A clinical trial to study the effect and safety of Rotavirus Vaccine against Severe Rotavirus Gastroenteritis in healthy Indian Infants

Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate The Efficacy and Safety of Live Attenuated Bovine-Human Rotavirus Reassortant Pentavalent Vaccine (BRV-PV) against Severe Rotavirus Gastroenteritis in Healthy Indian Infants

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2013/05/003667

Enrollment

7500

Registered

2013-05-23

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: Rotavirus Vaccine: Three doses of BRV-PV will be administered concomitantly with UIP vaccines at 4 weeks intervals between doses (with a window of â??1 to +4 weeks). The first admini

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 3. Parent/legal guardian ability and willingness to provide informed consent. 4. Parent/legal guardian who intends to remain in the area with the child during the study period.

Exclusion criteria

Exclusion criteria: 1. Acute disease at the time of enrollment (temporary exclusion) 2. Concurrent participation in another clinical trial throughout the entire timeframe of this study. 3. History of congenital abdominal disorders, intussusception, abdominal surgery 4. Prior receipt of rotavirus vaccine. 5. Major congenital or genetic defect. 6. Participantâ??s parents not able, available or willing to accept active weekly follow-up by the study staff.

Design outcomes

Primary

Measure	Time frame
Cases of severe rotavirus gastroenteritis occurring in infants receiving the complete vaccination regimen occurring from 14 days after the third vaccine dose until all participating infants reach two years of age.Timepoint: 14th day after the third dose of vaccine administration	—

Secondary

Measure	Time frame
Safety: 1.Solicited post-vaccination reactions Efficacy:1. Laboratory-confirmed cases of severe rotavirus gastroenteritis due to rotavirus 2. Vaccine impact on the number of severe rotavirus gastroenteritis cases per 100 children/yearTimepoint: for 2 Years	—

Countries

India

Contacts

Public ContactDr Sajjad Desai

Serum Institute of India Ltd

drpsk@seruminstitute.com

Outcome results