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A Real World Evaluation of safety, immunogenicity and efficacy of COVID-19 Vaccines among health care workers

A real world study to evaluate the safety, immunogenicity and efficacy of COVID 19 vaccines during the national vaccination roll out among health care workers in a tertiary care hospital

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2021/01/030582
Enrollment
5000
Registered
2021-01-19
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Nil: Nil

Sponsors

Medanta Institute of Education and Research
Lead Sponsor

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

MeasureTime 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

MeasureTime frame
To assess humoral immunogenicity (Time Frame: 180 days)Timepoint: 06 months

Countries

India

Contacts

Public ContactDr Pooja Sharma

Medanta The Medicity

vikasdeswal1986@gmail.com0124-4141414

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 12, 2026