Influenza Clinical Trial
Official title:
A Phase II, Randomized, Placebo-Controlled, Double-Blind Study to Assess the Safety and Immunogenicity of Multimeric-001 Influenza Vaccine, Followed by a Seasonal Trivalent Influenza Vaccine (TIV)
This is a single-site, randomized, double-blind, placebo-controlled study of Multimeric-001
in thirty six (36) volunteers 50-65 years of age.
All subjects will receive an intramuscular (IM) injection, in each one of three visits, with
a 21±2 days interval between treatments.
Subjects will undergo screening procedures within 30 days prior to first vaccination which
will include medical history, vital signs, ECG, physical examination and safety blood and
urine lab tests.
On the first treatment visit, eligible subjects will undergo pre-dose physical examination
and vital signs, and a blood sample will be drawn for baseline cellular immunogenicity and
circulating Interferon gamma (IFN-g). They will then receive an IM injection of either
vaccine or placebo, according to the above treatment assignment, into the deltoid muscle
preferably of the same arm. The subjects will remain under medical supervision for 2 hrs (±
15 min) at which time they will be released from the Clinical research center.
The second treatment will take place 21 (±2) days after the first vaccination. Procedures
will be the same as that of Visit 2 Additional two follow-up visits will take place at
approximately 24 hrs and 48h The third treatment will take place 21 (±2) days after the
second vaccination. Procedures will be the same as that of Visit 2 21 days later, each
subject will be immunized with the seasonal influenza vaccine approved for 2014/15 year.
A Study Termination visit will take place at 21 (±2) days after last vaccination. Adverse
events (AEs) and changes in concomitant medications will be recorded, vital signs will be
measured and the subjects will undergo physical examination and ECG. Blood and urine samples
will be collected for safety.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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