NCT03462108 is a Phase 1 clinical trial of Rotavirus (Bio Farma) Vaccine in Safety Issues, sponsored by PT Bio Farma.

Who is sponsoring NCT03462108?

NCT03462108 is sponsored by PT Bio Farma.

What drugs are being tested in NCT03462108?

Interventions in NCT03462108: Rotavirus (Bio Farma) Vaccine, Placebo.

What condition does NCT03462108 study?

NCT03462108 studies Safety Issues.

Is NCT03462108 still recruiting?

NCT03462108 is currently completed. Last updated 3 April 2019.

Last reviewed 2019-04-03 · How we verify

NCT03462108

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

Safety and Immunogenicity of Rotavirus (Bio Farma) Vaccine in Adults, Children & Neonates

Completed Phase 1 Last updated 3 April 2019

What this trial tests

Phase 1 trial testing Rotavirus (Bio Farma) Vaccine in Safety Issues in 100 participants. Completed in 30 March 2019.

Timeline

9 April 2018

Primary endpoint
18 February 2019

30 March 2019

Quick facts

Lead sponsor	PT Bio Farma
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	100
Start date	9 April 2018
Primary completion	18 February 2019
Estimated completion	30 March 2019
Sites	4 locations across Indonesia

Drugs / interventions tested

Rotavirus (Bio Farma) Vaccine — full drug profile →
Placebo

Conditions studied

Safety Issues — all drugs for Safety Issues →

Sponsor

PT Bio Farma — full company profile →

Who can join

Adults 1 Minute to 40, any sex, with Safety Issues. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is to assess the safety of Rotavirus (Bio Farma) vaccine in adults, children and neonates.

Publications & conference data

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

Vaccines for preventing rotavirus diarrhoea: vaccines in use.
Soares-Weiser K, Bergman H, Henschke N, Pitan F, et al · · 2019 · cited 40× · PMID 31684685 · DOI 10.1002/14651858.cd008521.pub5
Vaccines for preventing rotavirus diarrhoea: vaccines in use.
Soares-Weiser K, Bergman H, Henschke N, Pitan F, et al · · 2019 · cited 40× · PMID 30912133 · DOI 10.1002/14651858.cd008521.pub4

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 NCT03462108 (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: 3 April 2019

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/NCT03462108.

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