Study identifier:MI-MA156
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
An Observational Study to Describe Pediatric Influenza Vaccine Coverage Among Pediatricians in the United States
Healthy
Phase 4
Yes
-
All
147494
Observational
6 Months +
Allocation: Non-randomized
Endpoint Classification: -
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: -
Verified 01 Sept 2014 by MedImmune, LLC
MedImmune, LLC
-
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.
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.
Location
Location
Webster, TX, United States, 77598
Location
PUEBLO, CO, United States, 81003
Location
BROWNSVILLE, TX, United States, 78526
Location
Lock Haven, PA, United States, 17745
Location
Wasilla, AR, United States, 99654
Location
Rockingham, NC, United States, 28379
Location
Las Vegas, NV, United States, 89128
Location
Henderson, NC, United States, 28739
Arms | Assigned Interventions |
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Participants 6 to 23 months Pediatric influenza vaccine coverage within practicing pediatricians’ offices for participants 6 to 23 months of age | Biological/Vaccine: 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/Vaccine: 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/Vaccine: 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/Vaccine: 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. |
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
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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. |
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
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While a total of 147494 children were vaccinated in participating physicians' offices, no subjects were actually treated in this observational study. |
Description | |
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Participants 6 to 23 months | Pediatric influenza vaccine coverage within practicing pediatricians’ offices for participants 6 to 23 months of age |
Participants 24 to 59 months | Pediatric influenza vaccine coverage within practicing pediatricians’ offices for participants 24 to 59 months of age |
Participants 5 to 8 years | Pediatric influenza vaccine coverage within practicing pediatricians’ offices for participants 5 to 8 years of age |
Participants 9 to 18 years | Pediatric influenza vaccine coverage within practicing pediatricians’ offices for participants 9 to 17 years of age |
Participants 6 to 23 months | Participants 24 to 59 months | Participants 5 to 8 years | Participants 9 to 18 years | |
---|---|---|---|---|
STARTED | 28101 | 35967 | 36496 | 46930 |
COMPLETED | 28101 | 35967 | 36496 | 46930 |
NOT COMPLETED | 0 | 0 | 0 | 0 |
Description | |
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Participants 6 to 23 months | Pediatric influenza vaccine coverage within practicing pediatricians’ offices for participants 6 to 23 months of age |
Participants 24 to 59 months | Pediatric influenza vaccine coverage within practicing pediatricians’ offices for participants 24 to 59 months of age |
Participants 5 to 8 years | Pediatric influenza vaccine coverage within practicing pediatricians’ offices for participants 5 to 8 years of age |
Participants 9 to 18 years | Pediatric influenza vaccine coverage within practicing pediatricians’ offices for participants 9 to 17 years of age |
Participants 6 to 23 months | Participants 24 to 59 months | Participants 5 to 8 years | Participants 9 to 18 years | Total | |
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Number of Participants
[units: Participants] |
28101 | 35967 | 36496 | 46930 | 147494 |
Gender, Male/Female
[1] [units: participants] |
|||||
Female | na | na | na | na | NaN |
Male | na | na | na | na | NaN |
Age, Customized
[2] [units: participants] |
28101 | 35967 | 36496 | 46930 | 147494 |
Measure Type | Primary |
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Measure Name | Influenza vaccine coverage in participants <18 years of age by age group in pediatric practices |
Measure Description | 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 |
Safety Issue? | No |
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
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Description | |
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Participants 6 to 23 months | Pediatric influenza vaccine coverage within practicing pediatricians’ offices for participants 6 to 23 months of age |
Participants 24 to 59 months | Pediatric influenza vaccine coverage within practicing pediatricians’ offices for participants 24 to 59 months of age |
Participants 5 to 8 years | Pediatric influenza vaccine coverage within practicing pediatricians’ offices for participants 5 to 8 years of age |
Participants 9 to 18 years | Pediatric influenza vaccine coverage within practicing pediatricians’ offices for participants 9 to 17 years of age |
Participants 6 to 23 months | Participants 24 to 59 months | Participants 5 to 8 years | Participants 9 to 18 years | |
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Number of
Participants Analyzed [units:participants] |
28101 | 35967 | 36496 | 46930 |
Influenza vaccine coverage in participants <18 years of age by age group in pediatric practices [units: percentage of participants] |
