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

Study Overview
=================
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.

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

Conditions
-----------------
Rotavirus Gastroenteritis

Intervention / Treatment
-----------------
* Biological: Liquid Rotavirus Vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 6 Weeks
Maximum Age: 8 Weeks

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Liquid rotavirus vaccine, LBRV-PV, Gastroenteritis, Diarrhoea