Study to check the effect of Covovax vaccine when administered as booster dose in adults in India who have already received two doses of COVID-19 vaccines
- Registration Number
- CTRI/2022/04/042017
- Lead Sponsor
- Serum Institute of India Private Limited Pune
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 372
1. Adults aged more than or equal to 18 years of either sex
2. Written informed consent by participants
3. Those who have completed primary COVID-19 vaccination schedule with at least 6 months ago
4. Female participants of childbearing potential must have a negative urine pregnancy test within 24 hours prior to study vaccine administration
1. Acute illness at the time of screening
2. History of laboratory confirmed COVID-19
3. History of allergic reactions after previous vaccinations including primary vaccination for COVID-19
4. Have any bleeding disorder which is considered as a contraindication to intramuscular injection or blood draw
5. Suspected or known current alcohol or drug dependence
6. Chronic administration of immunosuppressant or other immune-modifying drugs within three months prior to the study vaccination or planned use throughout the study period
7. Administration of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the past 3 months or planned use throughout the study period
8. Administration of any vaccine within 28 days prior to enrolment in the study or planned administration of any vaccine for until 28 days after study vaccination
9. Prior receipt of a booster dose of COVID-19 vaccine
10. Pregnant or breast-feeding
11. Acute or chronic, clinically significant systemic disorders
12. Any other condition that in the opinion of the investigator would jeopardize the safety or rights of the participant in the study or make it unlikely that the participant could complete the protocol
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Anti-S IgG and Neutralizing antibodiesTimepoint: 28 days after vaccination
- Secondary Outcome Measures
Name Time Method Anti-S IgG and Neutralizing antibodiesTimepoint: at Day 91 and Day 181;Occurrence of SAEs, and adverse events of special interest (AESI) throughout the study duration following vaccinationTimepoint: 180 Days Post Vaccination;Occurrence of solicited local and systemic adverse events (AEs) for 7 days post-vaccinationTimepoint: 7 days post-vaccination;Occurrence of unsolicited AEs for 28 days post-vaccinationTimepoint: 28 days post-vaccination