NCT05067894

Safety and Immunogenicity of SARS-CoV-2 Protein Subunit Recombinant Vaccine

A Phase I, Observer-Blind, Randomized, Controlled Study of the Safety and Immunogenicity of SARS-CoV-2 Protein Subunit Recombinant Vaccine in Healthy Populations Aged 18 Years and Above in Indonesia

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: PT Bio Farma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

This trial is observer blinded, comparative, randomized, phase I study. Approximately 60 subjects will be recruited (18 years and above). The investigational product is 0.5 ml in three dose-regimen (for all subjects) with 28 days apart between doses, compare to an active control (inactivated SARS-CoV-2 vaccine)

Conditions

• Covid19

Interventions

Type	Name	Description
BIOLOGICAL	SARS-CoV-2 Protein Subunit Recombinant Vaccine	intramuscular injection
BIOLOGICAL	SARS-CoV-2 Inactivated Vaccine	intramuscular injection

Timeline

• Start date: 2021-12-10
• Primary completion: 2022-04-11
• Completion: 2022-08-06
• First posted: 2021-10-05
• Last updated: 2022-08-09

Locations

1 site across 1 country: Indonesia