Ignite Creation Date:
2025-12-25 @ 2:39 AM
Ignite Modification Date:
2025-12-28 @ 1:29 AM
Study NCT ID:
NCT01353534
Status:
COMPLETED
Last Update Posted:
2012-10-18
First Post:
2011-05-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Open-label Study to Assess Immunogenicity and Safety of a Vaccine Enhancement Patch When Administered With 2 Doses of H5N1 Vaccine
Sponsor:
Intercell USA, Inc.
Organization:
Study Overview
Official Title:
A Phase 1/2, Randomized, Open-Label, Study to Assess the Immunogenicity and Safety of a Vaccine Enhancement Patch (VEP) When Administered With Two Doses of Intramuscular Inactivated Influenza H5N1 Vaccine in Healthy Adults
Status:
COMPLETED
Status Verified Date:
2012-10
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:
Groups 1 to 3 will receive two vaccinations on Day 0 and Day 21. Group 1 will receive 3.8µg A/H5N1 antigen formulated with AS03 adjuvant, administered by IM injection. Group 2 will receive 15µg A/H5N1 by IM alone. Group 3 will also receive 15µg A/H5N1 antigen administered IM but followed by the topical application of a VEP at the vaccination site. Group 4 will receive a single vaccination on Day 0 of 30µg A/H5N1antigen by IM, followed by application of a VEP at the vaccination site.
The VEP (Vaccine Enhancement Patch) contains 50 mcg LT (heat-labile enterotoxin of E. coli)
The VEP (Vaccine Enhancement Patch) contains 50 mcg LT (heat-labile enterotoxin of E. coli)
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?: