Observational Study to Assess Safety of H1N1 Pandemic Influenza Vaccine

October 7, 2015 updated by: Ology Bioservices

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

3216

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Bludenz, Austria, 6700
        • General Practice
      • Fulpmes, Austria, 6166
        • General Practice
      • Hall in Tirol, Austria, 6060
        • General Practice
      • Innsbruck, Austria, 6020
        • General Practice
      • Innsbruck, Austria, 6020
        • Practice for Travel Medicine
      • Klagenfurt, Austria, 9020
        • City Council (Magistrat) Klagenfurt (Health & Food Department)
      • Kufstein, Austria, 6330
        • General Practice
      • Mariapfarr, Austria, 5571
        • General Practice
      • Oberperfuss, Austria, 6173
        • General Practice
      • Salzburg, Austria, 5020
        • General Practice
      • Telfs, Austria, 6410
        • General Practice
      • Vienna, Austria, 1090
        • 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, 1100
        • Hanusch Hospital
      • Vienna, Austria, 1100
        • Wiener Gebietskrankenkasse (Health insurance center Vienna)
      • Voitsberg, Austria, 8570
        • General Practice
      • Wels, Austria, 4600
        • General Practice

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 months and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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 Names:
  • CELVAPAN

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ology Bioservices

Investigators

  • Study Director: Baxter BioScience Medical Director, Baxter Healthcare Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

February 1, 2011

Study Registration Dates

First Submitted

July 30, 2009

First Submitted That Met QC Criteria

July 30, 2009

First Posted (Estimate)

July 31, 2009

Study Record Updates

Last Update Posted (Estimate)

October 9, 2015

Last Update Submitted That Met QC Criteria

October 7, 2015

Last Verified

May 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 820901

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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