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kzNJdSnkXHe%2FW9pk7hECC%2BwL93HtqZoHMhhQFTXb15o5kBPRqpoKMYKle3oENsCgSj17p6aTD3gyYNEAhFrk4AnaHTn0kRFHH7dlMdIwGDIdC5YsdhoIP14dLI1b2D70lykG2HbUWNfpakw%2F9%2FxngpaHGqJ7E3sLaXwBMAfYo7i0T4TpG8mit82Njb5gTpBtI5ABFrHAri9BbKAh2pBnjtWL93xeFg2DlvO5JPMqTCXBFrT4xf0ikKOlLqDNtxGOhIdfnsmvLvKD9nOugYNsWrYybQkTwy3Y7XVGHQPHL4aPO6DDqGOh6h4S5uqxn7YQuiuQC0cYf5iNS59WuBjlU3JzJg%2Fk7oxGsMBvedzM%2Bx%2BjM33VVJJyrWBi64XxP6lmX5qmXaft9OCx7I6ILOFTsOJ57ilsXY3PwhZ8GxWV%2FdQr0ykoxPFSdnc0BNF%2BQU3Qx0OhHO8vDExgZPUBS4TKe5BDoXAEdV2c%2FkdFm8cwCdE2kFPb48FV3ZRFKKI9BSIUjtOlwidg%2FQ6QDOmsBoJe8pKqVXf1aTTsJ2HAE6UhoJu5%2B9k%2BYWoKOoXdM8Oso6TKFFB3CwDwDw4A8A9SEQ0wvC9dZArLUWOOo1AfDDIehdWwye5PanQ%2BkKryMNdKTHAHrdiGFV3gYYitdw9GIeRclfPbR9a9CxKqxZ%2BSyCGaQtwQQQEYVNzZxWA3o5dB6TeL%2FfEHRMl7c3pgA%2FwShOz5S4GIX30H7I6zMLdE5KOKOhCFCzgBNcdfyklPK3yLrsQGckNsdq3AuZjwxKe8c4RQ6u2TuAjpbv5F7b2k7uUBClUZBr2I4j6ai4vIeN5sbaTLfpNHpJWofjihzQ0VzmQ%2B54gw7S8B0yL7S5quEII%2FvFuKyv14SZZxbpV9lrIeCRoCOjTodPVkMXn8Xcbp7XHUBHnr5hdUc5zSz9WcvAn7EphpNzg8x3K9CR%2FDh0IjvAIzd5eB2DwIvXQuEXRlrLkE3HOKh6JNgSlJkLH141cuXjW5Jkftka4i5%2Bepf38UMp5Q2PZyToDMXmdKQdydyXFpT6iUQ%2B3wF05GnmGoPbSaa5rA90MVycs%2Bh3%2BVAJbrjwCd9oY7nMZa2gUzZCY8xwI3Oj%2FqW2DbU7BByGWhb6lu2NUe8k2ZUi7nsPR%2Bj3z0spf%2FRe3kBHIdppPVfJpzlITCwbt0aqsDXmdE%2B%2BO4COBGZ3g3VOoUgS4rC02TkMwGC8%2FhFeRTmOQ0kRRTWjUhWH8rG3sum0NZcHWOhub0rEtQJMDVPCSNuwCUHyWmlnSCuudNq5zncUdLQof2%2F%2Fz%2Fw9VEsHHXLQ6dbNGRmdoWKtC9D0TizYUO6VYdM5LIwCOp6HaAcinstcibwGaUxbQxu3rMFC5JSgczkex1sn5UBQC1HxdhTayxoyN1GvOhKit6bS0InxIrdql1xrrKVX9At8ixQKUj22ioqKzcyrLogQEbkXiPQh1YxJOlJd9Fhh1u%2FwyIGP3etvqMMVdHogcXZkSmLipo8bl8QD9MAUO5diOwm0FHxVvzdqpCCMG8wC3RS4skVojgYHdoLWaPy8MhzFHhEZsTC8bskmJd0oGI76lTVqtFPxEPDVqf8swfJmoNP4U3r98N9qdKwR8m%2Fd3wSe4LVx%2BDrtNlKjBeYJe5ssErc6Ejp3kIOvSZokPgTgEC%2BAZ2Bj4bzhSkniYLgn6ICPEX%2B2xmmNYgSBjtQHL8ctKJZ0npVsLXZ0%2FIiGVK8y7dxCSm13ayR7ko6h5kXGjcA2bBRew4WXcdBqHUfajbwjQadHf6q0yI2GvI8D2N9SvWInuQY8%2BJk2LM9l4uPtFilzJFG0w0vPSvvHQZIxDtTeGq2SZivFOhQ4KkBH2qgifBF9B2MEaAJokI5kFnyLNEigc4jNQWJcpAHrHaNolWR%2BMBKSIKOh4m7hoIAV%2FzLoNOCxYockSTa3pCJR8uTGu4FOYCNry2rS%2Fh6gM0hzGn8oRqYjTfW2gNm2obZpbW11aZTDcshTF4yEjm5pSrrG35BmTqU7WJ0Vdicxf%2Bd0gR6BvgAVJLvRs6tP3BabClRDFeF3DdE3VHw7jLIsZBvqFNe90RakC34FDewt2wnWqwMkiciM4dsVNe0dGvOurzbfXX%2FNkAvRHOPkAWtRBom8t5XTNOZgpaCQFAF6QbpUT7imAvPiYId17g2ySQfbens3irBSsbwOM76n1BOznK0zDuJFuZ6cF1dVyVMr2nri4Ab%2Fk9TIU2N2bbA8PurrK9w7FVlcdoigH%2FRJe8n7HHwq0zFwEF6SZLxO3cLsXgP5%2B%2BtFARazAXX4psw3g3JsvDDWTT2RedvtIr%2BHpwcDIEofouqARBtSn59sff8H57piU0311KcAAAAASUVORK5CYII%3D%22%2F%3E%0A%3C%2Fdefs%3E%0A%3C%2Fsvg%3E%0A)
A Post Marketing Evaluation of the Effectiveness of FluMist Risk Minimization Plan in Children
Study identifier:MI-MA175
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Post Marketing Evaluation of the Effectiveness of the Risk Minimization Plan For Use of FluMist Among Children Less than 5 Years of Age
Medical condition
asthma, immunosuppression
Phase
Phase 4
Healthy volunteers
No
Study drug
No Intervention
Sex
All
Actual Enrollment
321697
Study type
Observational
Age
N/A
Date
Study Start Date: 01 Oct 2007
Primary Completion Date: 01 Mar 2010
Study Completion Date: 01 Mar 2010
Study design
Allocation: Non-randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: -
Verification:
Verified 01 Jul 2014 by MedImmune, LLC
Sponsors
MedImmune, LLC
Collaborators
RTI International
Inclusion and exclusion criteria
Location
Research Site
Research Triangle, NC, United States
| Arms | Assigned Interventions |
|---|---|
| 1 Children less than 24 months of age | Drug: No Intervention There were no interventions. No subjects were enrolled in this retrospective database study. |
| 2 Children 24 to 59 months of age with a claim associated with a diagnosis of asthma | Drug: No Intervention There were no interventions. No subjects were enrolled in this retrospective database study. |
| 3 Children 24 to 59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing | Drug: No Intervention There were no interventions. No subjects were enrolled in this retrospective database study. |
| 4 Children 24-59 months of age with immunosuppression | Drug: No Intervention There were no interventions. No subjects were enrolled in this retrospective database study. |
Participant Flow
Recruitment Details
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
|---|
| This was a retrospective descriptive cohort study of participants up to 59 months of age included in a large medical insurance claims database. Participants up to 59 months of age were screened for vaccination with FluMist or TIV as part of routine clinical practice. |
Pre-Assignment Details
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
|---|
| Not applicable. |
Reporting Groups
| Description | |
|---|---|
| Participants less than 24 months of age | Participants less than 24 months of age |
| Participants 24-59 months of age with asthma | Participants 24-59 months of age with a claim associated with a diagnosis of asthma |
| Participants 24-59 months of age with wheezing | Participants 24-59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing |
| Participants 24-59 months of age with immunosuppression | Participants 24-59 months of age who had claims associated with any of the following: transplantation, congenital immune deficiency, symptomatic human immunodeficiency virus, hematologic/lymphatic malignancy; immunosuppressive therapy other than systemic corticosteroids within the previous 16 weeks; systemic corticosteroids |
Participant Flow: Overall Study
| Participants less than 24 months of age | Participants 24-59 months of age with asthma | Participants 24-59 months of age with wheezing | Participants 24-59 months of age with immunosuppression | |
|---|---|---|---|---|
| STARTED | 254464 | 34316 | 30011 | 2906 |
| COMPLETED | 254464 | 34316 | 30011 | 2906 |
