Clinical trial 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
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Rotavirus Gastroenteritis
Keywords: Liquid rotavirus vaccine
LBRV-PV
Gastroenteritis
Diarrhoea
Lead sponsor: Serum Institute of India Pvt. Ltd.
Sponsor class: INDUSTRY
First posted: 2018-03-22
Enrollment: 1500
Sex: ALL
Minimum age (years): 6
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Immunogenicity of rotavirus vaccine
timeFrame: 28 days post dose 3
Secondary outcomes:
measure: Immunogenicity Endpoints
timeFrame: 28 days post dose 3
measure: Immunogenicity Endpoints
timeFrame: 28 days post dose 3
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Hakeem Abdul Hameed Centenary Hospital
state: Delhi
city: Udupi
country: India
facility: Centre for Vaccine Studies, Prasanna School of Public Health, Manipal University, Manipal,
state: Karnataka
city: Pune
country: India
facility: KEM Hospital Research Centre
state: Maharashtra
city: Pune
country: India
facility: Bharati Vidyapeeth Medical College and Hospital, Pune
state: Maharashtra
city: Wardha
country: India
facility: Department of community Medicine, Dr Sushila Nayar School of Public Health, Mahatma Gandhi Institute of Medical Sciences, Sewagram
state: Maharashtra
city: Chennai
country: India
facility: Sri Ramachandra Medical Centre, Chennai
state: Tamil Nadu
city: Kolkata
country: India
facility: Institute of Child Health, Kolkata
state: West Bengal
city: Chandigarh
country: India
facility: Post Graduate Institute of Medical Education and Research, Chandigarh
Study officials:
References:
citation: 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.