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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Bharat Biotech International Limited.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Ministry of Science and Technology, India
PATH
Information provided by (Responsible Party):
Bharat Biotech International Limited
ClinicalTrials.gov Identifier:
NCT01305109
First received: February 18, 2011
Last updated: June 9, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
Viral Gastroenteritis Due to Rotavirus
Biological: ORV 116E
Biological: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Bharat Biotech International Limited:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 occurring at least 14 days following the third dose till the age of 12 months + up to 14 days

  • 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 ] [ Designated as safety issue: No ]
    Efficacy of ORV 116E will be assessed in comparison to a placebo for severe rotavirus gastroenteritis (>=11 on the 20 point Vesikari scoring scale) caused by non vaccine rotavirus occurring from the age of 12 months till the age of 2 years (24 months) + up to 14 days

  • 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 ] [ Designated as safety issue: No ]
    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 the intent-to-treat population till the age of 2 years (24 months) + up to 14 days.

  • Efficacy against any severity of gastroenteritis caused by a non vaccine rotavirus [ Time Frame: Up to 2 years of age ] [ Designated as safety issue: No ]
    Efficacy of ORV 116E will be assessed in comparison to a placebo for any severity of gastroenteritis caused by non vaccine rotavirus from 14 days following the 3rd dose till the age of 2 years (24 months) + up to 14 days

  • Efficacy against any severity of gastroenteritis irrespective of etiology [ Time Frame: Up to 2 years of Age ] [ Designated as safety issue: No ]
    Efficacy of ORV 116E will be assessed in comparison to a placebo for any severity of gastroenteritis irrespective of etiology from 14 days following the 3rd dose till the age of 2 years (24 months) + up to 14 days

  • Efficacy against severe (>=11 on the 20 point Vesikari scoring scale) gastroenteritis irrespective of etiology [ Time Frame: Up to 2 years of age ] [ Designated as safety issue: No ]
    Efficacy of ORV 116E will be assessed in comparison to a placebo for severe (≥11 on the 20 point Vesikari scoring scale) gastroenteritis irrespective of etiology from 14 days following the 3rd dose till the age of 2 years (24 months) + up to 14 days

  • 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 ] [ Designated as safety issue: No ]
    Efficacy of ORV 116E will be assessed in comparison to a placebo to prevent hospitalization and/or supervised re-hydration therapy (equivalent to WHO plan B or C) in a treatment facility/hospital for gastroenteritis caused by non vaccine rotavirus from 14 days following the 3rd dose till the age of 2 years (24 months) + up to 14 days

  • 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 ] [ Designated as safety issue: No ]
    Efficacy of ORV 116E will be assessed in comparison to a placebo to prevent hospitalization and/or supervised re-hydration therapy (equivalent to WHO plan B or C) in a treatment facility/hospital for gastroenteritis of any etiology from 14 days following the 3rd dose till the age of 2 years (24 months) + up to 14 days

  • 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 ] [ Designated as safety issue: No ]
    Efficacy of ORV 116E will be assessed in comparison to a placebo 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 from 14 days following the 3rd dose till the age of 2 years (24 months) + up to 14 days

  • 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 ] [ Designated as safety issue: No ]
    Efficacy of ORV 116E will be assessed in comparison to a placebo 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 from 14 days following the 3rd dose till the age of 2 years (24 months) + up to 14 days

  • 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 ] [ Designated as safety issue: No ]
    Efficacy of ORV 116E will be assessed in comparison to placebo against very severe rotavirus gastroenteritis (≥16 on the 20-point Vesikari scoring system) caused by non vaccine rotavirus from 14 days following the 3rd dose till the age of 2 years (24 months) + up to 14 days

  • 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 ] [ Designated as safety issue: Yes ]
    Safety of ORV 116E for immediate adverse events and serious adverse events in comparison to a placebo will be assessed in all the subjects, from day of 1st dose till the age of 2 years (24 months) + up to 14 days.

  • Safety of ORV 116E for adverse events in a subset [ Time Frame: 2 weeks period following each administration ] [ Designated as safety issue: Yes ]
    Safety of ORV 116E for adverse events assessed daily in the 2 week period following each dose in comparison to a placebo in first one third of the enrolled subjects in all the three sites

  • Safety of ORV 116E for intussusception events [ Time Frame: Up to 2 years of age ] [ Designated as safety issue: Yes ]
    Safety of ORV 116E for intussusception events in comparison to a placebo will be assessed in all subjects, from day of 1st dose till the age of 2 years (24 months) + up to 14 days

  • 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 ] [ Designated as safety issue: No ]
    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 comparison to a placebo will be ascertained in approximately 150 subjects at each site.


Estimated Enrollment: 6800
Study Start Date: March 2011
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
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 Name: ROTAVAC
Placebo Comparator: Placebo
3 doses of 0.5 mL at 4 week intervals
Biological: Placebo
3 doses of 0.5 mL at 4 week intervals
Other Name: Placebo

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.

  Eligibility

Ages Eligible for Study:   6 Weeks to 7 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01305109

Locations
India
Shirdi Sai Baba Rural Hospital, KEM Hospital Research Centre,Vadu Rural Health
Pune, Maharashtra, India, 412216
Centre for Health Research and Development, Society for Applied Studies
New Delhi, India, 110 062
Christian Medical College
Vellore, India, 632004
Sponsors and Collaborators
Bharat Biotech International Limited
Ministry of Science and Technology, India
PATH
Investigators
Principal Investigator: 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
  More Information

No publications provided by Bharat Biotech International Limited

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bharat Biotech International Limited
ClinicalTrials.gov Identifier: NCT01305109     History of Changes
Other Study ID Numbers: BBIL/ROTA/021, Clinical Trials Registry-India
Study First Received: February 18, 2011
Last Updated: June 9, 2012
Health Authority: India: Drugs Controller General of India

Additional relevant MeSH terms:
Gastroenteritis
Enteritis
Adenovirus Infections, Human
Enterovirus Infections
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Adenoviridae Infections
DNA Virus Infections
Virus Diseases
Picornaviridae Infections
RNA Virus Infections

ClinicalTrials.gov processed this record on August 01, 2014