Clinical trial on Rotavirus vaccine to check consistency of different lots of vaccines manufactured and to check vaccine interference with other childhood vaccines given under universal immunization program in India

A phase III, multicenter, open label, randomized study of Bovine Rotavirus Pentavalent Vaccine (BRV-PV) to evaluate lot-to-lot consistency, and to investigate potential interference with routine UIP vaccinations in healthy infants in India.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2015/07/006034

Enrollment

1500

Registered

2015-07-20

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: Pentavalent Rotavirus Vaccine: Live Attenuated human-bovine reassortant pentavalent rotavirus vaccine (BRV-PV) The participants will receive three doses of either of the BRV-PV or com

Eligibility

Inclusion criteria

Inclusion criteria: 1. Healthy infants 2. Age 6-8 weeks 3. Parental willingness to provide written informed consent

Exclusion criteria

Exclusion criteria: 1. Concurrent participation in another clinical trial at any point throughout the entire time frame for this study 2. Presence of malnutrition 3. History of congenital abdominal disorders or abdominal surgery 4. Known or suspected impairment of immunological function 5. A known sensitivity or allergy

Design outcomes

Primary

Measure	Time frame
Rotavirus Immunogenicity Immunogenicity of UIP vaccinesTimepoint: 4 weeks after third dose	—

Secondary

Measure	Time frame
Immediate adverse eventsTimepoint: 30 minutes post-vaccination	—

Countries

India

Contacts

Public ContactDr Sajjad Desai

Serum Institute of India Pvt. Ltd.

drpsk@seruminstitute.com020-26602384

Outcome results