Status:
UNKNOWN
Safety and Reactogenicity of a PAL Combined With Seasonal Flu Vaccine in Healthy Adults
Lead Sponsor:
Folia Biotech Inc.
Conditions:
Flu
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
This is a phase 1, research study is looking at the safety and acceptability of a new vaccine adjuvant (immune booster) called PAL when combined with the seasonal flu vaccine (Fluviral) to test the sa...
Detailed Description
This is a phase 1, dose-ranging, randomized (5:1), observer-blind, controlled study of the safety and immune response to intramuscular injection of PapMV (Papaya Mosaic Virus) rVLP (Recombinant Virus-...
Eligibility Criteria
Inclusion
- Good general health status, as determined by history and physical examination no greater than 30 days prior to administration of the first test article.
- Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g. completion of Diary Cards, return for follow-up visits).
- If female of child-bearing potential and heterosexually active, has practiced adequate contraception for 30 days prior to injection and has a negative pregnancy test on the day of injection and has agreed to continue adequate contraception until 180 days after injection. (Please refer to the glossary for the definition of child-bearing potential and adequate contraception).
Exclusion
- Use of any investigational or non-registered product (drug or vaccine) other than the study product within 28 days preceding the dose of study product, or planned use during the study period.
- Planned administration/ administration of a vaccine/product not foreseen by the study protocol within the period starting 28 days before injection and ending 28 days after.
- Planned administration/ administration of the seasonal influenza vaccine recommended by local public health authorities within the period starting 120 days before injection and ending 121 days after. (Note: enrolment should be completed 120 days before the annual seasonal influenza vaccine campaigns in October and December)
- Administration of immunoglobulins and/or any blood products within the 3 months preceding the dose of study product or planned administration during the study period.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. (Laboratory testing for HIV, Hepatitis C and Hepatitis B will be performed during the screening visit).
- Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drug within 6 months prior to the product dose
- Family history of congenital or hereditary immunodeficiency.
- History of or current autoimmune disease.
- Known or suspected hypersensitivity to Fluviral, to thimerosal, or to any other ingredient in the formulation or component of the container.
- Pregnant or lactating female.
- Any hematological (hemoglobin level, white blood cell \[WBC\], and platelet count) and biochemical (alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\], blood urea nitrogen \[BUN\] and creatinine) abnormality as per local laboratory normal values considered clinically significant by the investigator.
- Any acute or chronic, clinically significant disease, as determined by physical examination or laboratory screening tests.
- Any other condition that the investigator judges may interfere with study procedures (e.g. drawing blood) or findings (e.g. immune response).
Key Trial Info
Start Date :
April 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2017
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT02188810
Start Date
April 1 2014
End Date
December 1 2017
Last Update
February 12 2016
Active Locations (1)
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1
Canadian Center for Vaccinology
Halifax, Nova Scotia, Canada, B3K 6R8