Trial Outcomes & Findings for A Post Marketing Evaluation of the Effectiveness of FluMist Risk Minimization Plan in Children (NCT NCT00626808)
NCT ID: NCT00626808
Last Updated: 2014-08-12
Results Overview
Among participants up to 59 months of age who received any flu vaccine, number who received FluMist
COMPLETED
321697 participants
2009-2010
2014-08-12
Participant Flow
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.
Participant milestones
| Measure |
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
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
254464
|
34316
|
30011
|
2906
|
|
Overall Study
COMPLETED
|
254464
|
34316
|
30011
|
2906
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Post Marketing Evaluation of the Effectiveness of FluMist Risk Minimization Plan in Children
Baseline characteristics by cohort
| Measure |
Participants Less Than 24 Months of Age
n=254464 Participants
Participants less than 24 months of age
|
Participants 24-59 Months of Age With Asthma
n=34316 Participants
Participants 24-59 months of age with a claim associated with a diagnosis of asthma
|
Participants 24-59 Months of Age With Wheezing
n=30011 Participants
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
n=2906 Participants
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
|
Total
n=321697 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
< 24 months
|
254464 children
n=5 Participants
|
0 children
n=7 Participants
|
0 children
n=5 Participants
|
0 children
n=4 Participants
|
254464 children
n=21 Participants
|
|
Age, Customized
>= 24 months
|
0 children
n=5 Participants
|
34316 children
n=7 Participants
|
30011 children
n=5 Participants
|
2906 children
n=4 Participants
|
67233 children
n=21 Participants
|
|
Sex: Female, Male
Female
|
NA Participants
n=5 Participants
|
NA Participants
n=7 Participants
|
NA Participants
n=5 Participants
|
NA Participants
n=4 Participants
|
NA Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
NA Participants
n=5 Participants
|
NA Participants
n=7 Participants
|
NA Participants
n=5 Participants
|
NA Participants
n=4 Participants
|
NA Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 2009-2010Population: 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.
Among participants up to 59 months of age who received any flu vaccine, number who received FluMist
Outcome measures
| Measure |
Participants Less Than 24 Months of Age
n=254464 Participants
Participants less than 24 months of age
|
Participants 24-59 Months of Age With Asthma
n=34316 Participants
Participants 24-59 months of age with a claim associated with a diagnosis of asthma
|
Participants 24-59 Months of Age With Wheezing
n=30011 Participants
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
n=2906 Participants
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
|
|---|---|---|---|---|
|
FluMist Use in Participants up to 59 Months of Age
|
775 Number of participants
|
3457 Number of participants
|
5821 Number of participants
|
361 Number of participants
|
PRIMARY outcome
Timeframe: 2009-2010Population: 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.
Specialty of vaccinating physician who provided FluMist.
Outcome measures
| Measure |
Participants Less Than 24 Months of Age
n=775 Participants
Participants less than 24 months of age
|
Participants 24-59 Months of Age With Asthma
n=3457 Participants
Participants 24-59 months of age with a claim associated with a diagnosis of asthma
|
Participants 24-59 Months of Age With Wheezing
n=5821 Participants
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
n=361 Participants
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
|
|---|---|---|---|---|
|
Vaccinating Physician Specialty: Pediatrician or Pediatric Specialist
|
553 Number of physicians
|
2782 Number of physicians
|
4704 Number of physicians
|
291 Number of physicians
|
PRIMARY outcome
Timeframe: 2009-2010Population: 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.
Specialty of vaccinating physician who provided FluMist
Outcome measures
| Measure |
Participants Less Than 24 Months of Age
n=775 Participants
Participants less than 24 months of age
|
Participants 24-59 Months of Age With Asthma
n=3457 Participants
Participants 24-59 months of age with a claim associated with a diagnosis of asthma
|
Participants 24-59 Months of Age With Wheezing
n=5821 Participants
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
n=361 Participants
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
|
|---|---|---|---|---|
|
Vaccinating Physician Specialty: General/Family Practitioner
|
60 Number of physicians
|
140 Number of physicians
|
267 Number of physicians
|
13 Number of physicians
|
PRIMARY outcome
Timeframe: 2009-2010Population: 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.
Specialty of vaccinating physician who provided FluMist
Outcome measures
| Measure |
Participants Less Than 24 Months of Age
n=775 Participants
Participants less than 24 months of age
|
Participants 24-59 Months of Age With Asthma
n=3457 Participants
Participants 24-59 months of age with a claim associated with a diagnosis of asthma
|
Participants 24-59 Months of Age With Wheezing
n=5821 Participants
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
n=361 Participants
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
|
|---|---|---|---|---|
|
Vaccinating Physician Specialty: Other
|
103 Number of physicians
|
346 Number of physicians
|
581 Number of physicians
|
37 Number of physicians
|
PRIMARY outcome
Timeframe: 2009-2010Population: 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.
Specialty of vaccinating physician who provided FluMist
Outcome measures
| Measure |
Participants Less Than 24 Months of Age
n=775 Participants
Participants less than 24 months of age
|
Participants 24-59 Months of Age With Asthma
n=3457 Participants
Participants 24-59 months of age with a claim associated with a diagnosis of asthma
|
Participants 24-59 Months of Age With Wheezing
n=5821 Participants
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
n=361 Participants
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
|
|---|---|---|---|---|
|
Vaccinating Physician Specialty: Unknown
|
59 Number of physicians
|
189 Number of physicians
|
269 Number of physicians
|
20 Number of physicians
|
PRIMARY outcome
Timeframe: 2009-2010Population: 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.
Geographic region of parents' residence among participants receiving FluMist
Outcome measures
| Measure |
Participants Less Than 24 Months of Age
n=775 Participants
Participants less than 24 months of age
|
Participants 24-59 Months of Age With Asthma
n=3457 Participants
Participants 24-59 months of age with a claim associated with a diagnosis of asthma
|
Participants 24-59 Months of Age With Wheezing
n=5821 Participants
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
n=361 Participants
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
|
|---|---|---|---|---|
|
Geographic Region: Northeastern
|
64 Number of participants
|
353 Number of participants
|
392 Number of participants
|
20 Number of participants
|
PRIMARY outcome
Timeframe: 2009-2010Population: 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.
Geographic region of parents' residence among participants receiving FluMist
Outcome measures
| Measure |
Participants Less Than 24 Months of Age
n=775 Participants
Participants less than 24 months of age
|
Participants 24-59 Months of Age With Asthma
n=3457 Participants
Participants 24-59 months of age with a claim associated with a diagnosis of asthma
|
Participants 24-59 Months of Age With Wheezing
n=5821 Participants
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
n=361 Participants
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
|
|---|---|---|---|---|
|
Geographic Region: North Central
|
214 Number of participants
|
755 Number of participants
|
1635 Number of participants
|
101 Number of participants
|
PRIMARY outcome
Timeframe: 2009-2010Population: 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.
Geographic region of parents' residence among participants receiving FluMist
Outcome measures
| Measure |
Participants Less Than 24 Months of Age
n=775 Participants
Participants less than 24 months of age
|
Participants 24-59 Months of Age With Asthma
n=3457 Participants
Participants 24-59 months of age with a claim associated with a diagnosis of asthma
|
Participants 24-59 Months of Age With Wheezing
n=5821 Participants
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
n=361 Participants
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
|
|---|---|---|---|---|
|
Geographic Region: Southern
|
364 Number of participants
|
1937 Number of participants
|
3127 Number of participants
|
204 Number of participants
|
PRIMARY outcome
Timeframe: 2009-2010Population: 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.
Geographic region of parents' residence among participants receiving FluMist
Outcome measures
| Measure |
Participants Less Than 24 Months of Age
n=775 Participants
Participants less than 24 months of age
|
Participants 24-59 Months of Age With Asthma
n=3457 Participants
Participants 24-59 months of age with a claim associated with a diagnosis of asthma
|
Participants 24-59 Months of Age With Wheezing
n=5821 Participants
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
n=361 Participants
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
|
|---|---|---|---|---|
|
Geographic Region: Western
|
132 Number of participants
|
404 Number of participants
|
662 Number of participants
|
36 Number of participants
|
PRIMARY outcome
Timeframe: 2009-2010Population: 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.