| NOT COMPLETED | 0 | 0 | 0 | 0 |
Baseline Characteristics
Analysis Population Description -- Explanation of how the number of participants for analysis was determined.
Reporting Groups
| Description | |
|---|---|
| Participants less than 24 months of age | Participants less than 24 months of age |
| Participants 24-59 months of age with asthma | Participants 24-59 months of age with a claim associated with a diagnosis of asthma |
| Participants 24-59 months of age with wheezing | Participants 24-59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing |
| Participants 24-59 months of age with immunosuppression | Participants 24-59 months of age who had claims associated with any of the following: transplantation, congenital immune deficiency, symptomatic human immunodeficiency virus, hematologic/lymphatic malignancy; immunosuppressive therapy other than systemic corticosteroids within the previous 16 weeks; systemic corticosteroids |
Baseline Measures
| Participants less than 24 months of age | Participants 24-59 months of age with asthma | Participants 24-59 months of age with wheezing | Participants 24-59 months of age with immunosuppression | Total | |
|---|---|---|---|---|---|
|
Number of Participants
[units: Participants] |
254464 | 34316 | 30011 | 2906 | 321697 |
| Age, Customized [units: children] |
|||||
| < 24 months | 254464 | 0 | 0 | 0 | 254464 |
| >= 24 months | 0 | 34316 | 30011 | 2906 | 67233 |
| Gender, Male/Female
[1] [units: participants] |
|||||
| Female | na | na | na | na | NaN |
| Male | na | na | na | na | NaN |
Outcome Measures
1. Primary Outcome Measure: FluMist use in participants up to 59 months of age [ Time Frame: 2009-2010 ]
| Measure Type | Primary |
|---|---|
| Measure Name | FluMist use in participants up to 59 months of age |
| Measure Description | Among participants up to 59 months of age who received any flu vaccine, number who received FluMist |
| Time Frame | 2009-2010 |
| Safety Issue? | Yes |
Population Description
| 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. |
|---|
| General population of participants aged < 24 months, participants 24-59 months with asthma, participants 24-59 months with wheeing, and participants 24-59 months with immunosuppression. |
Reporting Groups
| Description | |
|---|---|
| Participants less than 24 months of age | Participants less than 24 months of age |
| Participants 24-59 months of age with asthma | Participants 24-59 months of age with a claim associated with a diagnosis of asthma |
| Participants 24-59 months of age with wheezing | Participants 24-59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing |
| Participants 24-59 months of age with immunosuppression | Participants 24-59 months of age who had claims associated with any of the following: transplantation, congenital immune deficiency, symptomatic human immunodeficiency virus, hematologic/lymphatic malignancy; immunosuppressive therapy other than systemic corticosteroids within the previous 16 weeks; systemic corticosteroids |
Measured Values
| Participants less than 24 months of age | Participants 24-59 months of age with asthma | Participants 24-59 months of age with wheezing | Participants 24-59 months of age with immunosuppression | |
|---|---|---|---|---|
|
Number of
Participants Analyzed [units:participants] |
254464 | 34316 | 30011 | 2906 |
| FluMist use in participants up to 59 months of age [units: Number of participants] |
775 | 3457 | 5821 | 361 |
No statistical analysis provided for FluMist use in participants up to 59 months of age
2. Primary Outcome Measure: Vaccinating physician specialty: pediatrician or pediatric specialist [ Time Frame: 2009-2010 ]
| Measure Type | Primary |
|---|---|
| Measure Name | Vaccinating physician specialty: pediatrician or pediatric specialist |
| Measure Description | Specialty of vaccinating physician who provided FluMist. |
| Time Frame | 2009-2010 |
| Safety Issue? | No |
Population Description
| 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. |
|---|
| General population of participants aged < 24 months, participants 24-59 months with asthma, participants 24-59 months with wheeing, and participants 24-59 months with immunosuppression. |
Reporting Groups
| Description | |
|---|---|
| Participants less than 24 months of age | Participants less than 24 months of age |
| Participants 24-59 months of age with asthma | Participants 24-59 months of age with a claim associated with a diagnosis of asthma |
| Participants 24-59 months of age with wheezing | Participants 24-59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing |
| Participants 24-59 months of age with immunosuppression | Participants 24-59 months of age who had claims associated with any of the following: transplantation, congenital immune deficiency, symptomatic human immunodeficiency virus, hematologic/lymphatic malignancy; immunosuppressive therapy other than systemic corticosteroids within the previous 16 weeks; systemic corticosteroids |
Measured Values
| Participants less than 24 months of age | Participants 24-59 months of age with asthma | Participants 24-59 months of age with wheezing | Participants 24-59 months of age with immunosuppression | |
|---|---|---|---|---|
|
Number of
Participants Analyzed [units:participants] |
775 | 3457 | 5821 | 361 |
| Vaccinating physician specialty: pediatrician or pediatric specialist [units: Number of physicians] |
553 | 2782 | 4704 | 291 |
No statistical analysis provided for Vaccinating physician specialty: pediatrician or pediatric specialist
3. Primary Outcome Measure: Vaccinating physician specialty: General/Family practitioner [ Time Frame: 2009-2010 ]
| Measure Type | Primary |
|---|---|
| Measure Name | Vaccinating physician specialty: General/Family practitioner |
