NCT02584816

Brief Summary

This is a Phase 3, open-label, randomized study to evaluate lot-to-lot consistency in the manufacture of Bovine Rotavirus Pentavalent Vaccine (BRV-PV).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,500

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Nov 2015

Geographic Reach
1 country

10 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

First Submitted

Initial submission to the registry

October 6, 2015

Completed
17 days until next milestone

First Posted

Study publicly available on registry

October 23, 2015

Completed
9 days until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

September 11, 2018

Status Verified

September 1, 2018

Enrollment Period

1.4 years

First QC Date

October 6, 2015

Last Update Submit

September 7, 2018

Conditions

Rotavirus Gastroenteritis

Keywords

BRV-PVRotavirus vaccinelot-to-lot consistencyinterference with routine immunization

Outcome Measures

Primary Outcomes (2)

  • Rotavirus vaccine lots Immunogenicity

    Serum anti- rotavirus IgA antibody concentrations expressed as GMCs for the BRV-PV to demonstrate equivalence in lot consistency among three lots.

    Four weeks after the third dose of vaccination

  • Immunogenicity of UIP vaccines

    Four weeks after the third dose of vaccination

Secondary Outcomes (2)

  • Immediate adverse events and Solicited post -vaccination reactogenicity

    AEs within 30 minutes post-vaccination and post vacc reactogenicity during 7 days after each vaccination

  • Rotavirus Immunogenicity:

    Four weeks after the third dose of vaccination

Study Arms (4)

Group 1 - BRV-PV Lot A

EXPERIMENTAL

BRV-PV Lot A + DPT- HepB-Hib + OPV

Biological: BRV-PV Lot A + DPT-HepB-Hib + OPV

Group 2 - BRV-PV Lot B

EXPERIMENTAL

BRV-PV Lot B+ DPT- HepB-Hib + OPV

Biological: BRV-PV Lot B + DPT-HepB-Hib + OPV

Group 3 - BRV-PV Lot C

EXPERIMENTAL

BRV-PV Lot C + DPT- HepB-Hib + OPV

Biological: BRV-PV Lot C + DPT-HepB-Hib + OPV

Group 4 - ROTARIX

ACTIVE COMPARATOR

ROTARIX + DPT-HepB-Hib + OPV

Biological: ROTARIX + DPT-HepB-Hib + OPV

Interventions

BRV-PV Lot A + DPT-HepB-Hib + OPVBIOLOGICAL

Dose 1: 6-8 weeks, Dose 2: 10 week, Dose 3: 14 week

Group 1 - BRV-PV Lot A
BRV-PV Lot B + DPT-HepB-Hib + OPVBIOLOGICAL

Dose 1: 6-8 weeks, Dose 2: 10 week, Dose 3: 14 week

Also known as: Live Attenuated human-bovine reassortant pentavalent rotavirus vaccine
Group 2 - BRV-PV Lot B
BRV-PV Lot C + DPT-HepB-Hib + OPVBIOLOGICAL

Dose 1: 6-8 weeks, Dose 2: 10 week, Dose 3: 14 week

Group 3 - BRV-PV Lot C
ROTARIX + DPT-HepB-Hib + OPVBIOLOGICAL

Dose 1: 6-8 weeks, Dose 2: 10 week, Dose 3: 14 week (Third dose-Placebo)

Group 4 - ROTARIX

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 written informed consent.
  • Parent who intends to remain in the area with the child during the study period.
  • Receipt of birth dose of Hepatitis B vaccine and OPV.

You may not qualify if:

  • Concurrent participation in another clinical trial at any point throughout the entire timeframe for this study.
  • Presence of significant malnutrition or any systemic disorder 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 or intent to receive rotavirus and / or diphtheria, tetanus, pertussis, Haemophilus Influenzae type b, Hepatitis B vaccine (other than birth dose) or inactivated polio vaccine (IPV) during the study period and outside of the study. OPV dose received during national / subnational immunization days will be allowed.
  • A known sensitivity or allergy to any components of the study vaccine.
  • Clinically detectable congenital or genetic defect.
  • History of persistent diarrhea (defined as diarrhea that lasts 14 days or longer).
  • Receipt of 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 written informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Gandhi Medical College and Gandhi Hospital

Hyderabad, Andhra Pradesh, 500020, India

Location

King George Hospital

Visakhapatnam, Andhra Pradesh, 530002, India

Location

JSS Medical College and Hospital

Mysore, Karnataka, 570004, India

Location

T. N. Medical College and B. Y. L. Nair Charitable

Mumbai, Maharashtra, 400008, India

Location

Seth G S Medical College & KEM Hospital

Mumbai, Maharashtra, 400012, India

Location

Bharati Vidyapeeth Medical College and Hospital

Pune, Maharashtra, 411043, India

Location

KEM Hospital and Research Centre, Vadu

Pune, Maharashtra, 412216, India

Location

Sri Ramachandra Medical Centre

Chennai, Tamil Nadu, 600116, India

Location

Institute of Child Health

Kolkata, West Bengal, 700017, India

Location

Maulana Azad Medical College

New Delhi, India

Location

Related Publications (1)

  • Desai S, Rathi N, Kawade A, Venkatramanan P, Kundu R, Lalwani SK, Dubey AP, Venkateswara Rao J, Narayanappa D, Ghildiyal R, Gogtay NJ, Venugopal P, Palkar S, Munshi R, Bavdekar A, Juvekar S, Ganguly N, Niyogi P, Uttam KG, Kondekar A, Kumbhar D, Mohanlal S, Agarwal MC, Shetty P, Antony K, Gunale B, Dharmadhikari A, Deshpande J, Nalavade U, Sharma D, Bansal A, Tang Y, Flores J, Kulkarni PS. Non-interference of Bovine-Human reassortant pentavalent rotavirus vaccine ROTASIIL(R) with the immunogenicity of infant vaccines in comparison with a licensed rotavirus vaccine. Vaccine. 2018 Sep 5;36(37):5519-5523. doi: 10.1016/j.vaccine.2018.07.064. Epub 2018 Aug 10.

    PMID: 30104114RESULT

Related Links

MeSH Terms

Interventions

Poliovirus Vaccine, OralRIX4414 vaccine

Intervention Hierarchy (Ancestors)

Poliovirus VaccinesViral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • Dr Prasad Kulkarni, M.D.

    Serum Institute of India Pvt. Ltd.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 6, 2015

First Posted

October 23, 2015

Study Start

November 1, 2015

Primary Completion

April 1, 2017

Study Completion

June 1, 2017

Last Updated

September 11, 2018

Record last verified: 2018-09

Locations

IN(10)