- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00626808
A Post Marketing Evaluation of the Effectiveness of FluMist Risk Minimization Plan in Children
21. juli 2014 opdateret af: MedImmune LLC
A Post Marketing Evaluation of the Effectiveness of the Risk Minimization Plan For Use of FluMist Among Children Less Than 5 Years of Age
This is a retrospective cohort study of children included in a large medical insurance claims database.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
To evaluate the rate of FluMist administration compared to other influenza vaccine use in the following pediatric populations:
- Children younger than 24 months of age
- Children 24-59 months of age with a claim associated with a diagnosis of asthma
- Children 24-59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing
- Children 24-59 months of age with immunosuppression
- To describe, in children in the above populations who receive FluMist, the type and number of Emergency Room visits or hospitalizations associated with an insurance claim within 42 days of receiving FluMist
- To explore the rationale for FluMist immunization of pediatric populations that are excluded from recommended usage by characterizing the use in these populations
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
321697
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
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North Carolina
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Research Triangle, North Carolina, Forenede Stater
- Research Site
-
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Children < 60 months of age.
Beskrivelse
- Children less than 24 months of age during August through January/February.
Children <24 to 59 months of age during August through January/February, with:
- two outpatient claims for asthma, or
- one inpatient/emergency room claim for asthma, or
- one outpatient claim for asthma and at least one SABA prescription during a defined 12-month period.
- Children <24 to 59 months of age during August through January/February, without any claims associated with a diagnosis of asthma, but with at least one dispensing for SABA, as indicated by pharmacy claims during a defined 12-month period.
- Children 24 to 59 months of age during August to January/February with evidence of immunosuppression prior to the date of influenza vaccination based on available medical and pharmacy claims.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Kohorte
- Tidsperspektiver: Tilbagevirkende kraft
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
---|---|
1
Children less than 24 months of age
|
There were no interventions.
No subjects were enrolled in this retrospective database study.
|
2
Children 24 to 59 months of age with a claim associated with a diagnosis of asthma
|
There were no interventions.
No subjects were enrolled in this retrospective database study.
|
3
Children 24 to 59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing
|
There were no interventions.
No subjects were enrolled in this retrospective database study.
|
4
Children 24-59 months of age with immunosuppression
|
There were no interventions.
No subjects were enrolled in this retrospective database study.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
FluMist Use in Participants up to 59 Months of Age
Tidsramme: 2009-2010
|
Among participants up to 59 months of age who received any flu vaccine, number who received FluMist
|
2009-2010
|
Vaccinating Physician Specialty: Pediatrician or Pediatric Specialist
Tidsramme: 2009-2010
|
Specialty of vaccinating physician who provided FluMist.
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2009-2010
|
Vaccinating Physician Specialty: General/Family Practitioner
Tidsramme: 2009-2010
|
Specialty of vaccinating physician who provided FluMist
|
2009-2010
|
Vaccinating Physician Specialty: Other
Tidsramme: 2009-2010
|
Specialty of vaccinating physician who provided FluMist
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2009-2010
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Vaccinating Physician Specialty: Unknown
Tidsramme: 2009-2010
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Specialty of vaccinating physician who provided FluMist
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2009-2010
|
Geographic Region: Northeastern
Tidsramme: 2009-2010
|
Geographic region of parents' residence among participants receiving FluMist
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2009-2010
|
Geographic Region: North Central
Tidsramme: 2009-2010
|
Geographic region of parents' residence among participants receiving FluMist
|
2009-2010
|
Geographic Region: Southern
Tidsramme: 2009-2010
|
Geographic region of parents' residence among participants receiving FluMist
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2009-2010
|
Geographic Region: Western
Tidsramme: 2009-2010
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Geographic region of parents' residence among participants receiving FluMist
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2009-2010
|
Number of Outpatient Visits: 0
Tidsramme: 2009-2010
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Among participants vaccinated with FluMist, the number who had 0 outpatient visits in the 3 months prior to vaccination
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2009-2010
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Number of Outpatient Visits: 1
Tidsramme: 2009-2010
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Among participants vaccinated with FluMist, the number who had 1 outpatient visit in the 3 months prior to vaccination
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2009-2010
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Number of Outpatient Visits: 2 or More
Tidsramme: 2009-2010
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Among participants vaccinated with FluMist, the number who had 2 or more outpatient visits in the 3 months prior to vaccination
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2009-2010
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Number of Days With a Respiratory Claim in 28 Days Prior to Vaccination: 0
Tidsramme: 2009-2010
|
Among participants vaccinated with FluMist, the number of days with a respiratory claim (asthma, acute respiratory distress, bronchospasm, influenza, respiratory syncytial virus, bronchiolitis, bronchitis, pneumonia, croup, sinusitis, adenovirus infection, coxsackie virus infection, rhinovirus infection, nasopharyngitis, laryngitis and tracheitis, upper respiratory infection, cough) in the 28 days prior to vaccination.
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2009-2010
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Number of Days With a Respiratory Claim in 28 Days Prior to Vaccination: 1
Tidsramme: 2009-2010
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Among participants vaccinated with FluMist, the number of days with a respiratory claim (asthma, acute respiratory distress, bronchospasm, influenza, respiratory syncytial virus, bronchiolitis, bronchitis, pneumonia, croup, sinusitis, adenovirus infection, coxsackie virus infection, rhinovirus infection, nasopharyngitis, laryngitis and tracheitis, upper respiratory infection, cough) in the 28 days prior to vaccination.
|
2009-2010
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Number of Days With a Respiratory Claim in 28 Days Prior to Vaccination: 2 or More
Tidsramme: 2009-2010
|
Among participants vaccinated with FluMist, the number of days with a respiratory claim (asthma, acute respiratory distress, bronchospasm, influenza, respiratory syncytial virus, bronchiolitis, bronchitis, pneumonia, croup, sinusitis, adenovirus infection, coxsackie virus infection, rhinovirus infection, nasopharyngitis, laryngitis and tracheitis, upper respiratory infection, cough) in the 28 days prior to vaccination.
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2009-2010
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Studieleder: Chris Ambrose, M.D., MedImmune LLC
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. oktober 2007
Primær færdiggørelse (Faktiske)
1. marts 2010
Studieafslutning (Faktiske)
1. marts 2010
Datoer for studieregistrering
Først indsendt
20. februar 2008
Først indsendt, der opfyldte QC-kriterier
20. februar 2008
Først opslået (Skøn)
29. februar 2008
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
12. august 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
21. juli 2014
Sidst verificeret
1. juli 2014
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- MI-MA175
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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