| Measure Description | Specialty of vaccinating physician who provided FluMist |
| Time Frame | 2009-2010 |
| Safety Issue? | No |
Population Description
| 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. |
|---|
| General population of participants aged < 24 months, participants 24-59 months with asthma, participants 24-59 months with wheeing, and participants 24-59 months with immunosuppression. |
Reporting Groups
| Description | |
|---|---|
| Participants less than 24 months of age | Participants less than 24 months of age |
| Participants 24-59 months of age with asthma | Participants 24-59 months of age with a claim associated with a diagnosis of asthma |
| Participants 24-59 months of age with wheezing | Participants 24-59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing |
| Participants 24-59 months of age with immunosuppression | Participants 24-59 months of age who had claims associated with any of the following: transplantation, congenital immune deficiency, symptomatic human immunodeficiency virus, hematologic/lymphatic malignancy; immunosuppressive therapy other than systemic corticosteroids within the previous 16 weeks; systemic corticosteroids |
Measured Values
| Participants less than 24 months of age | Participants 24-59 months of age with asthma | Participants 24-59 months of age with wheezing | Participants 24-59 months of age with immunosuppression | |
|---|---|---|---|---|
|
Number of
Participants Analyzed [units:participants] |
775 | 3457 | 5821 | 361 |
| Vaccinating physician specialty: General/Family practitioner [units: Number of physicians] |
60 | 140 | 267 | 13 |
No statistical analysis provided for Vaccinating physician specialty: General/Family practitioner
4. Primary Outcome Measure: Vaccinating physician specialty: Other [ Time Frame: 2009-2010 ]
| Measure Type | Primary |
|---|---|
| Measure Name | Vaccinating physician specialty: Other |
| Measure Description | Specialty of vaccinating physician who provided FluMist |
| Time Frame | 2009-2010 |
| Safety Issue? | No |
Population Description
| 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. |
|---|
| General population of participants aged < 24 months, participants 24-59 months with asthma, participants 24-59 months with wheeing, and participants 24-59 months with immunosuppression. |
Reporting Groups
| Description | |
|---|---|
| Participants less than 24 months of age | Participants less than 24 months of age |
| Participants 24-59 months of age with asthma | Participants 24-59 months of age with a claim associated with a diagnosis of asthma |
| Participants 24-59 months of age with wheezing | Participants 24-59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing |
| Participants 24-59 months of age with immunosuppression | Participants 24-59 months of age who had claims associated with any of the following: transplantation, congenital immune deficiency, symptomatic human immunodeficiency virus, hematologic/lymphatic malignancy; immunosuppressive therapy other than systemic corticosteroids within the previous 16 weeks; systemic corticosteroids |
Measured Values
| Participants less than 24 months of age | Participants 24-59 months of age with asthma | Participants 24-59 months of age with wheezing | Participants 24-59 months of age with immunosuppression | |
|---|---|---|---|---|
|
Number of
Participants Analyzed [units:participants] |
775 | 3457 | 5821 | 361 |
| Vaccinating physician specialty: Other [units: Number of physicians] |
103 | 346 | 581 | 37 |
No statistical analysis provided for Vaccinating physician specialty: Other
5. Primary Outcome Measure: Vaccinating physician specialty: Unknown [ Time Frame: 2009-2010 ]
| Measure Type | Primary |
|---|---|
| Measure Name | Vaccinating physician specialty: Unknown |
| Measure Description | Specialty of vaccinating physician who provided FluMist |
| Time Frame | 2009-2010 |
| Safety Issue? | No |
Population Description
| 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. |
|---|
| General population of participants aged < 24 months, participants 24-59 months with asthma, participants 24-59 months with wheeing, and participants 24-59 months with immunosuppression. |
Reporting Groups
| Description | |
|---|---|
| Participants less than 24 months of age | Participants less than 24 months of age |
| Participants 24-59 months of age with asthma | Participants 24-59 months of age with a claim associated with a diagnosis of asthma |
| Participants 24-59 months of age with wheezing | Participants 24-59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing |
| Participants 24-59 months of age with immunosuppression | Participants 24-59 months of age who had claims associated with any of the following: transplantation, congenital immune deficiency, symptomatic human immunodeficiency virus, hematologic/lymphatic malignancy; immunosuppressive therapy other than systemic corticosteroids within the previous 16 weeks; systemic corticosteroids |
Measured Values
| Participants less than 24 months of age | Participants 24-59 months of age with asthma | Participants 24-59 months of age with wheezing | Participants 24-59 months of age with immunosuppression | |
|---|---|---|---|---|
|
Number of
Participants Analyzed [units:participants] |
775 | 3457 | 5821 | 361 |
| Vaccinating physician specialty: Unknown [units: Number of physicians] |
59 | 189 | 269 | 20 |
No statistical analysis provided for Vaccinating physician specialty: Unknown
6. Primary Outcome Measure: Geographic region: Northeastern [ Time Frame: 2009-2010 ]
| Measure Type | Primary |
|---|---|
| Measure Name | Geographic region: Northeastern |
| Measure Description | Geographic region of parents' residence among participants receiving FluMist |
| Time Frame | 2009-2010 |
| Safety Issue? | No |
Population Description
