAL

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

Also known as: ROTAVAC
Oral Rotavirus Vaccine 116E (ORV 116E)
PlaceboBIOLOGICAL

3 doses of 0.5 mL at 4 week intervals

Placebo

Eligibility Criteria

Age6 Weeks - 7 Weeks
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • Administration of rotavirus vaccine in the past
  • Known case of immunodeficiency disease, known HIV positive
  • Known case of chronic gastroenteritis disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

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

Pune, Maharashtra, 412216, India

Location

Centre for Health Research and Development, Society for Applied Studies

New Delhi, New Delhi, 110 062, India

Location

Christian Medical College

Vellore, 632004, India

Location

Related Publications (2)

  • 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.

    PMID: 25091663DERIVED

  • 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.

    PMID: 24629994DERIVED

Study Officials

  • Dr. Temsunaro R Chandola, MD, MSc

    Centre for Health Research and Development, Society for Applied Studies

    PRINCIPAL INVESTIGATOR

  • Gagandeep Kang, MDFRCPathPhD

    Christian Medical College, Vellore, India

    PRINCIPAL INVESTIGATOR

  • Ashish Bavdekar, MD,DCH,DNB

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2011

First Posted

February 28, 2011

Study Start

March 1, 2011

Primary Completion

December 1, 2013

Study Completion

April 1, 2014

Last Updated

June 12, 2012

Record last verified: 2012-06

Locations

IN(3)