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A Post Marketing Evaluation of the Effectiveness of FluMist Risk Minimization Plan in Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00626808
Recruitment Status : Completed
First Posted : February 29, 2008
Results First Posted : August 12, 2014
Last Update Posted : August 12, 2014
Sponsor:
Collaborator:
RTI International
Information provided by (Responsible Party):
MedImmune LLC

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Retrospective
Conditions Asthma
Wheezing
Immunosuppression
Intervention Drug: No Intervention
Enrollment 321697
Recruitment Details 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  
Arm/Group Title 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
Hide Arm/Group Description Participants less than 24 months of age Participants 24-59 months of age with a claim associated with a diagnosis of asthma 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 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
Period Title: Overall Study
Started 254464 34316 30011 2906
Completed 254464 34316 30011 2906
Not Completed 0 0 0 0
Arm/Group Title 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
Hide Arm/Group Description Participants less than 24 months of age Participants 24-59 months of age with a claim associated with a diagnosis of asthma 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 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 of all reporting groups
Overall Number of Baseline Participants 254464 34316 30011 2906 321697
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Children
Number Analyzed 254464 participants 34316 participants 30011 participants 2906 participants 321697 participants
< 24 months 254464 0 0 0 254464
>= 24 months 0 34316 30011 2906 67233
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 254464 participants 34316 participants 30011 participants 2906 participants 321697 participants
Female NA [2]  NA [2]  NA [2]  NA [2]  NA [3] 
Male NA [2]  NA [2]  NA [2]  NA [2]  NA [3] 
[1]
Measure Description: Gender was not collected for this database study.
[2]
Gender was not collected from database.
[3]
Total not calculated because data are not available (NA) in one or more arms.
1.Primary Outcome
Title FluMist Use in Participants up to 59 Months of Age
Hide Description Among participants up to 59 months of age who received any flu vaccine, number who received FluMist
Time Frame 2009-2010
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 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
Hide Arm/Group Description:
Participants less than 24 months of age
Participants 24-59 months of age with a claim associated with a diagnosis of asthma
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 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 Number of Participants Analyzed 254464 34316 30011 2906
Measure Type: Number
Unit of Measure: Number of participants
775 3457 5821 361
2.Primary Outcome
Title Vaccinating Physician Specialty: Pediatrician or Pediatric Specialist
Hide Description Specialty of vaccinating physician who provided FluMist.
Time Frame 2009-2010
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 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
Hide Arm/Group Description:
Participants less than 24 months of age
Participants 24-59 months of age with a claim associated with a diagnosis of asthma
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 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 Number of Participants Analyzed 775 3457 5821 361
Measure Type: Number
Unit of Measure: Number of physicians
553 2782 4704 291
3.Primary Outcome
Title Vaccinating Physician Specialty: General/Family Practitioner
Hide Description Specialty of vaccinating physician who provided FluMist
Time Frame 2009-2010
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 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
Hide Arm/Group Description:
Participants less than 24 months of age
Participants 24-59 months of age with a claim associated with a diagnosis of asthma
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 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 Number of Participants Analyzed 775 3457 5821 361
Measure Type: Number
Unit of Measure: Number of physicians
60 140 267 13
4.Primary Outcome
Title Vaccinating Physician Specialty: Other
Hide Description Specialty of vaccinating physician who provided FluMist
Time Frame 2009-2010
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 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
Hide Arm/Group Description:
Participants less than 24 months of age
Participants 24-59 months of age with a claim associated with a diagnosis of asthma
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 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 Number of Participants Analyzed 775 3457 5821 361
Measure Type: Number
Unit of Measure: Number of physicians
103 346 581 37
5.Primary Outcome
Title Vaccinating Physician Specialty: Unknown
Hide Description Specialty of vaccinating physician who provided FluMist
Time Frame 2009-2010
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 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
Hide Arm/Group Description:
Participants less than 24 months of age
Participants 24-59 months of age with a claim associated with a diagnosis of asthma
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 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 Number of Participants Analyzed 775 3457 5821 361
Measure Type: Number
Unit of Measure: Number of physicians
59 189 269 20
6.Primary Outcome
Title Geographic Region: Northeastern
Hide Description Geographic region of parents' residence among participants receiving FluMist
Time Frame 2009-2010
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 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
Hide Arm/Group Description:
Participants less than 24 months of age
Participants 24-59 months of age with a claim associated with a diagnosis of asthma
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 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 Number of Participants Analyzed 775 3457 5821 361
Measure Type: Number
Unit of Measure: Number of participants
