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Completed

NCT Number: NCT03474055

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

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.

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Key information

Conditions

Rotavirus Gastroenteritis Diarrhea Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

6 week–8 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Centre for Vaccine Studies, Prasanna School of Public Health, Manipal University, Manipal,, Udupi, Karnataka, India

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Presence of diarrhea or vomiting in the previous 72 hours or on the day of enrollment.
  • Acute disease at the time of enrollment (temporary exclusion)
  • Concurrent participation in another clinical trial at any point throughout the entire time frame for this study
  • History of congenital abdominal disorders, intussusception, or abdominal surgery.
  • Known or suspected impairment of immunological function based on medical history and physical examination.
  • 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.

Treatment and study plan

Liquid Rotavirus Vaccine

Biological

Liquid Rotavirus Vaccine and Lyophilized Rotavirus Vaccine

Other names: ROTASIIL

Primary outcomes

  1. Immunogenicity of rotavirus vaccine

    Time frame: 28 days post dose 3

    Serum anti- rotavirus IgA antibody concentrations expressed as GMCs for the comparison of LBRV-PV vaccine and ROTASIIL

Secondary outcomes

  1. Immunogenicity Endpoints

    Time frame: 28 days post dose 3

    GMCs of serum anti- rotavirus IgA antibody among the LBRV-PV lots at four weeks after the third vaccination.

  2. Immunogenicity Endpoints

    Time frame: 28 days post dose 3

    Proportion of subjects achieving IgA antibody concentration ≥20 U/ml for the comparison of LBRV-PV and ROTASIIL.

Sponsors and collaborators

Lead sponsor

Serum Institute of India Pvt. Ltd.

Industry

Registry information

Official study title

A Phase II/III, Multicenter, Open-Label, Randomized Study of 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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 22, 2018
Registry last updated
Sep 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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