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

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03474055

Enrollment

1500

Registered

2018-03-22

Start date

2017-10-30

Completion date

2018-06-25

Last updated

2018-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rotavirus Gastroenteritis

Keywords

Liquid rotavirus vaccine, LBRV-PV, Gastroenteritis, Diarrhoea

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.

Interventions

BIOLOGICALLiquid Rotavirus Vaccine

Liquid Rotavirus Vaccine and Lyophilized Rotavirus Vaccine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

6 Weeks to 8 Weeks

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Immunogenicity of rotavirus vaccine	28 days post dose 3	Serum anti- rotavirus IgA antibody concentrations expressed as GMCs for the comparison of LBRV-PV vaccine and ROTASIIL

Secondary

Measure	Time frame	Description
Immunogenicity Endpoints	28 days post dose 3	GMCs of serum anti- rotavirus IgA antibody among the LBRV-PV lots at four weeks after the third vaccination.

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026