Trials / Completed
CompletedNCT00489099
A Research Study to Test Safety, Tolerability, and Immunogenicity of a Recombinant Hepatitis B Vaccine Manufactured With an Upgrade to the Production Process (V232-054)
A Study in Healthy Young Adults To Assess the Safety, Tolerability, and Immunogenicity of a Recombinant Hepatitis B Vaccine Manufactured by a Process Upgrade
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 860 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 20 Years – 35 Years
- Healthy volunteers
- Accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | V232 Modified Process Hepatitis B Vaccine: Lot A | |
| BIOLOGICAL | V232 Modified Process Hepatitis B Vaccine: Lot B | |
| BIOLOGICAL | V232 Modified Process Hepatitis B Vaccine: Lot C | |
| BIOLOGICAL | V232 Current Process Hepatitis B Vaccine |
Timeline
- Start date
- 2005-06-01
- Primary completion
- 2006-05-01
- Completion
- 2006-05-01
- First posted
- 2007-06-21
- Last updated
- 2017-03-16
Source: ClinicalTrials.gov record NCT00489099. Inclusion in this directory is not an endorsement.