A Post Marketing Evaluation of the Effectiveness of FluMist Risk Minimization Plan in Children
21 juli 2014 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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
Observationeel
Inschrijving (Werkelijk)
321697
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
-
-
North Carolina
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Research Triangle, North Carolina, Verenigde Staten
- Research Site
-
-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Bemonsteringsmethode
Niet-waarschijnlijkheidssteekproef
Studie Bevolking
Children < 60 months of age.
Beschrijving
- 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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Observatiemodellen: Cohort
- Tijdsperspectieven: Retrospectief
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
|
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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
FluMist Use in Participants up to 59 Months of Age
Tijdsspanne: 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
Tijdsspanne: 2009-2010
|
Specialty of vaccinating physician who provided FluMist.
|
2009-2010
|
|
Vaccinating Physician Specialty: General/Family Practitioner
Tijdsspanne: 2009-2010
|
Specialty of vaccinating physician who provided FluMist
|
2009-2010
|
|
Vaccinating Physician Specialty: Other
Tijdsspanne: 2009-2010
|
Specialty of vaccinating physician who provided FluMist
|
2009-2010
|
|
Vaccinating Physician Specialty: Unknown
Tijdsspanne: 2009-2010
|
Specialty of vaccinating physician who provided FluMist
|
2009-2010
|
|
Geographic Region: Northeastern
Tijdsspanne: 2009-2010
|
Geographic region of parents' residence among participants receiving FluMist
|
2009-2010
|
|
Geographic Region: North Central
Tijdsspanne: 2009-2010
|
Geographic region of parents' residence among participants receiving FluMist
|
2009-2010
|
|
Geographic Region: Southern
Tijdsspanne: 2009-2010
|
Geographic region of parents' residence among participants receiving FluMist
|
2009-2010
|
|
Geographic Region: Western
Tijdsspanne: 2009-2010
|
Geographic region of parents' residence among participants receiving FluMist
|
2009-2010
|
|
Number of Outpatient Visits: 0
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Medewerkers
Onderzoekers
- Studie directeur: Chris Ambrose, M.D., MedImmune LLC
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 oktober 2007
Primaire voltooiing (Werkelijk)
1 maart 2010
Studie voltooiing (Werkelijk)
1 maart 2010
Studieregistratiedata
Eerst ingediend
20 februari 2008
Eerst ingediend dat voldeed aan de QC-criteria
20 februari 2008
Eerst geplaatst (Schatting)
29 februari 2008
Updates van studierecords
Laatste update geplaatst (Schatting)
12 augustus 2014
Laatste update ingediend die voldeed aan QC-criteria
21 juli 2014
Laatst geverifieerd
1 juli 2014
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- MI-MA175
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