Ignite Creation Date:
2024-05-05 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00489099
Status:
COMPLETED
Last Update Posted:
2017-03-16
First Post:
2007-06-20
Brief Title:
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
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
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
Status Verified Date:
2017-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2007_565 | None | None | None |