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

July 21, 2014 updated by: 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
321697

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Research Triangle, North Carolina, United States
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children < 60 months of age.

Description

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
1
Children less than 24 months of age
Drug: No Intervention
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
Drug: No Intervention
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
Drug: No Intervention
There were no interventions. No subjects were enrolled in this retrospective database study.
4
Children 24-59 months of age with immunosuppression
Drug: No Intervention
There were no interventions. No subjects were enrolled in this retrospective database study.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
FluMist Use in Participants up to 59 Months of Age
Time Frame: 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
Time Frame: 2009-2010
Specialty of vaccinating physician who provided FluMist.
2009-2010
Vaccinating Physician Specialty: General/Family Practitioner
Time Frame: 2009-2010
Specialty of vaccinating physician who provided FluMist
2009-2010
Vaccinating Physician Specialty: Other
Time Frame: 2009-2010
Specialty of vaccinating physician who provided FluMist
2009-2010
Vaccinating Physician Specialty: Unknown
Time Frame: 2009-2010
Specialty of vaccinating physician who provided FluMist
2009-2010
Geographic Region: Northeastern
Time Frame: 2009-2010
Geographic region of parents' residence among participants receiving FluMist
2009-2010
Geographic Region: North Central
Time Frame: 2009-2010
Geographic region of parents' residence among participants receiving FluMist
2009-2010
Geographic Region: Southern
Time Frame: 2009-2010
Geographic region of parents' residence among participants receiving FluMist
2009-2010
Geographic Region: Western
Time Frame: 2009-2010
Geographic region of parents' residence among participants receiving FluMist
2009-2010
Number of Outpatient Visits: 0
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
MedImmune LLC

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
RTI International

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Chris Ambrose, M.D., MedImmune LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2010

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 20, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 29, 2008

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 12, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 21, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MI-MA175

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings