A Study to Describe Pediatric Influenza Vaccine Coverage

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT00639418
First received: March 4, 2008
Last updated: September 12, 2014
Last verified: September 2014
  Purpose

The purpose of this study is to describe flu vaccine coverage in children under 18 years of age and to examine correlations between in-office flu vaccine coverage and the use of various tactics to increase vaccine coverage.


Condition Intervention Phase
Healthy
Biological: Influenza vaccination
Phase 4

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: An Observational Study to Describe Pediatric Influenza Vaccine Coverage Among Pediatricians in the United States

Resource links provided by NLM:


Further study details as provided by MedImmune LLC:

Primary Outcome Measures:
  • Influenza Vaccine Coverage in Participants <18 Years of Age by Age Group in Pediatric Practices [ Time Frame: Seasonal: 2007-2011 ] [ Designated as safety issue: No ]
    Vaccine coverage was calculated from the number of participants vaccinated in each group, divided by the total number of participants under the practice's care in that specific age group.


Secondary Outcome Measures:
  • Compliance With the Recommended Two-dose Regimen in Vaccinated Participants [ Time Frame: Seasonal: 2007-2011 ] [ Designated as safety issue: No ]
    Compliance was calculated from the total number of participants receiving 2 doses divided by the total number of participants identified as requiring a second dose.

  • Correlation of Office Vaccination-related Attitudes and Activities With Actual Vaccine Coverage [ Time Frame: Seasonal: 2007-2011 ] [ Designated as safety issue: No ]
    Correlation of office attitudes related to influenza vaccination and actual vaccine coverage was explored. Sites were asked to indicate level of agreement with the following recommendations: vaccinating children with high-risk medical conditions, patients 6 months to 5 years of age should be vaccinated against influenza each year, patients 5 to 18 years of age without high-risk medical conditions should be vaccinated against influenza each year, and previously unvaccinated patients less than 9 years of age receive 2 doses of vaccine.


Enrollment: 147494
Study Start Date: August 2007
Study Completion Date: June 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Participants 6 to 23 months
Pediatric influenza vaccine coverage within practicing pediatricians' offices for participants 6 to 23 months of age
Biological: Influenza vaccination
This non-interventional study prospectively captured vaccine coverage and practices of participating physician offices through use of surveys during the influenza vaccination season.
Participants 24 to 59 months
Pediatric influenza vaccine coverage within practicing pediatricians' offices for participants 24 to 59 months of age
Biological: Influenza vaccination
This non-interventional study prospectively captured vaccine coverage and practices of participating physician offices through use of surveys during the influenza vaccination season.
Participants 5 to 8 years
Pediatric influenza vaccine coverage within practicing pediatricians' offices for participants 5 to 8 years of age
Biological: Influenza vaccination
This non-interventional study prospectively captured vaccine coverage and practices of participating physician offices through use of surveys during the influenza vaccination season.
Participants 9 to 17 years
Pediatric influenza vaccine coverage within practicing pediatricians' offices for participants 9 to 17 years of age
Biological: Influenza vaccination
This non-interventional study prospectively captured vaccine coverage and practices of participating physician offices through use of surveys during the influenza vaccination season.

Detailed Description:

To describe influenza vaccine coverage in children less than 18 years of age in practicing pediatricians' offices and family medicine physicians' offices and to examine correlations between in-office influenza vaccine coverage and the use of various tactics to increase vaccine coverage.

  Eligibility

Ages Eligible for Study:   6 Months and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Physician offices that were selected to participate in the study

Criteria

Sites selected to participate were required to be able to accurately identify the number of patients under their care by age group and provide influenza vaccine at their location.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00639418

  Show 187 Study Locations
Sponsors and Collaborators
MedImmune LLC
Investigators
Study Director: Chris Ambrose, M.D. MedImmune LLC