To determine the safety and antibody performance in Indian adults after taking COVID-19 vaccine.
Not Applicable
- Registration Number
- CTRI/2021/03/031998
- Lead Sponsor
- Advanced Cancer for Treatment Research and Education in cancer and Tata Memorial Centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1) Adults >= 18 years.
2) TMC staff who received at least one dose of the ChAdOx1 nCoV-19 vaccine at the KEM vaccination centre.
3) All individuals who got vaccinated at ACTREC vaccination centre.
Exclusion Criteria
None.
Anyone fulfilling the inclusion criteria will be eligible for the study
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate safety for the vaccine in participants receiving at least 1 dose of the vaccine.Timepoint: 1) Local reactions for up to 7 days following each dose. <br/ ><br> <br/ ><br>2)Systemic events for up to 7 days following each dose. <br/ ><br> <br/ ><br>3) Adverse events (AEs) from Dose 1 to 1 month after the last dose. <br/ ><br> <br/ ><br>4) Serious AEs (SAEs) from Dose 1 to 6 months after the last dose.
- Secondary Outcome Measures
Name Time Method SARS-CoV-2 IgG levels will be measured at prespecified time <br/ ><br>points.Timepoint: On days 7,14,28,56,90 and 120 the IgG levels will be measured.