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

NCT00626808 | Completed Results

• 1 other identifier: MI-MA175
• Study Type: observational
• Target: 321,697
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Asthma; Wheezing; Immunosuppression

Outcome Measures

Primary Outcomes (15)

• FluMist Use in Participants up to 59 Months of Age

  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

  Specialty of vaccinating physician who provided FluMist.

  2009-2010

• Vaccinating Physician Specialty: General/Family Practitioner

  Specialty of vaccinating physician who provided FluMist

  2009-2010

• Vaccinating Physician Specialty: Other

  Specialty of vaccinating physician who provided FluMist

  2009-2010

• Vaccinating Physician Specialty: Unknown

  Specialty of vaccinating physician who provided FluMist

  2009-2010

• Geographic Region: Northeastern

  Geographic region of parents' residence among participants receiving FluMist

  2009-2010

• Geographic Region: North Central

  Geographic region of parents' residence among participants receiving FluMist

  2009-2010

• Geographic Region: Southern

  Geographic region of parents' residence among participants receiving FluMist

  2009-2010

• Geographic Region: Western

  Geographic region of parents' residence among participants receiving FluMist

  2009-2010

• Number of Outpatient Visits: 0

  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

  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

  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

  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

  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

  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

Study Arms (4)

1

Children less than 24 months of age

Drug: No Intervention

2

Children 24 to 59 months of age with a claim associated with a diagnosis of asthma

Drug: No Intervention

3

Children 24 to 59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing

Drug: No Intervention

4

Children 24-59 months of age with immunosuppression

Drug: No Intervention

Interventions

No Intervention DRUG

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

1; 2; 3; 4

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Children \< 60 months of age.

* 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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• MedImmune LLC: lead
• RTI International: collaborator

Study Sites (1)

Research Site

Research Triangle Park, North Carolina, United States

Location

MeSH Terms

Conditions

Asthma; Respiratory Sounds

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Chris Ambrose
• Organization: MedImmune, LLC

ambrosec@medimmune.com

301-398-0000

Study Officials

• Chris Ambrose, M.D.

  MedImmune LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2008
• First Posted: February 29, 2008
• Study Start: October 1, 2007
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: August 12, 2014
• Results First Posted: August 12, 2014

Record last verified: 2014-07

Locations

US (1)