Influenza Clinical Trial
Official title:
A Phase I/II, Randomized, Single-Blind, Placebo-Controlled Escalating Double-Dose, Safety and Priming Potential Study of an Intramuscular Influenza Vaccine (Multimeric-001) Injected to Elderly Volunteers
This is a phase I/II, randomized, single-blind, placebo-controlled escalating double-dose study of the safety and priming potential of an intramuscular Influenza vaccine (Multimeric-001) injected to elderly volunteers.
This is a Phase I/II single-center, randomized, placebo-controlled, single-blind,
dose-escalation, double-dose administration study comprising two dosing cohorts (Cohort 1:
250 mcg M-001 per injection and Cohort 2: 500 mcg M-001 per injection) with 20 subjects in
each cohort receiving either adjuvanted or non-adjuvanted formulations. The adjuvant used
was Montanide ISA VG51. Cohort 3 with 20 subjects was administered placebo. After priming
with M-001 or placebo, all participants were administered a boost of a conventional
trivalent vaccine on day 42.
There was a minimum of 10 days interval between last dosing of the first injection to the
last subject of the 250 μg cohort (Cohort 1) and first dosing of the first subject injection
with 500 µg cohort (Cohort 2).
For each subject, the second injection was performed 21+2 days after his/her first
injection, provided they were deemed fit to be dosed by a study physician.
The DSMB reviewed the safety data obtained from cohorts 1 and 2 before approving their
second injection and before dose escalation.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
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