A Post Marketing Evaluation of the Effectiveness of FluMist Risk Minimization Plan in Children
21. juli 2014 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert 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
Studietype
Observasjonsmessig
Registrering (Faktiske)
321697
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
North Carolina
-
Research Triangle, North Carolina, Forente stater
- Research Site
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: Kohort
- Tidsperspektiver: Retrospektiv
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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.
|
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
|
2009-2010
|
|
Vaccinating Physician Specialty: Unknown
Tidsramme: 2009-2010
|
Specialty of vaccinating physician who provided FluMist
|
2009-2010
|
|
Geographic Region: Northeastern
Tidsramme: 2009-2010
|
Geographic region of parents' residence among participants receiving FluMist
|
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
|
2009-2010
|
|
Geographic Region: Western
Tidsramme: 2009-2010
|
Geographic region of parents' residence among participants receiving FluMist
|
2009-2010
|
|
Number of Outpatient Visits: 0
Tidsramme: 2009-2010
|
Among participants vaccinated with FluMist, the number who had 0 outpatient visits in the 3 months prior to vaccination
|
2009-2010
|
|
Number of Outpatient Visits: 1
Tidsramme: 2009-2010
|
Among participants vaccinated with FluMist, the number who had 1 outpatient visit in the 3 months prior to vaccination
|
2009-2010
|
|
Number of Outpatient Visits: 2 or More
Tidsramme: 2009-2010
|
Among participants vaccinated with FluMist, the number who had 2 or more outpatient visits in the 3 months prior to vaccination
|
2009-2010
|
|
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.
|
2009-2010
|
|
Number of Days With a Respiratory Claim in 28 Days Prior to Vaccination: 1
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.
|
2009-2010
|
|
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.
|
2009-2010
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Studieleder: Chris Ambrose, M.D., MedImmune LLC
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. oktober 2007
Primær fullføring (Faktiske)
1. mars 2010
Studiet fullført (Faktiske)
1. mars 2010
Datoer for studieregistrering
Først innsendt
20. februar 2008
Først innsendt som oppfylte QC-kriteriene
20. februar 2008
Først lagt ut (Anslag)
29. februar 2008
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
12. august 2014
Siste oppdatering sendt inn som oppfylte QC-kriteriene
21. juli 2014
Sist bekreftet
1. juli 2014
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- MI-MA175
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .