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A Double-Dose Safety Study of An Influenza Vaccine (Multimeric-001) Injected to Elderly Volunteers

2014-07-24 14:10:58 | BioPortfolio

Summary

This is 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.

Description

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 per injection and Cohort 2: 500 mcg per injection) with 30 subjects in each cohort. In each cohort, eligible subjects will be randomized to receive one of the following administrations (as two single IM injections with an interval of 21 days between each injection).

All participants will be immunized with a conventional trivalent vaccine on day 42.

There will be 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 will take place 21+2 days after his/her first injection, provided they are deemed fit to be dosed by a study physician.

DSMB must review the safety data obtained from cohorts 1 and 2 before approving their second injection and before dose escalation.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Conditions

Influenza

Intervention

Multimeric-001 250 mcg in PBS, Multimeric-001 250 mcg with Adjuvant, Placebo in PBS, Placebo with Adjuvant, Multimeric 500 mcg in PBS, Multimeric-001 500 mcg with Adjuvant, Vaxigrip

Location

Tasmc Crc
Tel Aviv
Israel

Status

Recruiting

Source

BiondVax Pharmaceuticals ltd.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:10:58-0400

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