NCT03460405 is a Phase 2 clinical trial of Vi-DT Vaccine in Safety Issues, sponsored by PT Bio Farma.

Who is sponsoring NCT03460405?

NCT03460405 is sponsored by PT Bio Farma.

What drugs are being tested in NCT03460405?

Interventions in NCT03460405: Vi-DT Vaccine, Vi Polysaccharide Vaccine, IPV Vaccine.

What condition does NCT03460405 study?

NCT03460405 studies Safety Issues, Immunogenicity.

Is NCT03460405 still recruiting?

NCT03460405 is currently completed. Last updated 20 February 2020.

Last reviewed 2020-02-20 · How we verify

NCT03460405

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

Safety and Immunogenicity of Vi-DT Typhoid Conjugate Vaccine in Indonesian Adults, Adolescents, Children and Infants

Completed Phase 2 Last updated 20 February 2020

What this trial tests

Phase 2 trial testing Vi-DT Vaccine in Safety Issues in 600 participants. Completed in 30 January 2020.

Timeline

16 July 2018

Primary endpoint
31 December 2019

30 January 2020

Quick facts

Lead sponsor	PT Bio Farma
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	600
Start date	16 July 2018
Primary completion	31 December 2019
Estimated completion	30 January 2020
Sites	2 locations across Indonesia

Drugs / interventions tested

Vi-DT Vaccine — full drug profile →
Vi Polysaccharide Vaccine — full drug profile →
IPV Vaccine — full drug profile →

Conditions studied

Safety Issues — all drugs for Safety Issues →
Immunogenicity — all drugs for Immunogenicity →

Sponsor

PT Bio Farma — full company profile →

Who can join

Adults 6 Months to 40, any sex, with Safety Issues or Immunogenicity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is to assess the safety and immunogenicity of Vi-DT vaccine in adults, adolescent, children and infants.

Publications & conference data

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

A novel Vi-diphtheria toxoid typhoid conjugate vaccine is safe and can induce immunogenicity in healthy Indonesian children 2-11 years: a phase II preliminary report.
Medise BE, Soedjatmiko S, Gunardi H, Sekartini R, et al · · 2020 · cited 10× · PMID 33059607 · DOI 10.1186/s12887-020-02375-4
One-month follow up of a randomized clinical trial-phase II study in 6 to <24 months old Indonesian subjects: Safety and immunogenicity of Vi-DT Typhoid Conjugate Vaccine.
Medise BE, Soedjatmiko S, Gunardi H, Sekartini R, et al · · 2020 · cited 9× · PMID 32004693 · DOI 10.1016/j.ijid.2020.01.045
A phase II clinical trial of a Vi-DT typhoid conjugate vaccine in healthy Indonesian adolescents and adults: one-month evaluation of safety and immunogenicity.
Koesnoe S, Medise BE, Rengganis I, Hadinegoro SR, et al · · 2024 · cited 4× · PMID 38297337 · DOI 10.1186/s40794-023-00210-z

Verify or expand the search:

Other recruiting trials for Safety Issues

Currently open trials in the same condition.

NCT06485141 — BeSMART Secure Storage Counseling in the Inpatient Setting · NA · recruiting
NCT06494527 — A Phase 1 Study to Evaluate the Safety/Tolerability, PK/PD of RG002C0106 Injection in Healthy Adults · Phase 1 · active not recruiting
NCT06189170 — Phase I Study to Evaluate KP405 in Healthy and Parkinson's Disease Patients · EARLY_PHASE1 · recruiting
NCT06509490 — NKG2D CAR-T(KD-025) in the Treatment of Advanced NKG2DL+ Solid Tumors · NA · recruiting
NCT06498167 — Active Pharmacovigilance Study of the Medicine Rinvoq™ (Upadacitinib) · 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 NCT03460405 (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: 20 February 2020

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/NCT03460405.

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