A Prospective Non-Interventional Observational Study to Assess the Safety of Two Vaccinations of a Vero Cell-Derived, Whole Virus H1N1 Pandemic Influenza Vaccine in Subjects Exposed to the Vaccine Through Policies by Governments or Health Authorities
Sponsor study identifier
observational
3,216
1 country
17
Study Start
November 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2010
Actual (reported)Study Completion
February 2011
Actual (reported)The purpose of this observational study, which will be initiated as soon as the licensed H1N1 Pandemic Influenza Vaccine is used in a mass vaccination campaign, is to estimate the incidence of any medically-attended adverse events in all vaccinated subjects.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2011
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 30, 2009
Actual (reported)July 31, 2009
Actual (reported)November 2009
Date type not reportedThis date has not been verified as actual or estimated.
December 2010
Actual (reported)February 2011
Actual (reported)Subjects will be enrolled and vaccinated according to national policy and standard practice.
It is anticipated that subjects will receive two intramuscular injections approximately 3 weeks apart. The vaccine will be provided in two doses, one for adults, the other for children.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
The enrollment of subjects in this study will follow national vaccination policy decisions in the UK.
General Practice
Bludenz, 6700, Austria
General Practice
Fulpmes, 6166, Austria
General Practice
Hall in Tirol, 6060, Austria
General Practice
Innsbruck, 6020, Austria
Practice for Travel Medicine
Innsbruck, 6020, Austria
City Council (Magistrat) Klagenfurt (Health & Food Department)
Klagenfurt, 9020, Austria
General Practice
Kufstein, 6330, Austria
Baxter BioScience Medical Director
Baxter Healthcare Corporation
3,216 participants (actual enrollment reported by the registry).
First Submitted
July 30, 2009
First Posted
July 31, 2009
Study Start
November 2009
Date type not reportedThis date has not been verified as actual or estimated.
Safety and Immunogenicity Study of a Booster Vaccination With a Non-Adjuvanted H5N1 Influenza Vaccine (Follow Up to Study 810501)
Contact the study team to confirm eligibility.
General Practice
Mariapfarr, 5571, Austria
General Practice
Oberperfuss, 6173, Austria
General Practice
Salzburg, 5020, Austria
General Practice
Telfs, 6410, Austria
Medical University of Vienna, Department of Internal Medicine I, Division of Infectious Diseases and Tropical Medicine
Vienna, 1090, Austria
Medical University of Vienna, Department of Specific Prophylaxis and Tropical Medicine
Vienna, 1090, Austria
Hanusch Hospital
Vienna, 1100, Austria
Wiener Gebietskrankenkasse (Health insurance center Vienna)
Vienna, 1100, Austria
General Practice
Voitsberg, 8570, Austria
General Practice
Wels, 4600, Austria
Primary Completion
December 2010
Actual (reported)Study Completion
February 2011
Actual (reported)Last Updated
October 9, 2015
Record last verified: 2011-05
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Source: ClinicalTrials.gov.
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