NCT02133690

Brief Summary

This is a Phase 3 multicentre, randomized, double blind, placebo-controlled study to determine the effectiveness of the rotavirus vaccine.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
7,500

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started May 2014

Typical duration for phase_3

Geographic Reach
1 country

6 active sites

Status
completed

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

Study Start

First participant enrolled

May 1, 2014

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

May 6, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 8, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

September 10, 2018

Status Verified

September 1, 2018

Enrollment Period

1.8 years

First QC Date

May 6, 2014

Last Update Submit

September 6, 2018

Conditions

Rotavirus Gastroenteritis

Keywords

rotavirusrotavirus vaccineBRV-PV

Outcome Measures

Primary Outcomes (1)

  • occurrence of Severe Rotavirus Gastroenteritis

    Laboratory confirmed cases of severe rotavirus gastroenteritis occurring in infants receiving the complete vaccination regimen occurring from 14 days after the third vaccine dose until 122 cases are accrued, or until all participating infants reach two years of age (per protocol analysis).

    Up to 2 years of age of participants

Secondary Outcomes (1)

  • Safety

    Until completion of 2 years age of participant

Study Arms (2)

Vaccine Arm

EXPERIMENTAL

3 doses, 4 weeks apart, of Live Attenuated Pentavalent (G1-G2-G3-G4-G9) Human X Bovine Reassortant Rotavirus Vaccine (BRV-PV), at a dosage of ≥ Log10\^5.6 fluorescent focus units (FFU)/Serotype/Dose in 2.5 ml of buffered diluent

Biological: Live Attenuated Pentavalent (G1-G2-G3-G4-G9) Human X Bovine Reassortant Rotavirus Vaccine (BRV-PV)

Placebo group

PLACEBO COMPARATOR

3 doses, 4 weeks apart, of Lyophilized minimal essential medium (MEM) + excipients reconstituted in 2.5 ml of buffered diluents

Other: Placebo

Interventions

Live Attenuated Pentavalent (G1-G2-G3-G4-G9) Human X Bovine Reassortant Rotavirus Vaccine (BRV-PV)BIOLOGICAL

Live Attenuated Pentavalent (G1-G2-G3-G4-G9) Human X Bovine Reassortant Rotavirus Vaccine (BRV-PV), at a dosage of ≥ Log10\^5.6 fluorescent focus units (FFU)/Serotype/Dose in 2.5 ml of buffered diluent

Vaccine Arm
PlaceboOTHER

Lyophilized minimal essential medium (MEM) + excipients reconstituted in 2.5 ml of buffered diluents

Placebo group

Eligibility Criteria

Age6 Weeks - 8 Weeks
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Healthy infants as established by medical history and clinical examination before entering the study.
  • Age: 6-8 weeks at the time of enrollment.
  • Parental ability and willingness to provide informed consent.
  • Parent who intends to remain in the area with the child during the study period.

You may not qualify if:

  • Concurrent participation in another clinical trial throughout the entire timeframe for this study.
  • Presence of significant malnutrition (weight-for-height z-score \<-3SD median) or any systemic disorder (cardiovascular, pulmonary, hepatic, renal, gastrointestinal, hematological, endocrine, immunological, dermatological, neurological, cancer or autoimmune disease) as determined by medical history and/or physical examination which would compromise the subject's health or is likely to result in nonconformance to the protocol. History of congenital abdominal disorders, intussusception or abdominal surgery
  • Known or suspected impairment of immunological function based on medical history and physical examination.
  • Household contact with an immunosuppressed individual or pregnant woman.
  • Prior receipt of rotavirus vaccine.
  • A known sensitivity or allergy to any components of the study vaccine.
  • Major congenital or genetic defect.
  • History of persistent diarrhea (defined as diarrhea more than 14 days).
  • Participant's parents not able, available or willing to accept active weekly follow-up by the study staff.
  • Has received any immunoglobulin therapy and/or blood products since birth or planned administration during the study period.
  • History of chronic administration (defined as more than 14 days) of immunosuppressants including corticosteroids. Infants on inhaled or topical steroids may be permitted to participate in the study.
  • History of any neurologic disorders or seizures.
  • Any medical condition in the parents/infant which, in the judgment of the investigator, would interfere with or serves as a contraindication to protocol adherence or a participant's parents' ability to give informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Dr Dinesh Kumar Government Medical College, Jammu Department of Community Medicine, Government Medical College

Jammu, Jammu and Kashmir, India

Location

Kasturba Medical College, Manipal

Manipal, Karnataka, India

Location

KEM Hospital and Research Centre

Pune, Maharashtra, India

Location

Dr. Sushila Nayar School of Public Health ,Mahatma Ghandi School of Medicine

Sewāgrām, Maharashtra, India

Location

Center for Health Research and Development (CHRD) -Society for applied studies (SAS)

New Delhi, National Capital Territory of Delhi, India

Location

National Institute of Cholera & Enteric Diseases

Kolkata, West Bengal, India

Location

Related Publications (1)

  • Kulkarni PS, Desai S, Tewari T, Kawade A, Goyal N, Garg BS, Kumar D, Kanungo S, Kamat V, Kang G, Bavdekar A, Babji S, Juvekar S, Manna B, Dutta S, Angurana R, Dewan D, Dharmadhikari A, Zade JK, Dhere RM, Fix A, Power M, Uprety V, Parulekar V, Cho I, Chandola TR, Kedia VK, Raut A, Flores J; SII BRV-PV author group. A randomized Phase III clinical trial to assess the efficacy of a bovine-human reassortant pentavalent rotavirus vaccine in Indian infants. Vaccine. 2017 Oct 27;35(45):6228-6237. doi: 10.1016/j.vaccine.2017.09.014. Epub 2017 Sep 26.

    PMID: 28967523RESULT

Related Links

Study Officials

  • Prasad Kulkarni, MD

    Serum Institute of India Pvt. Ltd.

    STUDY DIRECTOR

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

May 6, 2014

First Posted

May 8, 2014

Study Start

May 1, 2014

Primary Completion

March 1, 2016

Study Completion

March 1, 2017

Last Updated

September 10, 2018

Record last verified: 2018-09

Locations

IN(6)