Clinical trial on Liquid Rotavirus vaccine to check consistency of different lots of vaccines manufactured and to compare vaccine non-inferiority with ROTASIIL vaccine in healthy children 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

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2017/10/010104

Enrollment

1500

Registered

2017-10-16

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

None listed

Interventions

Intervention1: LBRV-PV (Test Vaccine three lots): Liquid, ready to use formulation of live attenuated human-bovine reassortant pentavalent rotavirus vaccine (BRV-PV) based on the UK bovine rotavirus

Eligibility

Inclusion 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

Exclusion criteria: 1. Presence of diarrhea or vomiting in the previous 72 hours or on the day of enrollment (temporary exclusion). 2. Presence of fever on the day of enrollment (temporary exclusion). 3. Presence of acute disease at the time of enrollment (temporary exclusion). 4. Concurrent participation in another clinical trial at any point throughout the entire timeframe for this study.

Design outcomes

Primary

Measure	Time frame
â?¢ To demonstrate non-inferiority in the immunogenicity of LBRV-PV as compared with ROTASIIL (lyophilized BRV-PV) in infants.Timepoint: 28 days post dose 3	—

Secondary

Measure	Time frame
â?¢ To evaluate the safety of LBRV-PV in terms of immediate post-vaccination events, solicited reactions, unsolicited adverse events and serious adverse events, including monitoring for intussusception.Timepoint: Throughout the study period	—

Countries

India

Contacts

Public ContactDr Sajjad Desai

Serum Institute of India Pvt. Ltd.

drpsk@seruminstitute.com020-26602384

Outcome results