Status:
COMPLETED
Comparative Safety and Immunogenicity of 1.0 µg Intramuscular (i.m.) and 2.0 µg Subcutaneous (s.c.) Dosing With VAX102 (M2e-flagellin) Universal Influenza Vaccine in Healthy Adults
Lead Sponsor:
VaxInnate Corporation
Conditions:
Influenza
Eligibility:
All Genders
18-49 years
Phase:
PHASE1
PHASE2
Brief Summary
1. To assess the safety, reactogenicity, tolerability, and adverse events (AEs) of the VAX102 vaccine in a two dose regimen (Day 0 and Day 28) at the 1.0 µg dose level delivered i.m., or the 2.0 µg do...
Eligibility Criteria
Inclusion
- Adult men or women aged 18 to 49 years inclusive.
- Able and willing to provide written informed consent to participate.
- Healthy, as determined by medical history, physical examination, and vital signs.
- Willing to receive the unlicensed (VAX102) vaccine given as an i.m. or s.c. injection.
- Willing to provide multiple blood specimens collected by venipuncture.
- Females should avoid becoming pregnant during the course of the study
- Women of childbearing potential must have a negative urine pregnancy test within 24 hours preceding receipt of the first and preceding receipt of the second (booster) vaccination.
- Must exhibit comprehension of the study requirements; expressed availability for the required study period and expect to reside in the study area during the entire study period, and ability to attend scheduled visits.
Exclusion
- Persons under 18 years old or 50 years or older.
- Persons with chronic illnesses such as cancer, diabetes, liver or kidney disease.
- Person currently pregnant, nursing mothers or planning a pregnancy within one month of vaccination.
- Persons who have had a prior serious reaction to influenza vaccine.
- Persons with a history of anaphylactic-type reaction to injected vaccines.
- Persons with a history of drug or chemical abuse in the year preceding the study.
- Persons who received an influenza vaccine for the current influenza season or those who plan to receive an influenza vaccine while participating in the study.
- Persons who received any other vaccine within one week prior to enrollment (may delay enrollment).
- Persons who have had a respiratory illness or illness with fever within three days of study enrollment (may delay enrollment).
- Persons currently participating in another research study involving any study medications (medicines or vaccines).
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00921947
Start Date
June 1 2009
End Date
August 1 2009
Last Update
August 24 2011
Active Locations (1)
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1
Jean Brown Research
Salt Lake City, Utah, United States, 84124