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Observational Study to Assess Safety of H1N1 Pandemic Influenza Vaccine

This study has been completed.
Sponsor:
Information provided by:
Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:
NCT00950456
First received: July 30, 2009
Last updated: May 11, 2011
Last verified: May 2011
History of Changes
  Purpose

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.


Condition Intervention
Influenza
Pandemic Influenza
 Biological: H1N1 Pandemic Influenza Vaccine (whole virion, Vero Cell-derived, inactivated)

Study Type: Observational
Study Design: Observational Model: Ecologic or Community
Time Perspective: Prospective
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

Resource links provided by NLM:

MedlinePlus related topics: Flu
U.S. FDA Resources

Further study details as provided by Baxter Healthcare Corporation:

Enrollment: 3216
Study Start Date: November 2009
Study Completion Date: February 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
H1N1 Pandemic Influenza Vaccine
Subjects will be enrolled and vaccinated according to national policy and standard practice.
 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.
Other Name: CELVAPAN

  Eligibility

Ages Eligible for Study:   2 Months and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

The enrollment of subjects in this study will follow national vaccination policy decisions in the UK.

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00950456

Locations
Austria
General Practice
Bludenz, Austria, 6700
General Practice
Fulpmes, Austria, 6166
General Practice
Hall in Tirol, Austria, 6060
General Practice
Innsbruck, Austria, 6020
Practice for Travel Medicine
Innsbruck, Austria, 6020
City Council (Magistrat) Klagenfurt (Health & Food Department)
Klagenfurt, Austria, 9020
General Practice
Kufstein, Austria, 6330
General Practice
Mariapfarr, Austria, 5571
General Practice
Oberperfuss, Austria, 6173
General Practice
Salzburg, Austria, 5020
General Practice
Telfs, Austria, 6410
Medical University of Vienna, Department of Internal Medicine I, Division of Infectious Diseases and Tropical Medicine
Vienna, Austria, 1090
Medical University of Vienna, Department of Specific Prophylaxis and Tropical Medicine
Vienna, Austria, 1090
Hanusch Hospital
Vienna, Austria, 1100
Wiener Gebietskrankenkasse (Health insurance center Vienna)
Vienna, Austria, 1100
General Practice
Voitsberg, Austria, 8570
General Practice
Wels, Austria, 4600
Sponsors and Collaborators
Baxter Healthcare Corporation
Investigators
Study Director: Baxter BioScience Medical Director Baxter Healthcare Corporation
  More Information

No publications provided

Responsible Party: David Perry, MD; Sponsor´s signatory, Baxter Innovations GmbH
ClinicalTrials.gov Identifier: NCT00950456     History of Changes
Other Study ID Numbers: 820901
Study First Received: July 30, 2009
Last Updated: May 11, 2011
Health Authority: Austria: Agency for Health and Food Safety

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
 Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 16, 2013