Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00170443
Status:
COMPLETED
Last Update Posted:
2011-08-12
First Post:
2005-09-09
Brief Title:
Trivalent rHA Dose Escalation Study in Elderly Subjects
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase II Evaluation of the Reactogenicity and Immunogenicity of Different Doses of Intramuscular Trivalent Baculovirus-expressed Influenza HA Vaccine in Healthy Elderly Adults
Status:
COMPLETED
Status Verified Date:
2006-04
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:
This study will compare the safety and immunogenicity of three different dose levels of an experimental recombinant influenza HA protein vaccine to a standard inactivated influenza vaccine in heallthy elderly subjects ages 65-80 Blood and nasal secretions for assessment of antibody responses will be obtained from all subjects prior to and one month after vaccination
Detailed Description:
Approximately 400 healthy ambulatory adults ages 65-80 will be randomized into one of four study groups to receive a single immunization of a licensed trivalent inactivated influenza vaccine or one of three dose levels of an investigatioanl trivalent recombinant influenza HA protein vaccine The study will be conducted in 2 stages In the first stage 80 subjects will be randomized 20 per group and receive one vaccination on Day 0 Safety will be evaluated after Stage 1 subjects have completed a 7 day follow-up Enrollment of Stage 2 subjects will begin after the safety data for Stage 1 has been reviewed In Stage 2 320 subjects will be randomized 80 per group and receive one vaccination on Day 0 Blood and nasal secretions will be collected prior to an approximately one month after vaccination to assess antibody responses
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