Evaluation of Full Versus Fractional Dose of COVID-19 Vaccine Given as a Booster for the Preventi… (NCT05265065) | Clinical Trial Compass
CompletedPhase 3
Evaluation of Full Versus Fractional Dose of COVID-19 Vaccine Given as a Booster for the Prevention of COVID-19 in Adults in Mongolia.
Mongolia601 participantsStarted 2022-05-27
Plain-language 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 booster dose in adults, who have previously received either Sinopharm (BBIBP-CorV®), AstraZeneca (ChAdOx1-S, or Vaxzevria®) or Sputnik V (Gam-COVID-Vac®) as their primary doses 6 to 9 months earlier. Both standard and fractional doses will be tested.
Participants are healthy adults aged 18 years or older, with no upper age limit. Procedures will be implemented to ensure participants of all ages (aged 18 and above) are included and that there is an even age distribution (\<50 and ≥50 years) in each group. There will be a total of 6 groups (Sinopharm-standard dose Pfizer, Sinopharm-fractional dose Pfizer, AstraZeneca-standard dose Pfizer, AstraZeneca-fractional dose Pfizer, Sputnik - standard dose Pfizer, Sputnik - fractional dose Pfizer), with 200 participants per group for Sinopharm and 100 for AstraZeneca and Sputnik.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
âś“. Have completed two doses of Sinopharm, AstraZeneca or Sputnik vaccines with the recommended schedule 6 months prior to the date of enrolment
âś“. Willing and able to give written informed consent
âś“. Aged 18 years or above
âś“. Willing to complete the follow-up requirements of the study
Exclusion criteria
âś•. Received 3 doses of COVID-19 vaccine
âś•. Received 2 doses of COVID-19 less than 6 months prior to the start of the trial
âś•. Currently on immunosuppressive medication or anti-cancer chemotherapy
âś•. HIV infection
âś•. Congenital immune deficiency syndrome
âś•. Has received immunoglobulin or other blood products in the 3 months prior to vaccination