NCT01865968 is a Phase 4 clinical trial of Inactivated HAV vaccine in Hepatitis A, sponsored by Sinovac Biotech Co., Ltd.

Who is sponsoring NCT01865968?

NCT01865968 is sponsored by Sinovac Biotech Co., Ltd.

What drugs are being tested in NCT01865968?

Interventions in NCT01865968: Inactivated HAV vaccine, Live attenuated HAV vaccine.

What condition does NCT01865968 study?

NCT01865968 studies Hepatitis A.

Is NCT01865968 still recruiting?

NCT01865968 is currently completed. Last updated 13 May 2015.

Last reviewed 2015-05-13 · How we verify

NCT01865968

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

Phase IV Trial to Compare the Safety, Immunogenicity,Three-year Immune Persistence of Inactivated Hepatitis A Vaccine (HAV) With One- or Two-dose Regimen and Live Attenuated HAV With One-dose Regimen in Chinese Young Adults, and to Evaluate the Immunogenicity of a Booster Dose.

Completed Phase 4 Last updated 13 May 2015

What this trial tests

Phase 4 trial testing Inactivated HAV vaccine in Hepatitis A in 239 participants. Completed in 1 September 2012.

Timeline

1 October 2008

Primary endpoint
1 December 2011

1 September 2012

Quick facts

Lead sponsor	Sinovac Biotech Co., Ltd
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	239
Start date	1 October 2008
Primary completion	1 December 2011
Estimated completion	1 September 2012
Sites	1 location across China

Drugs / interventions tested

Inactivated HAV vaccine — full drug profile →
Live attenuated HAV vaccine — full drug profile →

Conditions studied

Hepatitis A — all drugs for Hepatitis A →

Sponsor

Sinovac Biotech Co., Ltd — full company profile →

Who can join

Adults 16 to 25, any sex, with Hepatitis A. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

concentration of antibody to hepatitis A virus
Time frame: 37 months
Anti-HAV antibody geometric mean concentrations pre-vaccination, and at month 1, and 12, 24 and 36, and 1 months (month 37) after the booster vaccination.

Sponsor's own description

A phase IV, randomization, single center, controlled clinical trial to compare the safety, immunogenicity,three-year immune persistence of inactivated hepatitis A vaccine (HAV) with one- or two-dose regimen and live attenuated HAV with one-dose regimen in Chinese young adults, and to evaluate the immunogenicity of a booster dose.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Comparison of Immunogenicity Between Inactivated and Live Attenuated Hepatitis A Vaccines Among Young Adults: A 3-Year Follow-up Study.
Liu XE, Chen HY, Liao Z, Zhou Y, et al · · 2015 · cited 8× · PMID 25969561 · DOI 10.1093/infdis/jiv213

Verify or expand the search:

Other recruiting trials for Hepatitis A

Currently open trials in the same condition.

NCT07358910 — Risk Assessment of Community Spread of Multiple Endemic Infectious Diseases in a One Health Perspective · recruiting
NCT06978621 — Immunogenicity and Safety of I-HAV in Healthy Thai Children and Adolescents Lacking Protective Antibody After L-HAV · Phase 3 · recruiting
NCT06058416 — Immunogenicity and Safety of Hepatitis A Among People Aged 18-50 Years Old · Phase 4 · active not recruiting

Other Sinovac Biotech Co., Ltd trials

Trials by the same sponsor.

NCT07418229 — Study to Evaluate the Safety of a Lyophilized RSV mRNA Vaccine · Phase 1 · not yet recruiting
NCT07416110 — Phase IIIb Clinical Trial to Evaluate Lot-to-lot Consistency of Sinovac Rabies Vaccine · Phase 3 · not yet recruiting
NCT07055295 — Immunogenicity and Safety of Rabies Vaccine (Serum-free Vero Cell) in a Pre-exposure Prophylaxis Regimen · Phase 3 · not yet recruiting
NCT07055893 — Immunogenicity and Safety of Rabies Vaccine (Serum-free Vero Cell) in a Simulated Post-exposure Prophylaxis Regimen · Phase 3 · not yet recruiting
NCT07400003 — Study to Evaluate the Safety and Immunogenicity of a Lyophilized Herpes Zoster Virus mRNA Vaccine · Phase 1, PHASE2 · recruiting

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 NCT01865968 (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 Sinovac Biotech Co., Ltd
Last refreshed: 13 May 2015

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/NCT01865968.

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