Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| RTI International | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a retrospective cohort study of children included in a large medical insurance claims database.
To evaluate the rate of FluMist administration compared to other influenza vaccine use in the following pediatric populations:
To describe, in children in the above populations who receive FluMist, the type and number of Emergency Room visits or hospitalizations associated with an insurance claim within 42 days of receiving FluMist
To explore the rationale for FluMist immunization of pediatric populations that are excluded from recommended usage by characterizing the use in these populations
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Children less than 24 months of age |
| |
| 2 | Children 24 to 59 months of age with a claim associated with a diagnosis of asthma |
| |
| 3 | Children 24 to 59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing |
| |
| 4 | Children 24-59 months of age with immunosuppression |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No Intervention | Drug | There were no interventions. No subjects were enrolled in this retrospective database study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| FluMist Use in Participants up to 59 Months of Age | Among participants up to 59 months of age who received any flu vaccine, number who received FluMist | 2009-2010 |
| Vaccinating Physician Specialty: Pediatrician or Pediatric Specialist | Specialty of vaccinating physician who provided FluMist. | 2009-2010 |
| Vaccinating Physician Specialty: General/Family Practitioner | Specialty of vaccinating physician who provided FluMist | 2009-2010 |
| Vaccinating Physician Specialty: Other | Specialty of vaccinating physician who provided FluMist | 2009-2010 |
| Vaccinating Physician Specialty: Unknown | Specialty of vaccinating physician who provided FluMist | 2009-2010 |
| Geographic Region: Northeastern | Geographic region of parents' residence among participants receiving FluMist | 2009-2010 |
| Geographic Region: North Central | Geographic region of parents' residence among participants receiving FluMist | 2009-2010 |
| Geographic Region: Southern | Geographic region of parents' residence among participants receiving FluMist |
Not provided
Not provided
Children less than 24 months of age during August through January/February.
Children <24 to 59 months of age during August through January/February, with:
Children <24 to 59 months of age during August through January/February, without any claims associated with a diagnosis of asthma, but with at least one dispensing for SABA, as indicated by pharmacy claims during a defined 12-month period.
Children 24 to 59 months of age during August to January/February with evidence of immunosuppression prior to the date of influenza vaccination based on available medical and pharmacy claims.
Not provided
Not provided
Not provided
Not provided
Children < 60 months of age.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Chris Ambrose, M.D. | MedImmune LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Research Triangle Park | North Carolina | United States |
Not provided
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Participants Less Than 24 Months of Age | Participants less than 24 months of age |
| FG001 | Participants 24-59 Months of Age With Asthma | Participants 24-59 months of age with a claim associated with a diagnosis of asthma |
| FG002 | 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 |
| FG003 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Participants Less Than 24 Months of Age | Participants less than 24 months of age |
| BG001 | Participants 24-59 Months of Age With Asthma | Participants 24-59 months of age with a claim associated with a diagnosis of asthma |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | FluMist Use in Participants up to 59 Months of Age | Among participants up to 59 months of age who received any flu vaccine, number who received FluMist | 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. | Posted | Number | Number of participants | 2009-2010 |
|
2009-2010
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Participants Less Than 24 Months of Age | Participants less than 24 months of age |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chris Ambrose | MedImmune, LLC | 301-398-0000 | ambrosec@medimmune.com |
Not provided
| ID | Term |
|---|---|
| D001249 | Asthma |
| D012135 | Respiratory Sounds |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| 2009-2010 |
| Geographic Region: Western | Geographic region of parents' residence among participants receiving FluMist | 2009-2010 |
| Number of Outpatient Visits: 0 | Among participants vaccinated with FluMist, the number who had 0 outpatient visits in the 3 months prior to vaccination | 2009-2010 |
| Number of Outpatient Visits: 1 | Among participants vaccinated with FluMist, the number who had 1 outpatient visit in the 3 months prior to vaccination | 2009-2010 |
