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
1 other identifier
interventional
1,500
1 country
8
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2017
Shorter than P25 for phase_2
8 active sites
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
October 30, 2017
CompletedFirst Submitted
Initial submission to the registry
February 11, 2018
CompletedFirst Posted
Study publicly available on registry
March 22, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 25, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 25, 2018
CompletedSeptember 10, 2018
September 1, 2018
8 months
February 11, 2018
September 7, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Immunogenicity Endpoints
28 days post dose 3
Immunogenicity Endpoints
28 days post dose 3
Study Arms (4)
LBRV-PV Lot A
EXPERIMENTALThe study participants in this arm will receive one of the three liquid rotavirus vaccine lots (LBRV-PV Lot A).
LBRV-PV Lot B
EXPERIMENTALThe study participants in this arm will receive one of the three liquid rotavirus vaccine lots (LBRV-PV Lot B).
LBRV-PV Lot C
EXPERIMENTALThe study participants in this arm will receive one of the three liquid rotavirus vaccine lots (LBRV-PV Lot C).
ROTASIIL
ACTIVE COMPARATORThe study participants in this arm will receive ROTASIIL, the licensed lyophilized rotavirus vaccine in India.
Interventions
Liquid Rotavirus Vaccine and Lyophilized Rotavirus Vaccine
Eligibility Criteria
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:
- Presence of diarrhea or vomiting in the previous 72 hours or on the day of enrollment.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Centre for Vaccine Studies, Prasanna School of Public Health, Manipal University, Manipal,
Udupi, Karnataka, 576104, India
KEM Hospital Research Centre
Pune, Maharashtra, 411028, India
Bharati Vidyapeeth Medical College and Hospital, Pune
Pune, Maharashtra, 411043, India
Department of community Medicine, Dr Sushila Nayar School of Public Health, Mahatma Gandhi Institute of Medical Sciences, Sewagram
Wardha, Maharashtra, 442102, India
Hakeem Abdul Hameed Centenary Hospital
New Delhi, National Capital Territory of Delhi, India
Sri Ramachandra Medical Centre, Chennai
Chennai, Tamil Nadu, 600116, India
Institute of Child Health, Kolkata
Kolkata, West Bengal, 700017, India
Post Graduate Institute of Medical Education and Research, Chandigarh
Chandigarh, 160012, India
Related Publications (1)
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.
PMID: 30955982DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 11, 2018
First Posted
March 22, 2018
Study Start
October 30, 2017
Primary Completion
June 25, 2018
Study Completion
June 25, 2018
Last Updated
September 10, 2018
Record last verified: 2018-09
Data Sharing
- IPD Sharing
- Will not share