Observational Study to Assess Safety of H1N1 Pandemic Influenza Vaccine

Influenza Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00950456
• Other study ID #: 820901
• 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

• Influenza
• Influenza, Human
• Pandemic Influenza

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,