Among participants vaccinated with FluMist, the number who had 0 outpatient visits in the 3 months prior to vaccination
Outcome measures
| Measure |
Participants Less Than 24 Months of Age
n=775 Participants
Participants less than 24 months of age
|
Participants 24-59 Months of Age With Asthma
n=3457 Participants
Participants 24-59 months of age with a claim associated with a diagnosis of asthma
|
Participants 24-59 Months of Age With Wheezing
n=5821 Participants
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
n=361 Participants
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
|
|---|---|---|---|---|
|
Number of Outpatient Visits: 0
|
147 Number of participants
|
910 Number of participants
|
1994 Number of participants
|
61 Number of participants
|
PRIMARY outcome
Timeframe: 2009-2010Population: 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.
Among participants vaccinated with FluMist, the number who had 1 outpatient visit in the 3 months prior to vaccination
Outcome measures
| Measure |
Participants Less Than 24 Months of Age
n=775 Participants
Participants less than 24 months of age
|
Participants 24-59 Months of Age With Asthma
n=3457 Participants
Participants 24-59 months of age with a claim associated with a diagnosis of asthma
|
Participants 24-59 Months of Age With Wheezing
n=5821 Participants
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
n=361 Participants
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
|
|---|---|---|---|---|
|
Number of Outpatient Visits: 1
|
246 Number of participants
|
987 Number of participants
|
1724 Number of participants
|
99 Number of participants
|
PRIMARY outcome
Timeframe: 2009-2010Population: 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.
Among participants vaccinated with FluMist, the number who had 2 or more outpatient visits in the 3 months prior to vaccination
Outcome measures
| Measure |
Participants Less Than 24 Months of Age
n=775 Participants
Participants less than 24 months of age
|
Participants 24-59 Months of Age With Asthma
n=3457 Participants
Participants 24-59 months of age with a claim associated with a diagnosis of asthma
|
Participants 24-59 Months of Age With Wheezing
n=5821 Participants
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
n=361 Participants
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
|
|---|---|---|---|---|
|
Number of Outpatient Visits: 2 or More
|
382 Number of participants
|
1560 Number of participants
|
2103 Number of participants
|
201 Number of participants
|
PRIMARY outcome
Timeframe: 2009-2010Population: 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.
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.
Outcome measures
| Measure |
Participants Less Than 24 Months of Age
n=775 Participants
Participants less than 24 months of age
|
Participants 24-59 Months of Age With Asthma
n=3457 Participants
Participants 24-59 months of age with a claim associated with a diagnosis of asthma
|
Participants 24-59 Months of Age With Wheezing
n=5821 Participants
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
n=361 Participants
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
|
|---|---|---|---|---|
|
Number of Days With a Respiratory Claim in 28 Days Prior to Vaccination: 0
|
677 Number of participants
|
2778 Number of participants
|
5049 Number of participants
|
245 Number of participants
|
PRIMARY outcome
Timeframe: 2009-2010Population: 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.
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.
Outcome measures
| Measure |
Participants Less Than 24 Months of Age
n=775 Participants
Participants less than 24 months of age
|
Participants 24-59 Months of Age With Asthma
n=3457 Participants
Participants 24-59 months of age with a claim associated with a diagnosis of asthma
|
Participants 24-59 Months of Age With Wheezing
n=5821 Participants
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
n=361 Participants
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
|
|---|---|---|---|---|
|
Number of Days With a Respiratory Claim in 28 Days Prior to Vaccination: 1
|
95 Number of participants
|
670 Number of participants
|
769 Number of participants
|
114 Number of participants
|
PRIMARY outcome
Timeframe: 2009-2010Population: 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.
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.
Outcome measures
| Measure |
Participants Less Than 24 Months of Age
n=775 Participants
Participants less than 24 months of age
|
Participants 24-59 Months of Age With Asthma
n=3457 Participants
Participants 24-59 months of age with a claim associated with a diagnosis of asthma
|
Participants 24-59 Months of Age With Wheezing
n=5821 Participants
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
n=361 Participants
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
|
|---|---|---|---|---|
|
Number of Days With a Respiratory Claim in 28 Days Prior to Vaccination: 2 or More
|
3 Number of participants
|
9 Number of participants
|
3 Number of participants
|
2 Number of participants
|
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
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER