NCT05433285 is a Phase 3 clinical trial of COVID-19 Protein Subunit Recombinant Vaccine in COVID-19, sponsored by PT Bio Farma.

Who is sponsoring NCT05433285?

NCT05433285 is sponsored by PT Bio Farma.

What drugs are being tested in NCT05433285?

Interventions in NCT05433285: COVID-19 Protein Subunit Recombinant Vaccine, Active Comparator.

Is NCT05433285 still recruiting?

NCT05433285 is currently completed. Last updated 29 November 2023.

Last reviewed 2023-11-29 · How we verify

NCT05433285

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 3 Last updated 29 November 2023

What this trial tests

Phase 3 trial testing COVID-19 Protein Subunit Recombinant Vaccine in COVID-19 in 4,050 participants. Completed in 31 August 2023.

Timeline

7 June 2022

Primary endpoint
5 August 2022

31 August 2023

Quick facts

Lead sponsor	PT Bio Farma
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	4,050
Start date	7 June 2022
Primary completion	5 August 2022
Estimated completion	31 August 2023
Sites	4 locations across Indonesia

Drugs / interventions tested

COVID-19 Protein Subunit Recombinant Vaccine — full drug profile →
Active Comparator — full drug profile →

Conditions studied

COVID-19 — all drugs for COVID-19 →

Sponsor

PT Bio Farma — full company profile →

Who can join

18 and older, any sex, with COVID-19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

Nanotechnology's frontier in combatting infectious and inflammatory diseases: prevention and treatment.
Huang Y, Guo X, Wu Y, Chen X, et al · · 2024 · cited 188× · PMID 38378653 · DOI 10.1038/s41392-024-01745-z
Immunogenicity and safety of SARS-CoV-2 recombinant protein subunit vaccine (IndoVac) adjuvanted with alum and CpG 1018 in Indonesian adults: A phase 3, randomized, active-controlled, multicenter trial.
Nurdin A, Movieta Nency Y, Maddeppungeng M, Sekartini R, et al · · 2024 · cited 6× · PMID 38575433 · DOI 10.1016/j.vaccine.2024.03.077
An assessment of the strategy and status of COVID-19 vaccination in India.
Gupta SL, Goswami S, Anand A, Naman N, et al · · 2023 · cited 5× · PMID 37041424 · DOI 10.1007/s12026-023-09373-5
Immunogenicity Assessment of the SARS-CoV-2 Protein Subunit Recombinant Vaccine (CoV2-IB 0322) in a Substudy of a Phase 3 Trial in Indonesia.
Shakinah S, Aini MH, Sekartini R, Soedjatmiko, et al · · 2024 · cited 1× · PMID 38675753 · DOI 10.3390/vaccines12040371

Verify or expand the search:

Other recruiting trials for COVID-19

Currently open trials in the same condition.

NCT07183709 — Safety and Immunogenicity Trial of PepGNP-COVID19 Vaccine in Adults · Phase 1 · active not recruiting
NCT07300839 — A Study to Learn About a COVID-19 Vaccine in Healthy Adults 50 Through 64 Years of Age · Phase 3 · active not recruiting
NCT07221162 — A Safety and Immunogenicity Trial of Boost-2867 Vaccine, Via Intranasal and Intramuscular Routes · Phase 1 · recruiting
NCT07215520 — Safety and Tolerability of a Newcastle Disease Virus-Based Mucosal COVID-19 Vaccine in Previously Vaccinated Adults · Phase 2 · recruiting
NCT07222384 — A Study to Learn About BNT162b2 (LP.8.1)-Adapted Vaccine Against SARS-CoV-2 in Children 5 Through 11 Years of Age That A · Phase 3 · active not recruiting

Other PT Bio Farma trials

Trials by the same sponsor.

NCT06921460 — Long-Term Protection of Vi Antibodies Induced by Bio TCV in Indonesian Population Compared to PQed TCV · not yet recruiting
NCT06690515 — Phase I/II, Open Label, Randomized, Safety and Immunogenicity Following DTwP-Hepatitis B-Hib-IPV Vaccine (Bio Farma) in · Phase 1, PHASE2 · not yet recruiting
NCT06690502 — Post Authorization Safety Profile of Booster IndoVac COVID-19 Vaccination · completed
NCT05933278 — Homologous Booster Study of COVID-19 Protein Subunit Recombinant Vaccine · Phase 2 · completed
NCT06114641 — Effectiveness & Safety of Ovine Enoxaparin Sodium to Originator Enoxaparin in Non-ST-Segment Elevation ACS Patients · Phase 4 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05433285 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by PT Bio Farma
Last refreshed: 29 November 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05433285.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing