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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00950456
Other study ID # 820901
Secondary ID
Status Completed
Phase N/A
First received July 30, 2009
Last updated October 7, 2015
Start date November 2009
Est. completion date February 2011

Study information

Verified date May 2011
Source Nanotherapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority Austria: Agency for Health and Food Safety
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 3216
Est. completion date February 2011
Est. primary completion date December 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 2 Months and older
Eligibility 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)

Study Design

Observational Model: Ecologic or Community, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Biological:
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.

Locations

Country Name City State
Austria 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 Hanusch Hospital Vienna
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 Wiener Gebietskrankenkasse (Health insurance center Vienna) Vienna
Austria General Practice Voitsberg
Austria General Practice Wels

Sponsors (1)

Lead Sponsor Collaborator
Nanotherapeutics, Inc.

Country where clinical trial is conducted

Austria, 

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