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

Conditions: 2009 Novel Influenza A (H1N1)

Registration Number: DRKS00000277

Lead Sponsor: Robert Koch-Institut, Abteilung für Infektionsepidemiologie

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 478

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
OR
- a suspected diagnosis of influenza, acute bronchitis, or pneumonia assessed by a medical doctor

Exclusion Criteria

Patients,
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

Study & Design

Study Type: observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assessment of the effectiveness of pandemic influenza vaccines to prevent hospitalization due to acute respiratory illness or due to laboratory-confirmed infection with Novel Influenza A (H1N1) among adults between 18-65 years of age

Secondary Outcome Measures

Name	Time	Method
Assessment and description of the disease burden of severe acute respiratory illness among adults between 18-65 years in Berlin on a weekly basis during the flu season 2009/10 \|\| Description of clinical manifestations and complications among patients between 18-65 years of age, who are hospitalized due to 2009 Novel Influenza A (H1N1), and the identification of risk factors for severe disease