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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

S

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)

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

Trial contacts and locations

8

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Data sourced from clinicaltrials.gov

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