Study to check the safety and immune response of a COVID-19 vaccine in healthy Indian adults.

Phase 2

Completed

• Registration Number: CTRI/2020/08/027170
• Lead Sponsor: Serum Institute of India Private Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-06-02
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 1600

Inclusion Criteria

1. Healthy adults aged more than or equal to 18 years of either sex.

2. Written informed consent by participants.

3. The participant is resident of the study area and is willing to comply with study protocol requirements.

4. Healthy, as determined by medical history and physical examination.

5. Female participants of childbearing potential must have a negative urine pregnancy test within 24 hours prior to study vaccine administration.

Exclusion Criteria

1. Acute illness with or without fever at the time of study vaccine administration

2. History of laboratory confirmed COVID-19 disease in household contact or close workplace contact

3. IgG seropositivity to SARS-CoV-2

4. History or currently positive for SARS-CoV-2 by RT-PCR

5. History of severe allergic reactions after previous vaccinations or hypersensitivity to any component of study vaccines

6. Any confirmed or suspected condition with impaired/altered function of immune system

Study & Design

• Study Type: Interventional
• Study Design: Not specified