Ignite Creation Date:
2024-05-05 @ 4:50 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00322361
Status:
COMPLETED
Last Update Posted:
2017-03-16
First Post:
2006-05-02
Brief Title:
Modified Process Hepatitis B Vaccine in Healthy Neonates V232-056
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
A Study in Healthy Neonates of Safety Tolerability and Immunogenicity of Recombinant Hepatitis B Vaccine Manufactured Using a Modified Process
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:
Hepatitis B Vaccine Recombinant is a well-established vaccine which has been used extensively worldwide since its initial licensure in 1986 Hepatitis B vaccines 1 induce protection against the morbidity and mortality of acute hepatitis B virus infection 2 reduce the incidence of chronic infection in vaccinated populations and 3 thereby reduce the incidence of hepatocellular carcinoma The purpose of the trial is to assess if the new manufacturing process of the Hepatitis B Vaccine Recombinant vaccine shows the same level of hepatitis B antibody response or better as the currently licensed Hepatitis B Vaccine Recombinant vaccine This study will also confirm that the new process vaccine is as well tolerated as the current 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 |
|---|---|---|---|
| 2006_007 | None | None | None |