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

Serum Institute of India

Status and phase: Completed; Phase 3; Phase 2

Conditions: Rotavirus Gastroenteritis

Treatments: Biological: Liquid Rotavirus Vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT03474055

ROTA:06

Details and patient eligibility

About

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.

Enrollment: 1,500 patients

Sex: All

Ages: 6 to 8 weeks old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,500 participants in 4 patient groups

LBRV-PV Lot A

Experimental group

Description:

The study participants in this arm will receive one of the three liquid rotavirus vaccine lots (LBRV-PV Lot A).

Treatment:

Biological: Liquid Rotavirus Vaccine

LBRV-PV Lot B

Experimental group

Description:

The study participants in this arm will receive one of the three liquid rotavirus vaccine lots (LBRV-PV Lot B).

Treatment:

Biological: Liquid Rotavirus Vaccine

LBRV-PV Lot C

Experimental group

Description:

The study participants in this arm will receive one of the three liquid rotavirus vaccine lots (LBRV-PV Lot C).

Treatment:

Biological: Liquid Rotavirus Vaccine

ROTASIIL

Active Comparator group

Description:

The study participants in this arm will receive ROTASIIL, the licensed lyophilized rotavirus vaccine in India.

Treatment:

Biological: Liquid Rotavirus Vaccine