Ignite Creation Date:
2024-05-05 @ 4:38 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00287469
Status:
COMPLETED
Last Update Posted:
2019-05-29
First Post:
2006-02-02
Brief Title:
A Safety and Efficacy Study of the Hepatitis E Vaccine in Nepal
Sponsor:
US Army Medical Research and Development Command
Organization:
US Army Medical Research and Development Command
Study Overview
Official Title:
A Phase II Prospective Randomized Double-blind Placebo Controlled Field Efficacy Trial of a Candidate Hepatitis E Vaccine in Nepal
Status:
COMPLETED
Status Verified Date:
2019-05
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:
The purpose of this study is to determine if a hepatitis E vaccine is safe and able to prevent symptomatic liver disease due to the hepatitis E virus
Detailed Description:
This is a prospective randomized double-blind placebo-controlled with 2 study groups vaccine and placebo Three doses of the study vaccine are given according to a 0 1 6 month schedule Vaccine efficacy will be assessed by maintaining active surveillance for clinical hepatitis every 2 weeks and hospital based surveillance for the full duration of the trial Total planned study population is 2000 eligible subjects 1000 in the vaccine group and 1000 in the placebo group Total vaccinated cohort for the analysis of reactogenicity is 200 100 in the vaccine group and 100 in the placebo group
Volunteers who enroll will be followed for evidence of symptomatic liver disease for approximately 2 years and those who become ill will be admitted to hospital for care
To evaluate safety a randomly designated subset will be monitored for 7 days after each vaccination to solicit specific symptoms at the injection site and generally Additionally all adverse events will be collected for 30 days after each vaccine dose and all serious adverse events will be collected throughout the trial
Volunteers who enroll will be followed for evidence of symptomatic liver disease for approximately 2 years and those who become ill will be admitted to hospital for care
To evaluate safety a randomly designated subset will be monitored for 7 days after each vaccination to solicit specific symptoms at the injection site and generally Additionally all adverse events will be collected for 30 days after each vaccine dose and all serious adverse events will be collected throughout the trial
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| HSRRB A-91171 | None | None | None |
| GSK 304558003 HEV-003 | None | None | None |
| IND 7815 | OTHER | FDA | None |