| 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. |
|---|
| General population of participants aged < 24 months, participants 24-59 months with asthma, participants 24-59 months with wheeing, and participants 24-59 months with immunosuppression. |
Reporting Groups
| Description | |
|---|---|
| Participants less than 24 months of age | Participants less than 24 months of age |
| Participants 24-59 months of age with asthma | Participants 24-59 months of age with a claim associated with a diagnosis of asthma |
| Participants 24-59 months of age with wheezing | Participants 24-59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing |
| Participants 24-59 months of age with immunosuppression | Participants 24-59 months of age who had claims associated with any of the following: transplantation, congenital immune deficiency, symptomatic human immunodeficiency virus, hematologic/lymphatic malignancy; immunosuppressive therapy other than systemic corticosteroids within the previous 16 weeks; systemic corticosteroids |
Measured Values
| Participants less than 24 months of age | Participants 24-59 months of age with asthma | Participants 24-59 months of age with wheezing | Participants 24-59 months of age with immunosuppression | |
|---|---|---|---|---|
|
Number of
Participants Analyzed [units:participants] |
775 | 3457 | 5821 | 361 |
| Geographic region: Northeastern [units: Number of participants] |
64 | 353 | 392 | 20 |
No statistical analysis provided for Geographic region: Northeastern
7. Primary Outcome Measure: Geographic region: North central [ Time Frame: 2009-2010 ]
| Measure Type | Primary |
|---|---|
| Measure Name | Geographic region: North central |
| Measure Description | Geographic region of parents' residence among participants receiving FluMist |
| Time Frame | 2009-2010 |
| Safety Issue? | No |
Population Description
| 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. |
|---|
| General population of participants aged < 24 months, participants 24-59 months with asthma, participants 24-59 months with wheeing, and participants 24-59 months with immunosuppression. |
Reporting Groups
| Description | |
|---|---|
| Participants less than 24 months of age | Participants less than 24 months of age |
| Participants 24-59 months of age with asthma | Participants 24-59 months of age with a claim associated with a diagnosis of asthma |
| Participants 24-59 months of age with wheezing | Participants 24-59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing |
| Participants 24-59 months of age with immunosuppression | Participants 24-59 months of age who had claims associated with any of the following: transplantation, congenital immune deficiency, symptomatic human immunodeficiency virus, hematologic/lymphatic malignancy; immunosuppressive therapy other than systemic corticosteroids within the previous 16 weeks; systemic corticosteroids |
Measured Values
| Participants less than 24 months of age | Participants 24-59 months of age with asthma | Participants 24-59 months of age with wheezing | Participants 24-59 months of age with immunosuppression | |
|---|---|---|---|---|
|
Number of
Participants Analyzed [units:participants] |
775 | 3457 | 5821 | 361 |
| Geographic region: North central [units: Number of participants] |
214 | 755 | 1635 | 101 |
No statistical analysis provided for Geographic region: North central
8. Primary Outcome Measure: Geographic region: Southern [ Time Frame: 2009-2010 ]
| Measure Type | Primary |
|---|---|
| Measure Name | Geographic region: Southern |
| Measure Description | Geographic region of parents' residence among participants receiving FluMist |
| Time Frame | 2009-2010 |
| Safety Issue? | No |
Population Description
| 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. |
|---|
| General population of participants aged < 24 months, participants 24-59 months with asthma, participants 24-59 months with wheeing, and participants 24-59 months with immunosuppression. |
Reporting Groups
| Description | |
|---|---|
| Participants less than 24 months of age | Participants less than 24 months of age |
| Participants 24-59 months of age with asthma | Participants 24-59 months of age with a claim associated with a diagnosis of asthma |
| Participants 24-59 months of age with wheezing | Participants 24-59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing |
| Participants 24-59 months of age with immunosuppression | Participants 24-59 months of age who had claims associated with any of the following: transplantation, congenital immune deficiency, symptomatic human immunodeficiency virus, hematologic/lymphatic malignancy; immunosuppressive therapy other than systemic corticosteroids within the previous 16 weeks; systemic corticosteroids |
Measured Values
| Participants less than 24 months of age | Participants 24-59 months of age with asthma | Participants 24-59 months of age with wheezing | Participants 24-59 months of age with immunosuppression | |
|---|---|---|---|---|
|
Number of
Participants Analyzed [units:participants] |
775 | 3457 | 5821 | 361 |
| Geographic region: Southern [units: Number of participants] |
364 | 1937 | 3127 | 204 |
No statistical analysis provided for Geographic region: Southern
9. Primary Outcome Measure: Geographic region: Western [ Time Frame: 2009-2010 ]
| Measure Type | Primary |
|---|---|
| Measure Name | Geographic region: Western |
| Measure Description | Geographic region of parents' residence among participants receiving FluMist |
| Time Frame | 2009-2010 |
| Safety Issue? | No |
Population Description
| 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. |
|---|
| General population of participants aged < 24 months, participants 24-59 months with asthma, participants 24-59 months with wheeing, and participants 24-59 months with immunosuppression. |
Reporting Groups
| Description | |
|---|---|
| Participants less than 24 months of age | Participants less than 24 months of age |
| Participants 24-59 months of age with asthma | Participants 24-59 months of age with a claim associated with a diagnosis of asthma |
| Participants 24-59 months of age with wheezing | Participants 24-59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing |
| Participants 24-59 months of age with immunosuppression | Participants 24-59 months of age who had claims associated with any of the following: transplantation, congenital immune deficiency, symptomatic human immunodeficiency virus, hematologic/lymphatic malignancy; immunosuppressive therapy other than systemic corticosteroids within the previous 16 weeks; systemic corticosteroids |
Measured Values
| Participants less than 24 months of age | Participants 24-59 months of age with asthma | Participants 24-59 months of age with wheezing | Participants 24-59 months of age with immunosuppression | |
|---|---|---|---|---|
|
Number of
Participants Analyzed [units:participants] |
775 | 3457 | 5821 | 361 |
| Geographic region: Western [units: Number of participants] |
132 | 404 | 662 | 36 |
No statistical analysis provided for Geographic region: Western
10. Primary Outcome Measure: Number of outpatient visits: 0 [ Time Frame: 2009-2010 ]
| Measure Type | Primary |
|---|---|
| Measure Name | Number of outpatient visits: 0 |
| Measure Description | Among participants vaccinated with FluMist, the number who had 0 outpatient visits in the 3 months prior to vaccination |
| Time Frame | 2009-2010 |
| Safety Issue? | No |
Population Description
| 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. |
|---|
| General population of participants aged < 24 months, participants 24-59 months with asthma, participants 24-59 months with wheeing, and participants 24-59 months with immunosuppression. |
Reporting Groups
| Description | |
|---|---|
| Participants less than 24 months of age | Participants less than 24 months of age |
| Participants 24-59 months of age with asthma | Participants 24-59 months of age with a claim associated with a diagnosis of asthma |
| Participants 24-59 months of age with wheezing | Participants 24-59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing |
| Participants 24-59 months of age with immunosuppression | Participants 24-59 months of age who had claims associated with any of the following: transplantation, congenital immune deficiency, symptomatic human immunodeficiency virus, hematologic/lymphatic malignancy; immunosuppressive therapy other than systemic corticosteroids within the previous 16 weeks; systemic corticosteroids |
Measured Values
| Participants less than 24 months of age | Participants 24-59 months of age with asthma | Participants 24-59 months of age with wheezing | Participants 24-59 months of age with immunosuppression | |
|---|---|---|---|---|
|
Number of
Participants Analyzed [units:participants] |
775 | 3457 | 5821 | 361 |
| Number of outpatient visits: 0 [units: Number of participants] |
147 | 910 | 1994 | 61 |
No statistical analysis provided for Number of outpatient visits: 0
11. Primary Outcome Measure: Number of outpatient visits: 1 [ Time Frame: 2009-2010 ]
| Measure Type | Primary |
|---|---|
| Measure Name | Number of outpatient visits: 1 |
| Measure Description | Among participants vaccinated with FluMist, the number who had 1 outpatient visit in the 3 months prior to vaccination |
| Time Frame | 2009-2010 |
| Safety Issue? | No |
Population Description
| 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. |
|---|
| General population of participants aged < 24 months, participants 24-59 months with asthma, participants 24-59 months with wheeing, and participants 24-59 months with immunosuppression. |
Reporting Groups
| Description | |
|---|---|
| Participants less than 24 months of age | Participants less than 24 months of age |
| Participants 24-59 months of age with asthma | Participants 24-59 months of age with a claim associated with a diagnosis of asthma |
| Participants 24-59 months of age with wheezing | Participants 24-59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing |
| Participants 24-59 months of age with immunosuppression | Participants 24-59 months of age who had claims associated with any of the following: transplantation, congenital immune deficiency, symptomatic human immunodeficiency virus, hematologic/lymphatic malignancy; immunosuppressive therapy other than systemic corticosteroids within the previous 16 weeks; systemic corticosteroids |
Measured Values
| Participants less than 24 months of age | Participants 24-59 months of age with asthma | Participants 24-59 months of age with wheezing | Participants 24-59 months of age with immunosuppression | |
|---|---|---|---|---|
|
Number of
Participants Analyzed [units:participants] |
775 | 3457 | 5821 | 361 |
| Number of outpatient visits: 1 [units: Number of participants] |
246 | 987 | 1724 | 99 |
No statistical analysis provided for Number of outpatient visits: 1
12. Primary Outcome Measure: Number of outpatient visits: 2 or more [ Time Frame: 2009-2010 ]
| Measure Type | Primary |
|---|---|
| Measure Name | Number of outpatient visits: 2 or more |
| Measure Description | Among participants vaccinated with FluMist, the number who had 2 or more outpatient visits in the 3 months prior to vaccination |
| Time Frame | 2009-2010 |
| Safety Issue? | No |
Population Description
| 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. |
|---|
| General population of participants aged < 24 months, participants 24-59 months with asthma, participants 24-59 months with wheeing, and participants 24-59 months with immunosuppression. |
Reporting Groups
| Description | |
|---|---|
| Participants less than 24 months of age | Participants less than 24 months of age |
