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A Study to Determine the Immunogenicity and Safety of CSL Limited's Influenza Virus Vaccine Compared to a US Licensed Comparator Influenza Virus Vaccine in a Pediatric Population

2014-08-27 03:20:02 | BioPortfolio

Summary

The purpose of this study is to determine the immunogenicity and safety of CSL Limited's Influenza Virus Vaccine compared to a US licensed comparator Influenza Virus Vaccine in a pediatric population aged greater than or equal to 6 months to less than 18 years.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Conditions

Influenza

Intervention

CSL's Influenza Virus Vaccine (Afluria), Influenza Virus Vaccine (Fluzone)

Location

Cincinnati Children's Hospital Medical Center- Division of Infectious Disease
Chandler
Arizona
United States
85224

Status

Completed

Source

CSL Limited

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:20:02-0400

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Medical and Biotech [MESH] Definitions

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.

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A subtype of INFLUENZA A VIRUS that is highly virulent in poultry and wild birds, but shows varying degrees of pathogenicity in mice. The H5N8 virus subtype has a polybasic amino acid motif at the HA cleavage site which explains its pathogenicity in birds, and expresses surface proteins HEMAGGLUTININ 5 and NEURAMINIDASE 8 which are typical of Highly Pathogenic Avian Influenza viruses.

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