Observational Study to Assess Safety of H1N1 Pandemic Influenza Vaccine

Completed

• Conditions: Influenza; Pandemic Influenza
• Interventions: Biological: H1N1 Pandemic Influenza Vaccine (whole virion, Vero Cell-derived, inactivated)

• Registration Number: NCT00950456
• Lead Sponsor: Resilience Government Services, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-07-30
• Study First Submitted QC: 2009-07-30
• Study First Posted: 2009-07-31
• Study Start: 2009-11
• Primary Completion: 2010-12
• Study Completion: 2011-02
• Status Verified: 2011-05
• Last Update Submitted: 2015-10-07
• Last Update Posted: 2015-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3216

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

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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)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
H1N1 Pandemic Influenza Vaccine	H1N1 Pandemic Influenza Vaccine (whole virion, Vero Cell-derived, inactivated)	Subjects will be enrolled and vaccinated according to national policy and standard practice.

Trial Locations

Locations (7)

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

City Council (Magistrat) Klagenfurt (Health & Food Department); 🇦🇹 Klagenfurt, Austria

Practice for Travel Medicine; 🇦🇹 Innsbruck, Austria

Medical University of Vienna, Department of Internal Medicine I, Division of Infectious Diseases and Tropical Medicine; 🇦🇹 Vienna, Austria

General Practice; 🇦🇹 Wels, Austria