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Booster Study of COVID-19 Protein Subunit Recombinant Vaccine

NCT05525208 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 696

Last updated 2025-06-03

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

SARS-CoV-2 subunit protein recombinant vaccine

SARS-CoV-2 RBD subunit recombinant protein, manufactured by PT. Bio Farma

BIOLOGICAL

Active Comparator

The Pfizer-BioNTech® COVID-19 vaccine or BNT162b2, is an mRNA vaccine encoding a P2 mutant spike protein (PS 2) and formulated as an RNA-lipid nanoparticle of nucleoside-modified mRNA (modRNA).

Sponsors & Collaborators

  • Universitas Padjadjaran

    collaborator OTHER

  • Udayana University

    collaborator OTHER

  • PT Bio Farma

    lead INDUSTRY

Principal Investigators

  • Kusnandi Rusmil, Prof, MD · Faculty of Medicine Universitas Padjadjaran

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-09-01
Primary Completion
2023-07-02
Completion
2023-08-04

Countries

  • Indonesia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05525208 on ClinicalTrials.gov