Observational Study to Assess Safety of H1N1 Pandemic Influenza Vaccine
NCT ID: NCT00950456
Last Updated: 2015-10-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
3216 participants
OBSERVATIONAL
2009-11-30
2011-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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ECOLOGIC_OR_COMMUNITY
PROSPECTIVE
Study Groups
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H1N1 Pandemic Influenza Vaccine
Subjects will be enrolled and vaccinated according to national policy and standard practice.
H1N1 Pandemic Influenza Vaccine (whole virion, Vero Cell-derived, inactivated)
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.
Interventions
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H1N1 Pandemic Influenza Vaccine (whole virion, Vero Cell-derived, inactivated)
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* They will be administered CELVAPAN (= Baxter´s H1N1 pandemic influenza vaccine)
* They are 2 months of age or older at the time of first vaccine administration
* Their medical history is available
* The investigator believes they will comply with the foreseen vaccination schedule and will reliably observe signs or symptoms of adverse events during the observational period
* They and/or their parent(s)/legal guardian(s) provide written informed consent, and assent where appropriate, prior to study entry according to national law
Exclusion Criteria
* They have already been administered another H1N1 pandemic vaccine
* They have any contraindication to vaccination (as per the Summary of Product Characteristics and/or relevant national immunization guidelines)
2 Months
ALL
Yes
Sponsors
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Alachua Government Services, Inc.
INDUSTRY
Responsible Party
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Baxter Innovations GmbH
Principal Investigators
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Baxter BioScience Medical Director
Role: STUDY_DIRECTOR
Baxter Healthcare Corporation
Locations
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General Practice
Bludenz, , Austria
General Practice
Fulpmes, , Austria
General Practice
Hall in Tirol, , Austria
General Practice
Innsbruck, , Austria
Practice for Travel Medicine
Innsbruck, , Austria
City Council (Magistrat) Klagenfurt (Health & Food Department)
Klagenfurt, , Austria
General Practice
Kufstein, , Austria
General Practice
Mariapfarr, , Austria
General Practice
Oberperfuss, , Austria
General Practice
Salzburg, , Austria
General Practice
Telfs, , Austria
Medical University of Vienna, Department of Internal Medicine I, Division of Infectious Diseases and Tropical Medicine
Vienna, , Austria
Medical University of Vienna, Department of Specific Prophylaxis and Tropical Medicine
Vienna, , Austria
Hanusch Hospital
Vienna, , Austria
Wiener Gebietskrankenkasse (Health insurance center Vienna)
Vienna, , Austria
General Practice
Voitsberg, , Austria
General Practice
Wels, , Austria
Countries
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Other Identifiers
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820901
Identifier Type: -
Identifier Source: org_study_id
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