| Participants 24-59 months of age with asthma | Participants 24-59 months of age with a claim associated with a diagnosis of asthma |
| Participants 24-59 months of age with wheezing | Participants 24-59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing |
| Participants 24-59 months of age with immunosuppression | Participants 24-59 months of age who had claims associated with any of the following: transplantation, congenital immune deficiency, symptomatic human immunodeficiency virus, hematologic/lymphatic malignancy; immunosuppressive therapy other than systemic corticosteroids within the previous 16 weeks; systemic corticosteroids |
Measured Values
| Participants less than 24 months of age | Participants 24-59 months of age with asthma | Participants 24-59 months of age with wheezing | Participants 24-59 months of age with immunosuppression | |
|---|---|---|---|---|
|
Number of
Participants Analyzed [units:participants] |
775 | 3457 | 5821 | 361 |
| Number of outpatient visits: 2 or more [units: Number of participants] |
382 | 1560 | 2103 | 201 |
No statistical analysis provided for Number of outpatient visits: 2 or more
13. Primary Outcome Measure: Number of days with a respiratory claim in 28 days prior to vaccination: 0 [ Time Frame: 2009-2010 ]
| Measure Type | Primary |
|---|---|
| Measure Name | Number of days with a respiratory claim in 28 days prior to vaccination: 0 |
| Measure Description | Among participants vaccinated with FluMist, the number of days with a respiratory claim (asthma, acute respiratory distress, bronchospasm, influenza, respiratory syncytial virus, bronchiolitis, bronchitis, pneumonia, croup, sinusitis, adenovirus infection, coxsackie virus infection, rhinovirus infection, nasopharyngitis, laryngitis and tracheitis, upper respiratory infection, cough) in the 28 days prior to vaccination. |
| Time Frame | 2009-2010 |
| Safety Issue? | No |
Population Description
| 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. |
|---|
| General population of participants aged < 24 months, participants 24-59 months with asthma, participants 24-59 months with wheeing, and participants 24-59 months with immunosuppression. |
Reporting Groups
| Description | |
|---|---|
| Participants less than 24 months of age | Participants less than 24 months of age |
| Participants 24-59 months of age with asthma | Participants 24-59 months of age with a claim associated with a diagnosis of asthma |
| Participants 24-59 months of age with wheezing | Participants 24-59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing |
| Participants 24-59 months of age with immunosuppression | Participants 24-59 months of age who had claims associated with any of the following: transplantation, congenital immune deficiency, symptomatic human immunodeficiency virus, hematologic/lymphatic malignancy; immunosuppressive therapy other than systemic corticosteroids within the previous 16 weeks; systemic corticosteroids |
Measured Values
| Participants less than 24 months of age | Participants 24-59 months of age with asthma | Participants 24-59 months of age with wheezing | Participants 24-59 months of age with immunosuppression | |
|---|---|---|---|---|
|
Number of
Participants Analyzed [units:participants] |
775 | 3457 | 5821 | 361 |
| Number of days with a respiratory claim in 28 days prior to vaccination: 0 [units: Number of participants] |
677 | 2778 | 5049 | 245 |
No statistical analysis provided for Number of days with a respiratory claim in 28 days prior to vaccination: 0
14. Primary Outcome Measure: Number of days with a respiratory claim in 28 days prior to vaccination: 1 [ Time Frame: 2009-2010 ]
| Measure Type | Primary |
|---|---|
| Measure Name | Number of days with a respiratory claim in 28 days prior to vaccination: 1 |
| Measure Description | Among participants vaccinated with FluMist, the number of days with a respiratory claim (asthma, acute respiratory distress, bronchospasm, influenza, respiratory syncytial virus, bronchiolitis, bronchitis, pneumonia, croup, sinusitis, adenovirus infection, coxsackie virus infection, rhinovirus infection, nasopharyngitis, laryngitis and tracheitis, upper respiratory infection, cough) in the 28 days prior to vaccination. |
| Time Frame | 2009-2010 |
| Safety Issue? | No |
Population Description
| 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. |
|---|
| General population of participants aged < 24 months, participants 24-59 months with asthma, participants 24-59 months with wheeing, and participants 24-59 months with immunosuppression. |
Reporting Groups
| Description | |
|---|---|
| Participants less than 24 months of age | Participants less than 24 months of age |
| Participants 24-59 months of age with asthma | Participants 24-59 months of age with a claim associated with a diagnosis of asthma |
| Participants 24-59 months of age with wheezing | Participants 24-59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing |
| Participants 24-59 months of age with immunosuppression | Participants 24-59 months of age who had claims associated with any of the following: transplantation, congenital immune deficiency, symptomatic human immunodeficiency virus, hematologic/lymphatic malignancy; immunosuppressive therapy other than systemic corticosteroids within the previous 16 weeks; systemic corticosteroids |
Measured Values
| Participants less than 24 months of age | Participants 24-59 months of age with asthma | Participants 24-59 months of age with wheezing | Participants 24-59 months of age with immunosuppression | |
|---|---|---|---|---|
|
Number of
Participants Analyzed [units:participants] |
775 | 3457 | 5821 | 361 |
| Number of days with a respiratory claim in 28 days prior to vaccination: 1 [units: Number of participants] |
95 | 670 | 769 | 114 |
No statistical analysis provided for Number of days with a respiratory claim in 28 days prior to vaccination: 1
15. Primary Outcome Measure: Number of days with a respiratory claim in 28 days prior to vaccination: 2 or more [ Time Frame: 2009-2010 ]
| Measure Type | Primary |
|---|---|
| Measure Name | Number of days with a respiratory claim in 28 days prior to vaccination: 2 or more |
| Measure Description | Among participants vaccinated with FluMist, the number of days with a respiratory claim (asthma, acute respiratory distress, bronchospasm, influenza, respiratory syncytial virus, bronchiolitis, bronchitis, pneumonia, croup, sinusitis, adenovirus infection, coxsackie virus infection, rhinovirus infection, nasopharyngitis, laryngitis and tracheitis, upper respiratory infection, cough) in the 28 days prior to vaccination. |
| Time Frame | 2009-2010 |
| Safety Issue? | No |
Population Description
| 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. |
|---|
| General population of participants aged < 24 months, participants 24-59 months with asthma, participants 24-59 months with wheeing, and participants 24-59 months with immunosuppression. |
Reporting Groups
| Description | |
|---|---|
| Participants less than 24 months of age | Participants less than 24 months of age |
| Participants 24-59 months of age with asthma | Participants 24-59 months of age with a claim associated with a diagnosis of asthma |
| Participants 24-59 months of age with wheezing | Participants 24-59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing |
| Participants 24-59 months of age with immunosuppression | Participants 24-59 months of age who had claims associated with any of the following: transplantation, congenital immune deficiency, symptomatic human immunodeficiency virus, hematologic/lymphatic malignancy; immunosuppressive therapy other than systemic corticosteroids within the previous 16 weeks; systemic corticosteroids |
Measured Values
| Participants less than 24 months of age | Participants 24-59 months of age with asthma | Participants 24-59 months of age with wheezing | Participants 24-59 months of age with immunosuppression | |
|---|---|---|---|---|
|
Number of
Participants Analyzed [units:participants] |
775 | 3457 | 5821 | 361 |
| Number of days with a respiratory claim in 28 days prior to vaccination: 2 or more [units: Number of participants] |
3 | 9 | 3 | 2 |
No statistical analysis provided for Number of days with a respiratory claim in 28 days prior to vaccination: 2 or more
Serious Adverse Events
| Time Frame | 2009-2010 |
|---|---|
| Additional Description | This retrospective database study examined claims for hospitalizations or emergency department visits within 42 days after claims for influenza vaccination. No participants were entered in the study and no investigational product was administered. |
Reporting Groups
| Description | |
|---|---|
| Participants less than 24 months of age | Participants less than 24 months of age |
| Children 24-59 months with asthma | No text entered. |
| Participants 24-59 months of age with wheezing | Participants 24-59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing |
| Participants 24-59 months of age with immunosuppression | Participants 24-59 months of age who had claims associated with any of the following: transplantation, congenital immune deficiency, symptomatic human immunodeficiency virus, hematologic/lymphatic malignancy; immunosuppressive therapy other than systemic corticosteroids within the previous 16 weeks; systemic corticosteroids |
Serious Adverse Events
| Participants less than 24 months of age | Children 24-59 months with asthma | Participants 24-59 months of age with wheezing | Participants 24-59 months of age with immunosuppression | |
|---|---|---|---|---|
| Total, serious adverse events | ||||
| # participants affected / at risk | 0/0 | 0/0 | 0/0 | 0/0 |
Other Adverse Events
| Time Frame | 2009-2010 |
|---|---|
| Additional Description | This retrospective database study examined claims for hospitalizations or emergency department visits within 42 days after claims for influenza vaccination. No participants were entered in the study and no investigational product was administered. |
Frequency Threshold
| Threshold above which other adverse events are reported | 0% |
|---|
Reporting Groups
| Description | |
|---|---|
| Participants less than 24 months of age | Participants less than 24 months of age |
| Children 24-59 months with asthma | No text entered. |
| Participants 24-59 months of age with wheezing | Participants 24-59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing |
| Participants 24-59 months of age with immunosuppression | Participants 24-59 months of age who had claims associated with any of the following: transplantation, congenital immune deficiency, symptomatic human immunodeficiency virus, hematologic/lymphatic malignancy; immunosuppressive therapy other than systemic corticosteroids within the previous 16 weeks; systemic corticosteroids |
Other Adverse Events
| Participants less than 24 months of age | Children 24-59 months with asthma | Participants 24-59 months of age with wheezing | Participants 24-59 months of age with immunosuppression | |
|---|---|---|---|---|
| Total, other (not including serious) adverse events | ||||
| # participants affected / at risk | 0/0 | 0/0 | 0/0 | 0/0 |
Certain Agreements
| 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:
|
Limitations and Caveats
| 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 |
|---|
| No text entered. |
Results Point of Contact
| Name/Title: | Chris Ambrose |
| Organization: | MedImmune, LLC |
| Phone | 301-398-0000 |
| E-mail: | [email protected] |
Contacts
Investigators
Principal Investigator
Chris Ambrose
MedImmune Inc.
