Ignite Creation Date:
2024-05-05 @ 4:46 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00311675
Status:
COMPLETED
Last Update Posted:
2010-08-27
First Post:
2006-04-05
Brief Title:
St Jude Open Label H5 Trial
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Single Center Open-Label Phase III Study of Two 90-µg Doses of Intramuscular Inactivated Influenza AH5N1 Vaccine in Healthy Adult Subjects
Status:
COMPLETED
Status Verified Date:
2008-07
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 see how antibodies proteins that fight infection are made after you receive the new H5N1 flu vaccine The new H5N1 vaccine will be given to 50 healthy adult lab workers aged 18 years and older Subjects will receive two 90mcg injections shots in the arm of the vaccine about 1 month apart Subjects will maintain a memory aid to record oral temperature and any response to the vaccine for 7 days after each immunization Subjects will be contacted by telephone 1 to 3 days after vaccination They will return to the clinic on Day 7 Blood will be drawn before each vaccination and on Days 56 and 180 Subjects may be involved in the study for about 6 months It is anticipated that the vaccine will provide safe protection against influenza H5N1
Detailed Description:
The purpose of this open-label phase III study is to investigate the safety and immunogenicity of two 90-mcg doses of intramuscular inactivated influenza AH5N1 vaccine in healthy adults aged 18 years and older Subjects will receive 2 doses of the vaccine separated by approximately 28 days Subjects will maintain a memory aid to record oral temperature and systemic and local adverse events AEs for 7 days after each immunization Subjects will be contacted by telephone 1 to 3 days after vaccination approximately Day 2 to assess concomitant medications and the occurrence of AEs and they will return to the clinic on Day 7 for AE and concomitant medication assessment a targeted physical examination if indicated and review of the memory aid Serum for immunogenicity evaluations will be obtained prior to the first vaccination Day 0 and prior to the second vaccination at Day 28 and on Days 56 and 180 Primary objectives are to determine the safety of subvirion inactivated AH5N1 vaccine in healthy adults and to determine the immunogenicity of subvirion inactivated H5N1 vaccine in healthy adults approximately 1 month following receipt of each of two 90 mcg doses of vaccine The secondary objective is to evaluate immunogenicity and the percent of subjects responding approximately 1 and 7 months after the first vaccination Primary endpoints are AE or serious adverse event information solicited in-clinic and via memory aids concomitant medications and periodic targeted physical assessment geometric mean titer GMT and frequency of 4-fold or greater increases in neutralizing antibody titers 28 days after receipt of second dose of the vaccine and GMT and frequency of 4-fold or greater increases in serum hemagglutination inhibition HAI antibody titers against the influenza AH5N1 virus 28 days after receipt of the second dose of the vaccine The secondary endpoints are GMT and frequency of 4-fold or greater increases in neutralizing antibody titers in each group 1 month and 7 months after receipt of the first dose of vaccine GMT and frequency of 4-fold or greater increases in serum hemagglutination inhibition HAI antibody titers in each group 1 month and 7 months after receipt of the first dose of vaccine and development of serum antibody responses against antigenically drifted variants of H5N1 influenza viruses
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