A Study to Describe Pediatric Influenza Vaccine Coverage - Full Text View

Sponsored by:	MedImmune LLC
Information provided by:	MedImmune LLC
ClinicalTrials.gov Identifier:	NCT00639418

Purpose

The purpose of this study is to describe influenza vaccine coverage in children less than 18 years of age and to examine correlations between in-office influenza vaccine coverage various tactics to increase vaccine coverage.

Condition
Healthy

MedlinePlus related topics: Flu

Drug Information available for: Influenza Vaccines Fluvirin

U.S. FDA Resources

Study Type:	Observational
Study Design:	Prospective
Official Title:	An Observational Study to Describe Pediatric Influenza Vaccine Coverage Among Pediatricians in the U.S.

Further study details as provided by MedImmune LLC:

Primary Outcome Measures:

Influenza vaccine coverage in children <18 years of age by age group [ Time Frame: December 2008 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Compliance with the recommended two-dose regimen in vaccinated children [ Time Frame: TBD ] [ Designated as safety issue: No ]
Correlation of office vaccination-related attitudes and activities with actual vaccine coverage [ Time Frame: TBD ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	0
Study Start Date:	September 2007
Estimated Study Completion Date:	June 2012
Estimated Primary Completion Date:	March 2012 (Final data collection date for primary outcome measure)

Groups/Cohorts
1 Children 6 to 23 months
2 Children 24 to 59 months
3 Children 5 to 8 years
4 Children 9 to 17 years

Detailed Description:

To describe influenza vaccine coverage in children less than 18 years of age in practicing pediatricians' 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 to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Fifty to 100 pediatrician offices will be selected to participate Children 6 to 23 months Children 24 to 59 months Children 5 to 8 years Children 9 to 17 years

Criteria

Inclusion Criteria:

6 months to 17 years of age
Males and females

Exclusion Criteria:

None

Contacts and Locations

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

Sponsors and Collaborators

MedImmune LLC

Investigators

Study Director:

Chris Ambrose, M.D.

MedImmune LLC

More Information

Responsible Party:	MedImmune ( Chris Ambrose M.D. )
Study ID Numbers:	MI-MA156
Study First Received:	March 4, 2008
Last Updated:	September 5, 2008
ClinicalTrials.gov Identifier:	NCT00639418
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Influenza, Human
Healthy

ClinicalTrials.gov processed this record on January 16, 2009