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Clinical Trial Summary

The study is an observer-blind, randomized, controlled prospective intervention study of Phase I/II. The primary objective of Phase I is To evaluate the safety of the SARS-CoV-2 protein subunit recombinant vaccine within 7 days after each dose. Whereas, the primary objective of Phase II is to evaluate the immunogenicity profile of the SARS-CoV-2 protein subunit recombinant vaccine.


Clinical Trial Description

This trial is observer blinded, comparative, randomized, phase I/II study. For phase I, approximately 90 subjects will be recruited and will seamlessly continue to phase II recruiting 690 subjects, in total 780 subjects (18 years and above). Two different formulations of vaccine candidate (SARS-CoV-2 protein subunit recombinant vaccine) will be compared to active control. The investigational product is 0.5 ml in three dose-regimen (for all subjects) with 28 days apart between doses. Antibody testing after two doses will be conducted to compare the immunogenicity profile between two and three-dose administration. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05067894
Study type Interventional
Source PT Bio Farma
Contact Rini Mulia Sari, MD
Phone +6222-2033755
Email [email protected]
Status Not yet recruiting
Phase Phase 1/Phase 2
Start date October 2021
Completion date March 2022

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