| Number of Outpatient Visits: 2 or More | Among participants vaccinated with FluMist, the number who had 2 or more outpatient visits in the 3 months prior to vaccination | 2009-2010 |
| Number of Days With a Respiratory Claim in 28 Days Prior to Vaccination: 0 | 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. | 2009-2010 |
| Number of Days With a Respiratory Claim in 28 Days Prior to Vaccination: 1 | 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. | 2009-2010 |
| Number of Days With a Respiratory Claim in 28 Days Prior to Vaccination: 2 or More | 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. | 2009-2010 |
| BG002 | 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 |
| BG003 | 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 |
| BG004 | Total | Total of all reporting groups |
| children |
|
| Sex: Female, Male | Gender was not collected for this database study. | Count of Participants | Participants |
|
| OG002 | 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 |
| OG003 | 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 |
|
|
| Primary | Vaccinating Physician Specialty: Pediatrician or Pediatric Specialist | Specialty of vaccinating physician who provided FluMist. | 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. | Posted | Number | Number of physicians | 2009-2010 |
|
|
|
| Primary | Vaccinating Physician Specialty: General/Family Practitioner | Specialty of vaccinating physician who provided FluMist | 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. | Posted | Number | Number of physicians | 2009-2010 |
|
|
|
| Primary | Vaccinating Physician Specialty: Other | Specialty of vaccinating physician who provided FluMist | 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. | Posted | Number | Number of physicians | 2009-2010 |
|
|
|
| Primary | Vaccinating Physician Specialty: Unknown | Specialty of vaccinating physician who provided FluMist | 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. | Posted | Number | Number of physicians | 2009-2010 |
|
|
|
| Primary | Geographic Region: Northeastern | Geographic region of parents' residence among participants receiving FluMist | 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. | Posted | Number | Number of participants | 2009-2010 |
|
|
|
| Primary | Geographic Region: North Central | Geographic region of parents' residence among participants receiving FluMist | 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. | Posted | Number | Number of participants | 2009-2010 |
|
|
|
| Primary | Geographic Region: Southern | Geographic region of parents' residence among participants receiving FluMist | 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. | Posted | Number | Number of participants | 2009-2010 |
|
|
|
| Primary | Geographic Region: Western | Geographic region of parents' residence among participants receiving FluMist | 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. | Posted | Number | Number of participants | 2009-2010 |
|
|
|
| Primary | Number of Outpatient Visits: 0 | Among participants vaccinated with FluMist, the number who had 0 outpatient visits in the 3 months prior to vaccination | 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. | Posted | Number | Number of participants | 2009-2010 |
|
|
|
| Primary | Number of Outpatient Visits: 1 | Among participants vaccinated with FluMist, the number who had 1 outpatient visit in the 3 months prior to vaccination | 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. | Posted | Number | Number of participants | 2009-2010 |
|
|
|
| Primary | Number of Outpatient Visits: 2 or More | Among participants vaccinated with FluMist, the number who had 2 or more outpatient visits in the 3 months prior to vaccination | 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. | Posted | Number | Number of participants | 2009-2010 |
|
|
|
| Primary | Number of Days With a Respiratory Claim in 28 Days Prior to Vaccination: 0 | 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. | 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. | Posted | Number | Number of participants | 2009-2010 |
|
|
|
| Primary | Number of Days With a Respiratory Claim in 28 Days Prior to Vaccination: 1 | 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. | 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. | Posted | Number | Number of participants | 2009-2010 |
|
|
|
| Primary | Number of Days With a Respiratory Claim in 28 Days Prior to Vaccination: 2 or More | 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. | 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. | Posted | Number | Number of participants | 2009-2010 |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Children 24-59 Months With Asthma | 0 | 0 | 0 | 0 |
| EG002 | 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 | 0 | 0 | 0 | 0 |
| EG003 | 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 | 0 | 0 | 0 | 0 |
MedImmune has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it is understood that results shall be published regardless of outcome. The PIs also agree for data to be presented first as a joint, multi-center publication.
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |