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Study of Further Investigation of an Intramuscular Influenza Vaccine (Multimeric-001)

2014-08-27 03:12:49 | BioPortfolio

Summary

This is a multi-center, randomized, two stage, double-blind, placebo-controlled, two-dose administration study comprising 160 healthy participants.

Description

This is a Phase II multi-center, randomized, two stage, double-blind, placebo-controlled, two-dose administration study comprising 160 participants. 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 Administration A: Adjuvanted Multimeric-001 500 mcg - eighty (80) subjects.

Administration B: PBS (Placebo), - forty (40) subjects. Administration C: Adjuvanted PBS (Placebo), - forty (40) subjects. Participants from administrations A and B will be further immunized with a 15% dose of commercial seasonal trivalent vaccine for 2011 on day 81.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Conditions

Influenza

Intervention

Multimeric-001, 500 mcg, Phosphate Buffered Saline (PBS) adjuvanted, Adjuvanted PBS, 0.2 ml

Location

Clinical Research Center, Hadassah Medical Center
Jerusalem
Israel

Status

Not yet recruiting

Source

BiondVax Pharmaceuticals ltd.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:12:49-0400

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Medical and Biotech [MESH] Definitions

A sodium fluoride solution, paste or powder, which has been acidulated to pH 3 to 4 and buffered with a phosphate. It is used in the prevention of dental caries.

Species of the genus INFLUENZAVIRUS B that cause HUMAN INFLUENZA and other diseases primarily in humans. Antigenic variation is less extensive than in type A viruses (INFLUENZA A VIRUS) and consequently there is no basis for distinct subtypes or variants. Epidemics are less likely than with INFLUENZA A VIRUS and there have been no pandemics. Previously only found in humans, Influenza B virus has been isolated from seals which may constitute the animal reservoir from which humans are exposed.

Membrane glycoproteins from influenza viruses which are involved in hemagglutination, virus attachment, and envelope fusion. Fourteen distinct subtypes of HA glycoproteins and nine of NA glycoproteins have been identified from INFLUENZA A VIRUS; no subtypes have been identified for Influenza B or Influenza C viruses.

Infection of domestic and wild fowl and other BIRDS with INFLUENZA A VIRUS. Avian influenza usually does not sicken birds, but can be highly pathogenic and fatal in domestic POULTRY.

A genus of HALOBACTERIACEAE distinguished from other genera in the family by the presence of specific derivatives of TGD-2 polar lipids. Haloarcula are found in neutral saline environments such as salt lakes, marine salterns, and saline soils.

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