Status:
COMPLETED
Evaluation of Full Versus Fractional Dose of COVID-19 Vaccine Given as a Booster for the Prevention of COVID-19 in Adults in Mongolia.
Lead Sponsor:
Murdoch Childrens Research Institute
Collaborating Sponsors:
Coalition for Epidemic Preparedness Innovations
The Peter Doherty Institute for Infection and Immunity
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This clinical trial is a single-blind, randomised study to determine the reactogenicity and immunogenicity of severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) vaccine (Pfizer-BioNTech) as ...
Detailed Description
As per brief summary
Eligibility Criteria
Inclusion
- Have completed two doses of Sinopharm, AstraZeneca or Sputnik vaccines with the recommended schedule 6 months prior to the date of enrolment
- Willing and able to give written informed consent
- Aged 18 years or above
- Willing to complete the follow-up requirements of the study
Exclusion
- Received 3 doses of COVID-19 vaccine
- Received 2 doses of COVID-19 less than 6 months prior to the start of the trial
- Currently on immunosuppressive medication or anti-cancer chemotherapy
- HIV infection
- Congenital immune deficiency syndrome
- Has received immunoglobulin or other blood products in the 3 months prior to vaccination
- Study staff and their relatives
- Have a history of a severe allergic reaction to any COVID-19 vaccines or have a medical exception to receiving further COVID-19 vaccines
Key Trial Info
Start Date :
May 27 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 6 2024
Estimated Enrollment :
601 Patients enrolled
Trial Details
Trial ID
NCT05265065
Start Date
May 27 2022
End Date
November 6 2024
Last Update
February 20 2025
Active Locations (1)
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1
District Health Centre
Ulaanbaatar, Mongolia