NCT05541289

Expanded Access Program of Whole, Inactivated COVID-19 Vaccine COVAXIN™ (BBV152) in Adults Aged 18 Years and Older

An Intermediate Size Expanded Access Program of Whole, Inactivated SARS-CoV-2 Vaccine COVAXIN™ (BBV152) in Adults Aged 18 Years and Older

• Status: No Longer Available
• Phase: —
• Study type: Expanded Access
• Enrollment: —
• Sponsor: Ocugen · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: —

Summary

This Expanded Access, Phase 3, open label study is intended to provide access to COVAXIN™ (BBV152) to individuals who are at risk or have predisposing conditions that can lead to complications with the current immunization options against SAR-CoV-2 Virus infection.

Detailed description

This is an open-label single-arm single-center protocol designed to provide expanded access and evaluate the safety of COVID-19 Vaccine, COVAXIN™ (BBV152) in adults, who either decline or do not qualify for current m-RNA based Covid19 vaccines and whose locations or circumstances put them at appreciable risk of exposure to SARS-CoV-2 and development of COVID-19. Each participant will receive a 2-dose regimen of the study vaccine (SV) as an intramuscular (IM) injection in the deltoid region of the upper arm at least 28 days apart (the first dose on Day 1 and the second dose on Day 29). Safety assessment will include monitoring: Adverse events following immunization (AEFI) ; Adverse event of special interest (AESI) defined for COVID-19 vaccines; Serious adverse event following immunization (SAEFI) ; Medically Attended Adverse Events (MAAE); Potentially Immune Mediated Medical Conditions (PIMMC).

Conditions

• COVID-19

Interventions

Type	Name	Description
BIOLOGICAL	BBV152	Single Arm; BBV152 (COVAXIN™)

Timeline

• First posted: 2022-09-15
• Last updated: 2022-09-22

Locations

1 site across 1 country: United States