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

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

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.

Study Overview

• Status: Completed
• Conditions: Rotavirus Gastroenteritis
• Intervention / Treatment: Biological: Liquid Rotavirus Vaccine

• Study Type: Interventional
• Enrollment (Actual): 1500
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• India
  • Chandigarh, India, 160012
    • Post Graduate Institute of Medical Education and Research, Chandigarh
  • Delhi
    • New Delhi, Delhi, India
      • Hakeem Abdul Hameed Centenary Hospital
  • Karnataka
    • Udupi, Karnataka, India, 576104
      • Centre for Vaccine Studies, Prasanna School of Public Health, Manipal University, Manipal,
  • Maharashtra
    • Pune, Maharashtra, India, 411028
      • KEM Hospital Research Centre
    • Pune, Maharashtra, India, 411043
      • Bharati Vidyapeeth Medical College and Hospital, Pune
    • Wardha, Maharashtra, India, 442102
      • Department of community Medicine, Dr Sushila Nayar School of Public Health, Mahatma Gandhi Institute of Medical Sciences, Sewagram
  • Tamil Nadu
    • Chennai, Tamil Nadu, India, 600116
      • Sri Ramachandra Medical Centre, Chennai
  • West Bengal
    • Kolkata, West Bengal, India, 700017
      • Institute of Child Health, Kolkata

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 1 month (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Healthy infants as established by medical history and clinical examination before entering 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 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 entire time 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 and physical examination.
6. History of any neurologic disorders or seizures.
7. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LBRV-PV Lot A; The study participants in this arm will receive one of the three liquid rotavirus vaccine lots (LBRV-PV Lot A).	Biological: Liquid Rotavirus Vaccine; Liquid Rotavirus Vaccine and Lyophilized Rotavirus Vaccine; Other Names: ROTASIIL
Experimental: LBRV-PV Lot B; The study participants in this arm will receive one of the three liquid rotavirus vaccine lots (LBRV-PV Lot B).	Biological: Liquid Rotavirus Vaccine; Liquid Rotavirus Vaccine and Lyophilized Rotavirus Vaccine; Other Names: ROTASIIL
Experimental: LBRV-PV Lot C; The study participants in this arm will receive one of the three liquid rotavirus vaccine lots (LBRV-PV Lot C).	Biological: Liquid Rotavirus Vaccine; Liquid Rotavirus Vaccine and Lyophilized Rotavirus Vaccine; Other Names: ROTASIIL
Active Comparator: ROTASIIL; The study participants in this arm will receive ROTASIIL, the licensed lyophilized rotavirus vaccine in India.	Biological: Liquid Rotavirus Vaccine; Liquid Rotavirus Vaccine and Lyophilized Rotavirus Vaccine; Other Names: ROTASIIL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immunogenicity of rotavirus vaccine	Serum anti- rotavirus IgA antibody concentrations expressed as GMCs for the comparison of LBRV-PV vaccine and ROTASIIL	28 days post dose 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immunogenicity Endpoints	GMCs of serum anti- rotavirus IgA antibody among the LBRV-PV lots at four weeks after the third vaccination.	28 days post dose 3
Immunogenicity Endpoints	Proportion of subjects achieving IgA antibody concentration ≥20 U/ml for the comparison of LBRV-PV and ROTASIIL.	28 days post dose 3

Collaborators and Investigators

• Sponsor: Serum Institute of India Pvt. Ltd.

Publications and helpful links

General Publications

• Kawade A, Babji S, Kamath V, Raut A, Kumar CM, Kundu R, Venkatramanan P, Lalwani SK, Bavdekar A, Juvekar S, Dayma G, Patil R, Kulkarni M, Hegde A, Nayak D, Garg BS, Gupta S, Jategaonkar S, Bedi N, Maliye C, Ganguly N, Uttam KG, Niyogi P, Palkar S, Hanumante N, Goyal N, Arya A, Aslam M, Parulekar V, Dharmadhikari A, Gaikwad D, Zade J, Desai S, Kang G, Kulkarni PS. Immunogenicity and lot-to-lot consistency of a ready to use liquid bovine-human reassortant pentavalent rotavirus vaccine (ROTASIIL - Liquid) in Indian infants. Vaccine. 2019 May 1;37(19):2554-2560. doi: 10.1016/j.vaccine.2019.03.067. Epub 2019 Apr 4.

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2017
• Primary Completion (Actual): June 25, 2018
• Study Completion (Actual): June 25, 2018

Study Registration Dates

• First Submitted: February 11, 2018
• First Submitted That Met QC Criteria: March 21, 2018
• First Posted (Actual): March 22, 2018

Study Record Updates

• Last Update Posted (Actual): September 10, 2018
• Last Update Submitted That Met QC Criteria: September 7, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: Gastroenteritis; Diarrhoea; Liquid rotavirus vaccine; LBRV-PV
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis
• Other Study ID Numbers: ROTA:06

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No