None listed
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: All adults above 18 years of age who are working at Medanta The Medicity Gurgaon and are listed in the first COVID 19 vaccination list shared by Medanta HR Team with the GOI Officials will be considered for participation
Exclusion criteria
Exclusion criteria: Participation in COVID-19 prophylactic drug trials before or during the duration study Receipt of any vaccine (licensed or investigational) other than the study intervention within 14 days before and after each study vaccination History of allergic disease or reactions likely to be exacerbated by any component of COVISHIELD Active ongoing laboratory confirmed COVID 19 Administration of immunoglobulins and/or convalescent plasma within the three months preceding the planned administration of the vaccine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the safety of the vaccines by actively reported AE/SAE in the first week of vaccination after each dose of the vaccine (Adverse Event Following Immunization) To assess the safety of the vaccines by passively reported Adverse Vaccine reactions, Vaccine associated Adverse Events of Special Interest (AESI) ,such as Vaccine Associated Enhanced Respiratory Disease (ERD)Timepoint: 06 months | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess humoral immunogenicity (Time Frame: 180 days)Timepoint: 06 months | — |
Countries
India
Contacts
Medanta The Medicity