NCT05433285

Immuno-bridging Study of COVID-19 Protein Subunit Recombinant Vaccine

Immunogenicity & Safety of SARS-CoV-2 Protein Subunit Recombinant Vaccine (Bio Farma) Adjuvanted With Alum+CpG 1018 Compared to Registered Covid-19 Vaccine (Covovax - Protein Subunit Vaccine) in Healthy Populations Aged 18 Years and Above in Indonesia (Phase III)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 4,050 (actual)
• Sponsor: PT Bio Farma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Observer-blind, randomized, active-controlled prospective intervention study

Detailed description

This trial is randomized, prospective intervention study. A total of 4,050 subjects (COVID-19 vaccine naive) who are willing to participate in the study by signing the consent form, will be involved in this trial. The subjects will be divided into three study subsets, namely Main Study I, Main Study II, and Exploratory Study: Main Study I for immunogenicity and safety evaluation, Main Study II for safety evaluation, and Exploratory Study for cellular immunity evaluation, with trial design as follow : * Main Study I, Exploratory Study subset: Observer-blind, randomized, active-controlled prospective intervention study * Main Study II: Open-label, randomized study to evaluate safety I

Conditions

• COVID-19

Interventions

Type	Name	Description
BIOLOGICAL	COVID-19 Protein Subunit Recombinant Vaccine	SARS-CoV-2 RBD subunit recombinant protein, manufactured by PT. Bio Farma
BIOLOGICAL	Active Comparator	Covovax® COVID-19 vaccine is a protein-based vaccine candidate engineered from the genetic sequence of the first strain of the SARS-CoV-2 betacoronavirus

Timeline

• Start date: 2022-06-07
• Primary completion: 2022-08-05
• Completion: 2023-08-31
• First posted: 2022-06-27
• Last updated: 2023-11-29

Locations

4 sites across 1 country: Indonesia