A Study to Describe Pediatric Influenza Vaccine Coverage | NCT00639418

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
Participants 6 to 23 months	Pediatric influenza vaccine coverage within practicing pediatricians' offices for participants 6 to 23 months of age	Biological: Influenza vaccination
Participants 24 to 59 months	Pediatric influenza vaccine coverage within practicing pediatricians' offices for participants 24 to 59 months of age	Biological: Influenza vaccination
Participants 5 to 8 years	Pediatric influenza vaccine coverage within practicing pediatricians' offices for participants 5 to 8 years of age	Biological: Influenza vaccination
Participants 9 to 17 years	Pediatric influenza vaccine coverage within practicing pediatricians' offices for participants 9 to 17 years of age	Biological: Influenza vaccination

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Influenza vaccination	Biological	This non-interventional study prospectively captured vaccine coverage and practices of participating physician offices through use of surveys during the influenza vaccination season.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Influenza Vaccine Coverage in Participants <18 Years of Age by Age Group in Pediatric Practices	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.	Seasonal: 2007-2011

Secondary Outcomes

Measure	Description	Time Frame
Compliance With the Recommended Two-dose Regimen in Vaccinated Participants	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.	Seasonal: 2007-2011
Correlation of Office Vaccination-related Attitudes and Activities With Actual Vaccine Coverage

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Chris Ambrose, M.D.	MedImmune LLC	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Ark-La-Tex Pediatric Research		Birmingham	Alabama	35242	United States
Jordan Ridge Kids and Teens

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21445003	Result	Toback SL, Carr W, Hackell J, Bhatt P, Ryan A, Ambrose CS. Influenza vaccination of parents and guardians by US pediatricians. Hum Vaccin. 2011 Apr;7(4):436-40. doi: 10.4161/hv.7.4.14171. Epub 2011 Apr 1.
20686436	Result	Bhatt P, Block SL, Toback SL, Ambrose CS. Timing of the availability and administration of influenza vaccine through the vaccines for children program. Pediatr Infect Dis J. 2011 Feb;30(2):100-6. doi: 10.1097/INF.0b013e3181efff54.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Participants 6 to 23 Months	Pediatric influenza vaccine coverage within practicing pediatricians' offices for participants 6 to 23 months of age
FG001	Participants 24 to 59 Months

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

Arm/Group Information

ID	Title	Description
BG000	Participants 6 to 23 Months	Pediatric influenza vaccine coverage within practicing pediatricians' offices for participants 6 to 23 months of age
BG001	Participants 24 to 59 Months	Pediatric influenza vaccine coverage within practicing pediatricians' offices for participants 24 to 59 months of age
BG002	Participants 5 to 8 Years	Pediatric influenza vaccine coverage within practicing pediatricians' offices for participants 5 to 8 years of age
BG003	Participants 9 to 18 Years	Pediatric influenza vaccine coverage within practicing pediatricians' offices for participants 9 to 17 years of age
BG004	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Customized

Number of participants in each age group

Number

participants

Title

Denominators

Categories

Title	Measurements
	OG00046.5 OG00130.9 OG00230.6 OG003

Secondary

Compliance With the Recommended Two-dose Regimen in Vaccinated Participants

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.

Posted

Number

percentage of participants

Seasonal: 2007-2011

ID	Title	Description
OG000	Participants 6 to 23 Months	Pediatric influenza vaccine coverage within practicing pediatricians' offices for participants 6 to 23 months of age
OG001	Participants 24 to 59 Months	Pediatric influenza vaccine coverage within practicing pediatricians' offices for participants 24 to 59 months of age
OG002	Participants 5 to 8 Years	Pediatric influenza vaccine coverage within practicing pediatricians' offices for participants 5 to 8 years of age
OG003	Participants 9 to 18 Years	Pediatric influenza vaccine coverage within practicing pediatricians' offices for participants 9 to 17 years of age

Secondary

Correlation of Office Vaccination-related Attitudes and Activities With Actual Vaccine Coverage

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.

Posted

Number

Sites

Seasonal: 2007-2011

ID	Title	Description
OG000	Staff Attitudes: High-risk Medical Conditions	Number of sites that agreed or somewhat agreed that they strongly recommend seasonal influenza vaccination to patients 5 to 18 years of age with high-risk medical conditions
OG001	Staff Attitudes: 6 Months to 5 Year Old Patients	Number of sites that strongly recommend that patients 6 months to 5 years of age be vaccinated against influenza each year.
OG002	Staff Attitudes: 5 to 18 Year Old Patients	Number of sites that agreed or somewhat agreed that they strongly recommend that patients 5 to 18 years of age without high-risk medical conditions be vaccinated against influenza each year

Arm/Groups

ID	Title	Description
EG000	Children 6 to 23 Months	AEs were not collected in this observational study of physician vaccination practices.
EG001	Children 24 to 59 Months	AEs were not collected in this observational study of physician vaccination practices.
EG002	Children 5 to 8 Years	AEs were not collected in this observational study of physician vaccination practices.
EG003	Children 9 to 18 Years	AEs were not collected in this observational study of physician vaccination practices.

ID	Term
D014765	Viral Vaccines
D014612	Vaccines
D001688	Biological Products
D045424	Complex Mixtures