Study of the Influenza Vaccine (Split Virion, Inactivated) Northern Hemisphere 2009-2010 Formulation (Intradermal Route)
Summary
This study is in support of the annual application for the variation of the vaccine strains for a marketing authorisation.
Objectives:
- To evaluate compliance, in terms of immunogenicity, of the corresponding strength of the intradermal (ID) influenza vaccine Northern Hemisphere (NH) 2009-2010 formulation.
- To describe the safety of the corresponding strength of the ID influenza vaccine, NH 2009-2010 formulation.
Study Design
Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Conditions
Influenza
Intervention
Influenza virus vaccine 2009-2010 formulation, Influenza virus vaccine 2009-2010 formulation
Location
Angers
France
49000
Status
Completed
Source
Sanofi-Aventis
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00945438
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Influenza B Virus
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.
Hemagglutinin Glycoproteins, Influenza Virus
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.
Influenza A Virus, H1n2 Subtype
A subtype of INFLUENZA A VIRUS comprised of the surface proteins hemagglutinin 1 and neuraminidase 2. It is endemic in both human and pig populations.
Influenza A Virus, H7n2 Subtype
A subtype of INFLUENZA A VIRUS comprised of the surface proteins hemagglutinin 7 and neuraminidase 2. It has been involved in a number of outbreaks in the 21st century on poultry farms and has been isolated a few times in humans.
Influenza A Virus, H10n7 Subtype
A subtype of INFLUENZA A VIRUS comprised of the surface proteins hemagglutinin 10 and neuraminidase 7. It has been isolated from a variety of wild and domestic animals including ducks, emu, and mink. It was found for the first time in humans in 2004.
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