Clinical trial NCT00950456: Observational Study to Assess Safety of H1N1 Pandemic Influenza Vaccine
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Influenza
Pandemic Influenza
Lead sponsor: Resilience Government Services, Inc.
Sponsor class: INDUSTRY
First posted: 2009-07-31
Enrollment: 3216
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The enrollment of subjects in this study will follow national vaccination policy decisions in the UK.

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

Male and female subjects, per indication on license or per official vaccine recommendations, will be eligible for participation in this study if:

* 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:

Male and female subjects will be excluded from participation in this study if:

* 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)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bludenz
country: Austria
facility: General Practice
city: Fulpmes
country: Austria
facility: General Practice
city: Hall in Tirol
country: Austria
facility: General Practice
city: Innsbruck
country: Austria
facility: General Practice
city: Innsbruck
country: Austria
facility: Practice for Travel Medicine
city: Klagenfurt
country: Austria
facility: City Council (Magistrat) Klagenfurt (Health & Food Department)
city: Kufstein
country: Austria
facility: General Practice
city: Mariapfarr
country: Austria
facility: General Practice
city: Oberperfuss
country: Austria
facility: General Practice
city: Salzburg
country: Austria
facility: General Practice
city: Telfs
country: Austria
facility: General Practice
city: Vienna
country: Austria
facility: Medical University of Vienna, Department of Internal Medicine I, Division of Infectious Diseases and Tropical Medicine
city: Vienna
country: Austria
facility: Medical University of Vienna, Department of Specific Prophylaxis and Tropical Medicine
city: Vienna
country: Austria
facility: Hanusch Hospital
city: Vienna
country: Austria
facility: Wiener Gebietskrankenkasse (Health insurance center Vienna)
city: Voitsberg
country: Austria
facility: General Practice
city: Wels
country: Austria
facility: General Practice
Study officials:
affiliation: Baxter Healthcare Corporation
name: Baxter BioScience Medical Director
role: STUDY_DIRECTOR
References: