Healthy
Conditions
Brief summary
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.
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.
Interventions
BIOLOGICALInfluenza vaccination
This non-interventional study prospectively captured vaccine coverage and practices of participating physician offices through use of surveys during the influenza vaccination season.
Sponsors
MedImmune LLC
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
6 Months to No maximum
Healthy volunteers
Yes
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Influenza Vaccine Coverage in Participants <18 Years of Age by Age Group in Pediatric Practices | Seasonal: 2007-2011 | 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
| Measure | Time frame | Description |
|---|---|---|
| Compliance With the Recommended Two-dose Regimen in Vaccinated Participants | Seasonal: 2007-2011 | 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 | Seasonal: 2007-2011 | 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. |
Countries
United States
Participant flow
Recruitment details
This study of 118 physician offices in the USA identified the number of patients per practice by age group. A baseline survey and semi-monthly surveys of number of influenza vaccination doses given, staff attitudes toward influenza vaccination, and activities to increase influenza vaccination coverage were completed.
Pre-assignment details
While a total of 147494 children were vaccinated in participating physicians' offices, no subjects were actually treated in this observational study.
Participants by arm
| Arm | Count |
|---|---|
| Participants 6 to 23 Months Pediatric influenza vaccine coverage within practicing pediatricians' offices for participants 6 to 23 months of age | 28,101 |
| Participants 24 to 59 Months Pediatric influenza vaccine coverage within practicing pediatricians' offices for participants 24 to 59 months of age | 35,967 |
| Participants 5 to 8 Years Pediatric influenza vaccine coverage within practicing pediatricians' offices for participants 5 to 8 years of age | 36,496 |
| Participants 9 to 18 Years Pediatric influenza vaccine coverage within practicing pediatricians' offices for participants 9 to 17 years of age | 46,930 |
| Total | 147,494 |
Baseline characteristics
| Characteristic | Participants 6 to 23 Months | Participants 24 to 59 Months | Participants 5 to 8 Years | Participants 9 to 18 Years | Total |
|---|---|---|---|---|---|
| Age, Customized | 28101 participants | 35967 participants | 36496 participants | 46930 participants | 147494 participants |
| Sex: Female, Male Female | NA Participants | NA Participants | NA Participants | NA Participants | NA Participants |
| Sex: Female, Male Male | NA Participants | NA Participants | NA Participants | NA Participants | NA Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
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.
Time frame: Seasonal: 2007-2011
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Participants 6 to 23 Months | Influenza Vaccine Coverage in Participants <18 Years of Age by Age Group in Pediatric Practices | 46.5 percentage of participants |
| Participants 24 to 59 Months | Influenza Vaccine Coverage in Participants <18 Years of Age by Age Group in Pediatric Practices | 30.9 percentage of participants |
| Participants 5 to 8 Years | Influenza Vaccine Coverage in Participants <18 Years of Age by Age Group in Pediatric Practices | 30.6 percentage of participants |
| Participants 9 to 18 Years | Influenza Vaccine Coverage in Participants <18 Years of Age by Age Group in Pediatric Practices | 19.4 percentage of participants |
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.
Time frame: Seasonal: 2007-2011
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Participants 6 to 23 Months | Compliance With the Recommended Two-dose Regimen in Vaccinated Participants | 67.5 percentage of participants |
| Participants 24 to 59 Months | Compliance With the Recommended Two-dose Regimen in Vaccinated Participants | 42.7 percentage of participants |
| Participants 5 to 8 Years | Compliance With the Recommended Two-dose Regimen in Vaccinated Participants | 40.8 percentage of participants |
| Participants 9 to 18 Years | Compliance With the Recommended Two-dose Regimen in Vaccinated Participants | NA percentage of participants |
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.
Time frame: Seasonal: 2007-2011
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Participants 6 to 23 Months | Correlation of Office Vaccination-related Attitudes and Activities With Actual Vaccine Coverage | 117 Sites |
| Participants 24 to 59 Months | Correlation of Office Vaccination-related Attitudes and Activities With Actual Vaccine Coverage | 118 Sites |
| Participants 5 to 8 Years | Correlation of Office Vaccination-related Attitudes and Activities With Actual Vaccine Coverage | 118 Sites |
| Participants 9 to 18 Years | Correlation of Office Vaccination-related Attitudes and Activities With Actual Vaccine Coverage | 117 Sites |