N/A N=321,697

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

Asthma · Wheezing · Immunosuppression

Bottom Line

View on ClinicalTrials.gov: NCT00626808 ↗

Enrolled (actual)

321,697

Serious AEs

—

Results posted

Aug 2014

Primary outcome: Primary: FluMist Use in Participants up to 59 Months of Age — 775; 3457; 5821; 361 Number of participants

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: No Intervention (Drug)
Age: Pediatric, Adult, Older Adult
Sex: All
Sponsor: MedImmune LLC
Primary completion: Mar 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY FluMist Use in Participants up to 59 Months of Age	775; 3457; 5821; 361	—
PRIMARY Vaccinating Physician Specialty: Pediatrician or Pediatric Specialist	553; 2782; 4704; 291	—
PRIMARY Vaccinating Physician Specialty: General/Family Practitioner	60; 140; 267; 13	—
PRIMARY Vaccinating Physician Specialty: Other	103; 346; 581; 37	—
PRIMARY Vaccinating Physician Specialty: Unknown	59; 189; 269; 20	—
PRIMARY Geographic Region: Northeastern	64; 353; 392; 20	—
PRIMARY Geographic Region: North Central	214; 755; 1635; 101	—
PRIMARY Geographic Region: Southern	364; 1937; 3127; 204	—
PRIMARY Geographic Region: Western	132; 404; 662; 36	—
PRIMARY Number of Outpatient Visits: 0	147; 910; 1994; 61	—
PRIMARY Number of Outpatient Visits: 1	246; 987; 1724; 99	—
PRIMARY Number of Outpatient Visits: 2 or More	382; 1560; 2103; 201	—
PRIMARY Number of Days With a Respiratory Claim in 28 Days Prior to Vaccination: 0	677; 2778; 5049; 245	—
PRIMARY Number of Days With a Respiratory Claim in 28 Days Prior to Vaccination: 1	95; 670; 769; 114	—
PRIMARY Number of Days With a Respiratory Claim in 28 Days Prior to Vaccination: 2 or More	3; 9; 3; 2	—

Summary

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

Eligibility 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00626808). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.