Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2025-12-26 @ 3:50 AM
Study NCT ID:
NCT02015494
Status:
UNKNOWN
Last Update Posted:
2015-03-06
First Post:
2013-12-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase 1 Safety Study of Recombinant Influenza Vaccine for Prevention
Sponsor:
VaxInnate Corporation
Organization:
Study Overview
Official Title:
Phase 1 Study of the Safety and Immunogenicity of VAX2012Q: A Quadrivalent Influenza Vaccine in Healthy Adults Age 18-40 Years
Status:
UNKNOWN
Status Verified Date:
2015-03
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
One dose of escalating strengths of an investigational influenza vaccine VAX2012Q (Quadrivalent Recombinant Hemagglutinin Seasonal Influenza Vaccine) will be evaluated for tolerability and immunogenicity in healthy adults 18-40 years of age.
Detailed Description:
This is a multi-center, open-label, dose escalating study in which up to 320 healthy subjects age 18-40 years will be administered VAX2012Q at one of up to 7 dose levels. VAX2012Q vaccine will be formulated at the clinical site ("field mix") from the four components (VAX128C, VAX181, VAX173 and VAX172) in diluent to produce ten doses in a multi-dose vial for use within 12 hours of preparation. The dose will be prepared from appropriate dilutions from the monovalent drug product vials. Data for safety and immunogenicity will be collected after each dose with safety being assessed after each dose level and immune response, after dose level 4. Reactogenicity and safety labs through Day 1 will be reviewed by the Safety Monitoring Committee (SMC) prior to enrolling in the next dose level.
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| BARDA | OTHER_GRANT | HHSO10020110011C | View |