Trial document




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  DRKS00003253

Trial Description

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Title

Influenza vaccination with PREFLUCEL: vaccination motivation and tolarability

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Vaccinations are some of the most important and most effective methods in preventive medicine. However, the vaccination coverage rates in Germany are too low in many areas, incl. influenza vaccination, often caused by the fear of patients and also physicians of adverse reactions. Therefore, the good tolerability of vaccines is of essential importantance and the specific education of people is a substantial part in encouraging vaccination. The purpose of this non-interventional study is to find out how physicians promote for the seasonal influenza vaccination (once per site using a separate questionnaire), to collect the patients' reasons for vaccination and to document the tolerability of the Vero cell technology based new influenza vaccine PREFLUCEL in routine practice.
Patients 18 years and older who have been vaccinated with PREFLUCEL for influenza prophylaxis and who signed a written informed consent to participate in the non-interventional study are eligible to participate.
The patient's basic data is documented once in a questionnaire. About 4 weeks after vaccination the physician should evaluate
the tolerability of the vaccination on the same questionnaire.
Adverse events are documented on separate questionnaires,
if applicable.

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00003253
  •   2011/09/07
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  •   no
  •   Approved
  •   011/1581, Freiburger Ethik-Kommission International
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Secondary IDs

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Health Condition or Problem studied

  •   J11.1 -  Influenza with other respiratory manifestations, virus not identified
  •   Influenza prophylaxis in adults and older persons
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Interventions/Observational Groups

  •   At Baseline, the basic data of patients vaccinated with PREFLUCEL is documented in the CRF once (demographics, concomitant diseases, data on previous influenza vaccinations, the patient's motivation for vaccination, indications acc. to STIKO, key data of PREFLUCEL vaccination). In addition, each site should document on a separate questionnaire how they encourage their patients to get the seasonal influenza vaccination. Approximately 4 weeks after the vaccination the tolerability of the vaccination and possible adverse events should be documented.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Prevention
  •   Single (group)
  •   N/A
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Primary Outcome

Identify methods for motivating patients for influenza vaccination in practices: once per site on a separate questionnaire.
Collect patients' motivation and indication for influenza vaccination: once in the CRF.
Document the tolerability of the PREFLUCEL vaccination after about 4 weeks in the CRF.

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Secondary Outcome

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Actual
  •   2011/09/12
  •   1200
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Patients who have been vaccinated with PREFLUCEL for influenza prophylaxis and who signed a written informed consent to participate in this non-interventional study.

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Exclusion Criteria

no exclusion criteria

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Addresses

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    • Baxter Deutschland GmbH  
    • Edisonstraße 4
    • 85716   Unterschleißheim
    • Germany
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    • Baxter Deutschland GmbH      
    • Ms.  Dr. med.   Anja   Reichert 
    • Edisonstraße 4
    • 85716   Unterschleißheim
    • Germany
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    • Baxter Deutschland GmbH  
    • Ms.  Dr. med.   Anja   Reichert 
    • Edisonstraße 4
    • 85716   Unterschleißheim
    • Germany
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Sources of Monetary or Material Support

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    • Baxter Deutschland GmbH  
    • Edisonstraße 4
    • 85716   Unterschleißheim
    • Germany
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    •   Tel.: 089 31701- 448
    •   Fax: 089 31701- 584
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    •   http://www.baxter.com
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Status

  •   Recruiting stopped after recruiting started
  •   2011/11/21
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.