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Clinical Trial Summary

Observer-blind, randomized, active-controlled prospective intervention study of Immunogenicity & Safety of SARS-Cov-2 Protein Subunit Recombinant Vaccine (Bio Farma) as a Booster Dose Against COVID-19 in Adults 18 Years of Age and Older.


Clinical Trial Description

This trial is observer-blind, randomized, prospective intervention study. In this study 900 subjects who had received complete primary doses of authorized/approved inactivated (Sinovac®), mRNA (Pfizer®), or viral vector (AstraZeneca®) COVID-19 vaccine and willing to participate in the booster study by signing the consent form, will be involved in this trial. Subject will be divided into six groups, each 150 subjects per arm who had received a complete primary dose of inactivated (Sinovac®) vaccine, mRNA (Pfizer®) vaccine, or viral vector (AstraZeneca®) vaccine will receive one booster dose of SARS-CoV-2 subunit protein recombinant vaccine or active control. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05525208
Study type Interventional
Source PT Bio Farma
Contact Rini M. Sari, MD
Phone +6222-2033755
Email rini.mulia@biofarma.co.id
Status Recruiting
Phase Phase 2
Start date September 1, 2022
Completion date March 30, 2023

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