46.5 | 30.9 | 30.6 | 19.4 |
Measure Type | Secondary |
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Measure Name | Compliance with the recommended two-dose regimen in vaccinated participants |
Measure Description | 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 |
Safety Issue? | No |
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
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Description | |
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Participants 6 to 23 months | Pediatric influenza vaccine coverage within practicing pediatricians’ offices for participants 6 to 23 months of age |
Participants 24 to 59 months | Pediatric influenza vaccine coverage within practicing pediatricians’ offices for participants 24 to 59 months of age |
Participants 5 to 8 years | Pediatric influenza vaccine coverage within practicing pediatricians’ offices for participants 5 to 8 years of age |
Participants 9 to 18 years | Pediatric influenza vaccine coverage within practicing pediatricians’ offices for participants 9 to 17 years of age |
Participants 6 to 23 months | Participants 24 to 59 months | Participants 5 to 8 years | Participants 9 to 18 years | |
---|---|---|---|---|
Number of
Participants Analyzed [units:participants] |
28101 | 35967 | 36496 | 46930 |
Compliance with the recommended two-dose regimen in vaccinated participants [units: percentage of participants] |
67.5 | 42.7 | 40.8 | na [1] |
[1] | Compliance was not calculated for this age group as 2 doses are not required. |
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Measure Type | Secondary |
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Measure Name | Correlation of office vaccination-related attitudes and activities with actual vaccine coverage |
Measure Description | 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 |
Safety Issue? | No |
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
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Description | |
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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 |
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. |
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 |
Staff attitudes: number of doses | Number of sites that agreed or somewhat agreed that they strongly recommend that previously unvaccinated patients less than 9 years of age receive 2 doses of influenza vaccine |
Staff attitudes: high-risk medical conditions | Staff attitudes: 6 months to 5 year old patients | Staff attitudes: 5 to 18 year old patients | Staff attitudes: number of doses | |
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Number of
Participants Analyzed [units:participants] |
118 | 118 | 118 | 118 |
Correlation of office vaccination-related attitudes and activities with actual vaccine coverage [units: Sites] |
117 | 118 | 118 | 117 |
Time Frame | No text entered. |
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Additional Description | No text entered. |
Description | |
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Children 6 to 23 months | AEs were not collected in this observational study of physician vaccination practices. |
Children 24 to 59 months | AEs were not collected in this observational study of physician vaccination practices. |
Children 5 to 8 years | AEs were not collected in this observational study of physician vaccination practices. |
Children 9 to 18 years | AEs were not collected in this observational study of physician vaccination practices. |
Children 6 to 23 months | Children 24 to 59 months | Children 5 to 8 years | Children 9 to 18 years | |
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Total, serious adverse events | ||||
# participants affected / at risk | 0/0 | 0/0 | 0/0 | 0/0 |
Time Frame | No text entered. |
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Additional Description | No text entered. |
Threshold above which other adverse events are reported | 0% |
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Description | |
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Children 6 to 23 months | AEs were not collected in this observational study of physician vaccination practices. |
Children 24 to 59 months | AEs were not collected in this observational study of physician vaccination practices. |
Children 5 to 8 years | AEs were not collected in this observational study of physician vaccination practices. |
Children 9 to 18 years | AEs were not collected in this observational study of physician vaccination practices. |
Children 6 to 23 months | Children 24 to 59 months | Children 5 to 8 years | Children 9 to 18 years | |
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Total, other (not including serious) adverse events | ||||
# participants affected / at risk | 0/0 | 0/0 | 0/0 | 0/0 |
Principal Investigators are NOT employed by the organization sponsoring the study. | ||||||
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. | ||||||
The agreement is:
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
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No text entered. |
Name/Title: | Chris Ambrose |
Organization: | MedImmune LLC |
Phone | 301-398-0000 |
E-mail: | [email protected] |
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