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Study to Evaluate Immunogenicity and Safety of an Investigational Influenza Vaccine (H1N1)

11:26 EDT 17th April 2014 | BioPortfolio

Summary

This trial will assess the immunogenicity and safety elicited by the adjuvanted GSK Biologicals' influenza investigational vaccine GSK2340274A in healthy Japanese adults aged 20-64 years.

Description

This Protocol Posting has been updated following Protocol amendment 1& 2, October 2009. The sections impacted are study design and outcome measures

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Conditions

Influenza Infection

Intervention

Influenza investigational vaccine GSK2340274A

Location

GSK Investigational Site
Fukuoka
Japan
813-0025

Status

Completed

Source

GlaxoSmithKline

Results (where available)

View Results

Links

Medical and Biotech [MESH] Definitions

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.

Vaccines used to prevent infection by viruses in the family ORTHOMYXOVIRIDAE. It includes both killed or attenuated vaccines. The composition of the vaccines is changed each year in response to antigenic shifts and changes in prevalence of influenza virus strains. The vaccine is usually bivalent or trivalent, containing one or two INFLUENZAVIRUS A strains and one INFLUENZAVIRUS B strain.

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.

A genus of the family ORTHOMYXOVIRIDAE comprising viruses similar to types A and B but less common, more stable, more homogeneous, and lacking the neuraminidase protein. They have not been associated with epidemics but may cause mild influenza. Influenza C virus is the type species.

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