A Post Marketing Evaluation of the Effectiveness of FluMist Risk Minimization Plan in Children

A Post Marketing Evaluation of the Effectiveness of the Risk Minimization Plan For Use of FluMist Among Children Less Than 5 Years of Age

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00626808

Enrollment

321697

Registered

2008-02-29

Start date

2007-10-31

Completion date

2010-03-31

Last updated

2014-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma, Immunosuppression, Wheezing

Brief summary

This is a retrospective cohort study of children included in a large medical insurance claims database.

Detailed description

* 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

Interventions

DRUGNo Intervention

There were no interventions. No subjects were enrolled in this retrospective database study.

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* 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.

Design outcomes

Primary

Measure	Time frame	Description
FluMist Use in Participants up to 59 Months of Age	2009-2010	Among participants up to 59 months of age who received any flu vaccine, number who received FluMist
Vaccinating Physician Specialty: Pediatrician or Pediatric Specialist	2009-2010	Specialty of vaccinating physician who provided FluMist.
Vaccinating Physician Specialty: General/Family Practitioner	2009-2010	Specialty of vaccinating physician who provided FluMist
Vaccinating Physician Specialty: Other	2009-2010	Specialty of vaccinating physician who provided FluMist
Vaccinating Physician Specialty: Unknown	2009-2010	Specialty of vaccinating physician who provided FluMist
Geographic Region: Northeastern	2009-2010	Geographic region of parents' residence among participants receiving FluMist
Geographic Region: North Central	2009-2010	Geographic region of parents' residence among participants receiving FluMist
Geographic Region: Southern	2009-2010	Geographic region of parents' residence among participants receiving FluMist
Geographic Region: Western	2009-2010	Geographic region of parents' residence among participants receiving FluMist
Number of Outpatient Visits: 0	2009-2010	Among participants vaccinated with FluMist, the number who had 0 outpatient visits in the 3 months prior to vaccination
Number of Outpatient Visits: 1	2009-2010	Among participants vaccinated with FluMist, the number who had 1 outpatient visit in the 3 months prior to vaccination
Number of Outpatient Visits: 2 or More	2009-2010	Among participants vaccinated with FluMist, the number who had 2 or more outpatient visits in the 3 months prior to vaccination
Number of Days With a Respiratory Claim in 28 Days Prior to Vaccination: 0	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.
Number of Days With a Respiratory Claim in 28 Days Prior to Vaccination: 1	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.
Number of Days With a Respiratory Claim in 28 Days Prior to Vaccination: 2 or More	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.

Countries

United States

Participant flow

Recruitment details

This was a retrospective descriptive cohort study of participants up to 59 months of age included in a large medical insurance claims database. Participants up to 59 months of age were screened for vaccination with FluMist or TIV as part of routine clinical practice.

Participants by arm

Arm	Count
Participants Less Than 24 Months of Age Participants less than 24 months of age	254,464
Participants 24-59 Months of Age With Asthma Participants 24-59 months of age with a claim associated with a diagnosis of asthma	34,316
Participants 24-59 Months of Age With Wheezing Participants 24-59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing	30,011
Participants 24-59 Months of Age With Immunosuppression Participants 24-59 months of age who had claims associated with any of the following: transplantation, congenital immune deficiency, symptomatic human immunodeficiency virus, hematologic/lymphatic malignancy; immunosuppressive therapy other than systemic corticosteroids within the previous 16 weeks; systemic corticosteroids	2,906
Total	321,697

Baseline characteristics

Characteristic	Participants Less Than 24 Months of Age	Participants 24-59 Months of Age With Asthma	Participants 24-59 Months of Age With Wheezing	Participants 24-59 Months of Age With Immunosuppression	Total
Age, Customized < 24 months	254464 children	0 children	0 children	0 children	254464 children
Age, Customized >= 24 months	0 children	34316 children	30011 children	2906 children	67233 children
Sex: Female, Male Female	NA Participants	NA Participants	NA Participants	NA Participants	NA Participants
Sex: Female, Male Male	NA Participants	NA Participants	NA Participants	NA Participants	NA Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —	— / —
other Total, other adverse events	0 / 0	0 / 0	0 / 0	0 / 0
serious Total, serious adverse events	0 / 0	0 / 0	0 / 0	0 / 0

Outcome results

Primary