NCT02152709 is a Phase 3 clinical trial of 3 dose of 10µg/0.5ml hepatitis B vaccine in Hepatitis B, sponsored by Jiangsu Province Centers for Disease Control and Prevention.

Who is sponsoring NCT02152709?

NCT02152709 is sponsored by Jiangsu Province Centers for Disease Control and Prevention.

What drugs are being tested in NCT02152709?

Interventions in NCT02152709: 3 dose of 10µg/0.5ml hepatitis B vaccine, 3 dose of 5µg/0.5ml hepatitis B vaccine.

What condition does NCT02152709 study?

NCT02152709 studies Hepatitis B.

Is NCT02152709 still recruiting?

NCT02152709 is currently completed. Last updated 28 May 2014.

Last reviewed 2014-05-28 · How we verify

NCT02152709

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

A Phase 3, Randomized, Controlled, and Blinded Clinical Trial to Evaluate Safety and Immunogenicity of 10µg/0.5ml Hepatitis B Vaccine for Infants and Other Age Groups.

Completed Phase 3 Last updated 28 May 2014

What this trial tests

Phase 3 trial testing 3 dose of 10µg/0.5ml hepatitis B vaccine in Hepatitis B in 1,537 participants. Completed in 1 October 2010.

Timeline

1 November 2008

Primary endpoint
1 March 2010

1 October 2010

Quick facts

Lead sponsor	Jiangsu Province Centers for Disease Control and Prevention
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	1,537
Start date	1 November 2008
Primary completion	1 March 2010
Estimated completion	1 October 2010
Sites	1 location across China

Drugs / interventions tested

3 dose of 10µg/0.5ml hepatitis B vaccine — full drug profile →
3 dose of 5µg/0.5ml hepatitis B vaccine — full drug profile →

Conditions studied

Hepatitis B — all drugs for Hepatitis B →

Sponsor

Jiangsu Province Centers for Disease Control and Prevention — full company profile →

Who can join

Adults 1 Day to 75, any sex, with Hepatitis B. Healthy volunteers can join.

What's being measured

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

Number of subjects with adverse events
Time frame: Within 28 days after hepatitis B vaccination
To analyze the number of subjects with adverse events within 28 days after administered each of hepatitis B vaccine.
Geometric mean concentration of anti-hepatitis B virus surface antigen antibody
Time frame: The 28th day after whole course of hepatitis B vaccination
Geometric mean concentration of anti-hepatitis B virus surface antigen antibody was measured by chemiluminescence assay and expressed with mIU/mL.

Sponsor's own description

The main objective of this study was to evaluate the safety and immunogenicity of 10µg/0.5ml and 5µg/0.5ml hepatitis B vaccine made by recombinant deoxyribonudeic acid techniques in saccharomyces cereviside yeast for infants and other age groups.

Publications & conference data

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

Efficacy of antigen dosage on the hepatitis B vaccine response in infants born to hepatitis B-uninfected and hepatitis B-infected mothers.
Kang G, Ma F, Chen H, Yang Y, et al · · 2015 · cited 8× · PMID 26144895 · DOI 10.1016/j.vaccine.2015.06.081
Comparison of the effect of increased hepatitis B vaccine dosage on immunogenicity in healthy children and adults.
Kang G, Chen H, Ma F, Yang Y, et al · · 2016 · cited 7× · PMID 27215279 · DOI 10.1080/21645515.2016.1172757

Verify or expand the search:

Other recruiting trials for Hepatitis B

Currently open trials in the same condition.

NCT04843852 — TLR-9 Adjuvanted Vaccination for Chronic Hepatitis B · Phase 1 · recruiting
NCT07168356 — A Study to Evaluate Blood Levels of Bepirovirsen in Adult Participants With Severe or Moderate Kidney Disease · Phase 1 · recruiting
NCT06947356 — Comparison of TAF and TDF in Preventing Mother-to-Child Transmission of HBV in Pregnancies With High Viral Loads · NA · recruiting
NCT06537414 — A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living Wit · Phase 2 · active not recruiting
NCT06623071 — Accupower ® HBV Performance Evaluation Quant Kit Bioneer Existation FA 96/384 · recruiting

Other Jiangsu Province Centers for Disease Control and Prevention trials

Trials by the same sponsor.

NCT07530679 — Study on the Safety, Humoral Immune Response, and Memory B Cell Response Characteristics of Sequential 9-Valent HPV Vacc · NA · not yet recruiting
NCT07232745 — Mucosal and Systemic Immune Responses Induced by an Intranasal Influenza Live Attenuated Vaccine · Phase 4 · active not recruiting
NCT06609811 — The Interaction Between Mucosal Microbiota Colonization and the Immune Response to an Intranasal Influenza Live Attenuat · Phase 4 · completed
NCT07035054 — Phase Ⅱ Clinical Trial of 24-valent Pneumococcal Polysaccharide Conjugate Vaccine · Phase 2 · completed
NCT07025876 — PhaseⅠClinical Trial of 24-valent Pneumococcal Polysaccharide Conjugate Vaccine · EARLY_PHASE1 · 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 NCT02152709 (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 Jiangsu Province Centers for Disease Control and Prevention
Last refreshed: 28 May 2014

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/NCT02152709.

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