Who is sponsoring NCT00489099?

NCT00489099 is sponsored by Merck Sharp & Dohme LLC.

What drugs are being tested in NCT00489099?

Interventions in NCT00489099: V232 Modified Process Hepatitis B Vaccine: Lot A, V232 Modified Process Hepatitis B Vaccine: Lot B, V232 Modified Process Hepatitis B Vaccine: Lot C, V232 Current Process Hepatitis B Vaccine.

What condition does NCT00489099 study?

NCT00489099 studies Hepatitis B Infection.

Is NCT00489099 still recruiting?

NCT00489099 is currently completed. Last updated 15 March 2017.

Last reviewed 2017-03-15 · How we verify

NCT00489099

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

A Study in Healthy Young Adults To Assess the Safety, Tolerability, and Immunogenicity of a Recombinant Hepatitis B Vaccine Manufactured by a Process Upgrade

Completed Phase 3 Last updated 15 March 2017

What this trial tests

Phase 3 trial testing V232 Modified Process Hepatitis B Vaccine: Lot A in Hepatitis B Infection in 860 participants. Completed in 1 May 2006.

Timeline

1 June 2005

Primary endpoint
1 May 2006

1 May 2006

Quick facts

Lead sponsor	Merck Sharp & Dohme LLC
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	860
Start date	1 June 2005
Primary completion	1 May 2006
Estimated completion	1 May 2006

Drugs / interventions tested

V232 Modified Process Hepatitis B Vaccine: Lot A — full drug profile →
V232 Modified Process Hepatitis B Vaccine: Lot B — full drug profile →
V232 Modified Process Hepatitis B Vaccine: Lot C — full drug profile →
V232 Current Process Hepatitis B Vaccine — full drug profile →

Conditions studied

Hepatitis B Infection — all drugs for Hepatitis B Infection →

Sponsor

Merck Sharp & Dohme LLC — full company profile →

Who can join

Adults 20 to 35, any sex, with Hepatitis B Infection. Healthy volunteers can join.

What's being measured

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

Number of Participants with Seroprotection to Hepatitis B Surface Antigen
Time frame: 1 month after the third vaccination (Month 7)
Geometric Mean Titers to Hepatitis B Surface Antigen
Time frame: 1 month after the third vaccination (Month 7)

Sponsor's own description

A study to evaluate the safety, tolerability, and immunogenicity of a recombinant hepatitis B vaccine manufactured using an upgrade to the production process. The primary hypotheses tested at 1 month after the third dose of vaccine are the following: 1) the 3 lots of the process upgrade vaccine induce similar seroprotection rates to hepatitis B surface antigen (HBsAg), 2) the combined lots of the process upgrade vaccine induce adequate seroprotection to HBsAg, and 3) the process upgrade vaccine will induce geometric mean antibody titers to HBsAg that are non-inferior or superior to those induced by the current process vaccine.

Publications & conference data

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

Corrigendum.
· 2017 · PMID 28409707 · DOI 10.1080/21645515.2017.1314658

Verify or expand the search:

Other recruiting trials for Hepatitis B Infection

Currently open trials in the same condition.

NCT04704024 — Reducing Vertical Transmission of Hepatitis B in Africa · Phase 3 · active not recruiting
NCT05117541 — Social-environmental, Psychosocial, Behavioral, Clinical and Biological Drivers of Disparities in Liver Disease Progress · active not recruiting

Other Merck Sharp & Dohme LLC trials

Trials by the same sponsor.

NCT07224477 — A Clinical Study of V540A in Healthy Female Participants (V540A-005) · Phase 2 · not yet recruiting
NCT07302347 — A Study of Pembrolizumab in Japanese Pediatric Participants With Solid Tumors or Lymphomas and Japanese Adult Participan · Phase 1, PHASE2 · recruiting
NCT07528508 — A Clinical Trial in Healthy Participants to Study the Effect of a Single Dose of MK-8527 on Levels of Methadone (MK-8527 · Phase 1 · not yet recruiting
NCT07513376 — A Clinical Trial of Adjuvant Intismeran (V940) With or Without Pembrolizumab Coformulated With Berahyaluronidase Alfa (M · Phase 3 · not yet recruiting
NCT07532304 — A Clinical Trial of MK-4646 With Bictegravir/Emtricitabine/Tenofovir Alafenamide and Dolutegravir in Healthy Adult Parti · Phase 1 · not yet 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 NCT00489099 (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 Merck Sharp & Dohme LLC
Last refreshed: 15 March 2017

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/NCT00489099.

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