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A study determine effectiveness and safety of COVID-19 vaccination in health care workers in India

A cross sectional real world evidence (RWE) study of effectiveness and safety of COVID-19 vaccination in health care workers in India

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2021/08/036013
Enrollment
2000
Registered
2021-08-27
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

None listed

Sponsors

Indian Society of Clinical Research
Lead Sponsor
Apollo Research and Innovations
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: health care workers who have received at least 1 dose of Covishiled or Covaxin between 16 Dec 2020 and 30 Apr 2021

Exclusion criteria

Exclusion criteria: health care workers who did not take any COVID-19 vaccine

Design outcomes

Primary

MeasureTime frame
1) Post vaccination infection with COVID-19 (as confirmed by RT PCR and antigen test results) and duration between the last dose and infection and how many doses of vaccines were taken 2) Number and percentage of Adverse events following Immunization (AEFI) will be presented such as: pain at injection site, body ache, fever, hospitalization and reason for hospitalization etcTimepoint: At the time of study data collection

Secondary

MeasureTime frame
1) Association between post vaccination clinical symptoms (as mention in primary end point) and other variables such as a. Age (18-30 years, 31-44 years, 45-59 years and more then 60 years) b. Gender (male, female) c. Name of vaccine (covishield, covaxin) d. Dose of the vaccine (first or second dose) e. Duration between the two doses (how many weeks between the two doses) f. Name of COVID-19 vaccine g. Time from vaccination to symptoms h. Medical and para-medical workers 2) Results of post vaccination antibody Test will be describe if availableTimepoint: At the time of study data collection

Countries

India

Contacts

Public ContactMs Jayanthi Swaminathan

Apollo Research and Innovations

jayanthi.s@apolloari.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026