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Clinical Trials/DRKS00000277
DRKS00000277
Completed
Not Applicable

Hospital-based case control study to assess vaccine effectiveness against Novel Influenza A (H1N1) and occurance of severe acute respiratory infections (SARI) in adults between 18 and 65 years of age in Berlin, 2009-10 - Influenza-Impfeffektivitätsstudie (IIE-Studie)

Robert Koch-Institut, Abteilung für Infektionsepidemiologie0 sites478 target enrollmentDecember 9, 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
2009 Novel Influenza A (H1N1)
Sponsor
Robert Koch-Institut, Abteilung für Infektionsepidemiologie
Enrollment
478
Status
Completed
Last Updated
last year

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
December 9, 2009
End Date
TBD
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Robert Koch-Institut, Abteilung für Infektionsepidemiologie

Eligibility Criteria

Inclusion Criteria

  • A resident of Berlin,
  • a) who is hospitalized in one of the participating clinics of the Vivantes network, AND
  • b) who is between 18 and 65 years old, AND
  • c) who gave written informed consent to participate in the study, AND
  • d) who is hospitalized due to an acute respiratory illness, defined as presence of the following symptoms in the past 10 days
  • \- at least one systemic symptom: fever, or chills, or musclepain, or headache, AND
  • \- at least one respiratory symptom: cough or sore throat
  • \- a suspected diagnosis of influenza, acute bronchitis, or pneumonia assessed by a medical doctor

Exclusion Criteria

  • a) who can not give written informed consent
  • b) who have insufficient capability to communicate for medical reasons like aphasia or unconsciousness
  • c) who live in a nursing home
  • d) who have a history of severe anaphlaxis after vaccination
  • e) who already had 14 days or earlier before hospitalization the diagnosis of 2009 Novel Influenza confirmed by PCR

Outcomes

Primary Outcomes

Not specified

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