Study on Liquid Bovine Rotavirus Pentavalent Vaccine (LBRV-PV) to Evaluate Lot-to-Lot Consistency and to Compare Non-Inferiority With ROTASIIL (Lyophilized BRV-PV) in Healthy Infants in India

Last updated: September 7, 2018
Sponsor: Serum Institute of India Pvt. Ltd.
Overall Status: Completed

Phase

2/3

Condition

Gastroenteritis

Rotavirus

Infectious Colitis

Treatment

N/A

Clinical Study ID

NCT03474055
ROTA:06
  • Ages 6-8
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

This study has been designed to compare the liquid formulation of BRV-PV (LBRV-PV) with the lyophilized formulation (ROTASIIL) by testing the vaccine in infants (three doses administered 4 weeks apart, starting at 6-8 weeks of age) in order to demonstrate the non-inferiority in the induction of specific anti-rotavirus IgA antibodies by these vaccines. The study will also evaluate lot-to-lot consistency in the manufacture of LBRV-PV by demonstrating equivalence in the induction of specific anti-rotavirus IgA antibodies across three production lots.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Healthy infants as established by medical history and clinical examination beforeentering the study.

  2. Age: 6-8 weeks at the time of enrollment.

  3. Parental ability and willingness to provide informed consent.

  4. Parent who intends to remain in the area with the child during the study period.

Exclusion

Exclusion Criteria:

  1. Presence of diarrhea or vomiting in the previous 72 hours or on the day of enrollment.

  2. Acute disease at the time of enrollment (temporary exclusion)

  3. Concurrent participation in another clinical trial at any point throughout the entiretime frame for this study

  4. History of congenital abdominal disorders, intussusception, or abdominal surgery.

  5. Known or suspected impairment of immunological function based on medical history andphysical examination.

  6. History of any neurologic disorders or seizures.

  7. Any medical condition in the parents / infant which, in the judgment of theInvestigator, would interfere with or serves as a contraindication to protocoladherence or a participant's parents' ability to give informed consent.

Study Design

Total Participants: 1500
Study Start date:
October 30, 2017
Estimated Completion Date:
June 25, 2018

Connect with a study center

  • Hakeem Abdul Hameed Centenary Hospital

    New Delhi, Delhi
    India

    Site Not Available

  • Centre for Vaccine Studies, Prasanna School of Public Health, Manipal University, Manipal,

    Udupi, Karnataka 576104
    India

    Site Not Available

  • Bharati Vidyapeeth Medical College and Hospital, Pune

    Pune, Maharashtra 411043
    India

    Site Not Available

  • KEM Hospital Research Centre

    Pune, Maharashtra 411028
    India

    Site Not Available

  • Department of community Medicine, Dr Sushila Nayar School of Public Health, Mahatma Gandhi Institute of Medical Sciences, Sewagram

    Wardha, Maharashtra 442102
    India

    Site Not Available

  • Sri Ramachandra Medical Centre, Chennai

    Chennai, Tamil Nadu 600116
    India

    Site Not Available

  • Institute of Child Health, Kolkata

    Kolkata, West Bengal 700017
    India

    Site Not Available

  • Post Graduate Institute of Medical Education and Research, Chandigarh

    Chandigarh, 160012
    India

    Site Not Available

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