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hOOU56EiQQwzYiEgvA%2F1WSUkzNJdSnkXHe%2FW9pk7hECC%2BwL93HtqZoHMhhQFTXb15o5kBPRqpoKMYKle3oENsCgSj17p6aTD3gyYNEAhFrk4AnaHTn0kRFHH7dlMdIwGDIdC5YsdhoIP14dLI1b2D70lykG2HbUWNfpakw%2F9%2FxngpaHGqJ7E3sLaXwBMAfYo7i0T4TpG8mit82Njb5gTpBtI5ABFrHAri9BbKAh2pBnjtWL93xeFg2DlvO5JPMqTCXBFrT4xf0ikKOlLqDNtxGOhIdfnsmvLvKD9nOugYNsWrYybQkTwy3Y7XVGHQPHL4aPO6DDqGOh6h4S5uqxn7YQuiuQC0cYf5iNS59WuBjlU3JzJg%2Fk7oxGsMBvedzM%2Bx%2BjM33VVJJyrWBi64XxP6lmX5qmXaft9OCx7I6ILOFTsOJ57ilsXY3PwhZ8GxWV%2FdQr0ykoxPFSdnc0BNF%2BQU3Qx0OhHO8vDExgZPUBS4TKe5BDoXAEdV2c%2FkdFm8cwCdE2kFPb48FV3ZRFKKI9BSIUjtOlwidg%2FQ6QDOmsBoJe8pKqVXf1aTTsJ2HAE6UhoJu5%2B9k%2BYWoKOoXdM8Oso6TKFFB3CwDwDw4A8A9SEQ0wvC9dZArLUWOOo1AfDDIehdWwye5PanQ%2BkKryMNdKTHAHrdiGFV3gYYitdw9GIeRclfPbR9a9CxKqxZ%2BSyCGaQtwQQQEYVNzZxWA3o5dB6TeL%2FfEHRMl7c3pgA%2FwShOz5S4GIX30H7I6zMLdE5KOKOhCFCzgBNcdfyklPK3yLrsQGckNsdq3AuZjwxKe8c4RQ6u2TuAjpbv5F7b2k7uUBClUZBr2I4j6ai4vIeN5sbaTLfpNHpJWofjihzQ0VzmQ%2B54gw7S8B0yL7S5quEII%2FvFuKyv14SZZxbpV9lrIeCRoCOjTodPVkMXn8Xcbp7XHUBHnr5hdUc5zSz9WcvAn7EphpNzg8x3K9CR%2FDh0IjvAIzd5eB2DwIvXQuEXRlrLkE3HOKh6JNgSlJkLH141cuXjW5Jkftka4i5%2Bepf38UMp5Q2PZyToDMXmdKQdydyXFpT6iUQ%2B3wF05GnmGoPbSaa5rA90MVycs%2Bh3%2BVAJbrjwCd9oY7nMZa2gUzZCY8xwI3Oj%2FqW2DbU7BByGWhb6lu2NUe8k2ZUi7nsPR%2Bj3z0spf%2FRe3kBHIdppPVfJpzlITCwbt0aqsDXmdE%2B%2BO4COBGZ3g3VOoUgS4rC02TkMwGC8%2FhFeRTmOQ0kRRTWjUhWH8rG3sum0NZcHWOhub0rEtQJMDVPCSNuwCUHyWmlnSCuudNq5zncUdLQof2%2F%2Fz%2Fw9VEsHHXLQ6dbNGRmdoWKtC9D0TizYUO6VYdM5LIwCOp6HaAcinstcibwGaUxbQxu3rMFC5JSgczkex1sn5UBQC1HxdhTayxoyN1GvOhKit6bS0InxIrdql1xrrKVX9At8ixQKUj22ioqKzcyrLogQEbkXiPQh1YxJOlJd9Fhh1u%2FwyIGP3etvqMMVdHogcXZkSmLipo8bl8QD9MAUO5diOwm0FHxVvzdqpCCMG8wC3RS4skVojgYHdoLWaPy8MhzFHhEZsTC8bskmJd0oGI76lTVqtFPxEPDVqf8swfJmoNP4U3r98N9qdKwR8m%2Fd3wSe4LVx%2BDrtNlKjBeYJe5ssErc6Ejp3kIOvSZokPgTgEC%2BAZ2Bj4bzhSkniYLgn6ICPEX%2B2xmmNYgSBjtQHL8ctKJZ0npVsLXZ0%2FIiGVK8y7dxCSm13ayR7ko6h5kXGjcA2bBRew4WXcdBqHUfajbwjQadHf6q0yI2GvI8D2N9SvWInuQY8%2BJk2LM9l4uPtFilzJFG0w0vPSvvHQZIxDtTeGq2SZivFOhQ4KkBH2qgifBF9B2MEaAJokI5kFnyLNEigc4jNQWJcpAHrHaNolWR%2BMBKSIKOh4m7hoIAV%2FzLoNOCxYockSTa3pCJR8uTGu4FOYCNry2rS%2Fh6gM0hzGn8oRqYjTfW2gNm2obZpbW11aZTDcshTF4yEjm5pSrrG35BmTqU7WJ0Vdicxf%2Bd0gR6BvgAVJLvRs6tP3BabClRDFeF3DdE3VHw7jLIsZBvqFNe90RakC34FDewt2wnWqwMkiciM4dsVNe0dGvOurzbfXX%2FNkAvRHOPkAWtRBom8t5XTNOZgpaCQFAF6QbpUT7imAvPiYId17g2ySQfbens3irBSsbwOM76n1BOznK0zDuJFuZ6cF1dVyVMr2nri4Ab%2Fk9TIU2N2bbA8PurrK9w7FVlcdoigH%2FRJe8n7HHwq0zFwEF6SZLxO3cLsXgP5%2B%2BtFARazAXX4psw3g3JsvDDWTT2RedvtIr%2BHpwcDIEofouqARBtSn59sff8H57piU0311KcAAAAASUVORK5CYII%3D%22%2F%3E%0A%3C%2Fdefs%3E%0A%3C%2Fsvg%3E%0A)
