- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01599390
Influenza Burden Assessment in the United States, July1997 - up to April 2009
Burden of Influenza in the United States, July 1997 up to April 2009
Studieoversigt
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Recorded in the US NIS hospitalization data or the US National Vital Statistics System (NVSS) mortality data with a pre-specified diagnostic code.
Exclusion Criteria:
- Missing data in the following fields: age, primary discharge diagnosis, admission month (NIS) /month of death (NVSS), and status at discharge (alive / dead).
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
Influenza Group
|
The study will use multiple primary data sources: the Nationwide Inpatient Sample (for hospitalisations) and the US National Vital Statistics System (for mortality), and weekly virology data from the Centers for Disease Control and Prevention (CDC) influenza surveillance program supplemented with literature data. Weekly time series of the rates of various severe influenza-related health outcomes will be constructed. Statistical models, guided by weekly numbers of cases of laboratory-confirmed influenza and respiratory syncytial virus (RSV) contained in the CDC virology data, will be constructed to estimate the portions of the various outcomes that can be attributed to influenza. Next, the seasonal impact of influenza by age, risk status, and influenza subtype will be assessed. Finally, the potential burden that a quadrivalent vaccine could have prevented over the 12 year study period will be predicted. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Occurrences of potentially influenza-attributable hospitalization or death by age, risk status, region and season.
Tidsramme: From July 1997 to April 2009 (i.e., up to almost 12 years)
|
From July 1997 to April 2009 (i.e., up to almost 12 years)
|
|
Amount of circulating influenza A and B, and RSV strains determined for each season.
Tidsramme: From July 1997 to April 2009 (i.e., up to almost 12 years)
|
From July 1997 to April 2009 (i.e., up to almost 12 years)
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Influenza vaccine content and effectiveness by season.
Tidsramme: From July 1997 to April 2009 (i.e., up to almost 12 years)
|
From July 1997 to April 2009 (i.e., up to almost 12 years)
|
|
Influenza vaccine coverage by season.
Tidsramme: From July 1997 to April 2009 (i.e., up to almost 12 years)
|
From July 1997 to April 2009 (i.e., up to almost 12 years)
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 116730 (Western University's Research Ethics Board)
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