- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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
Studieöversikt
Detaljerad beskrivning
Studietyp
Inskrivning (Faktisk)
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Occurrences of potentially influenza-attributable hospitalization or death by age, risk status, region and season.
Tidsram: 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.
Tidsram: 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)
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Influenza vaccine content and effectiveness by season.
Tidsram: 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.
Tidsram: 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)
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 116730 (Western University's Research Ethics Board)
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