64 353 392 20
7.Primary Outcome
Title Geographic Region: North Central
Hide Description Geographic region of parents' residence among participants receiving FluMist
Time Frame 2009-2010
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 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
Hide Arm/Group Description:
Participants less than 24 months of age
Participants 24-59 months of age with a claim associated with a diagnosis of asthma
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 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 Number of Participants Analyzed 775 3457 5821 361
Measure Type: Number
Unit of Measure: Number of participants
214 755 1635 101
8.Primary Outcome
Title Geographic Region: Southern
Hide Description Geographic region of parents' residence among participants receiving FluMist
Time Frame 2009-2010
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 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
Hide Arm/Group Description:
Participants less than 24 months of age
Participants 24-59 months of age with a claim associated with a diagnosis of asthma
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 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 Number of Participants Analyzed 775 3457 5821 361
Measure Type: Number
Unit of Measure: Number of participants
364 1937 3127 204
9.Primary Outcome
Title Geographic Region: Western
Hide Description Geographic region of parents' residence among participants receiving FluMist
Time Frame 2009-2010
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 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
Hide Arm/Group Description:
Participants less than 24 months of age
Participants 24-59 months of age with a claim associated with a diagnosis of asthma
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 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 Number of Participants Analyzed 775 3457 5821 361
Measure Type: Number
Unit of Measure: Number of participants
132 404 662 36
10.Primary Outcome
Title Number of Outpatient Visits: 0
Hide Description Among participants vaccinated with FluMist, the number who had 0 outpatient visits in the 3 months prior to vaccination
Time Frame 2009-2010
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 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
Hide Arm/Group Description:
Participants less than 24 months of age
Participants 24-59 months of age with a claim associated with a diagnosis of asthma
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 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 Number of Participants Analyzed 775 3457 5821 361
Measure Type: Number
Unit of Measure: Number of participants
147 910 1994 61
11.Primary Outcome
Title Number of Outpatient Visits: 1
Hide Description Among participants vaccinated with FluMist, the number who had 1 outpatient visit in the 3 months prior to vaccination
Time Frame 2009-2010
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 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
Hide Arm/Group Description:
Participants less than 24 months of age
Participants 24-59 months of age with a claim associated with a diagnosis of asthma
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 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 Number of Participants Analyzed 775 3457 5821 361
Measure Type: Number
Unit of Measure: Number of participants
246 987 1724 99
12.Primary Outcome
Title Number of Outpatient Visits: 2 or More
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 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
Hide Arm/Group Description:
Participants less than 24 months of age
Participants 24-59 months of age with a claim associated with a diagnosis of asthma
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 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 Number of Participants Analyzed 775 3457 5821 361
Measure Type: Number
Unit of Measure: Number of participants
382 1560 2103 201
13.Primary Outcome
Title Number of Days With a Respiratory Claim in 28 Days Prior to Vaccination: 0
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 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
Hide Arm/Group Description:
Participants less than 24 months of age
Participants 24-59 months of age with a claim associated with a diagnosis of asthma
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 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 Number of Participants Analyzed 775 3457 5821 361
Measure Type: Number
Unit of Measure: Number of participants
677 2778 5049 245
14.Primary Outcome
Title Number of Days With a Respiratory Claim in 28 Days Prior to Vaccination: 1
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 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
Hide Arm/Group Description:
Participants less than 24 months of age
Participants 24-59 months of age with a claim associated with a diagnosis of asthma
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 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 Number of Participants Analyzed 775 3457 5821 361
Measure Type: Number
Unit of Measure: Number of participants
95 670 769 114
15.Primary Outcome
Title Number of Days With a Respiratory Claim in 28 Days Prior to Vaccination: 2 or More
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 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
Hide Arm/Group Description:
Participants less than 24 months of age
Participants 24-59 months of age with a claim associated with a diagnosis of asthma
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 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 Number of Participants Analyzed 775 3457 5821 361
Measure Type: Number
Unit of Measure: Number of participants
3 9 3 2
Time Frame 2009-2010
Adverse Event Reporting 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.
 
Arm/Group Title 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
Hide Arm/Group Description Participants less than 24 months of age [Not Specified] 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 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
All-Cause Mortality
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
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Hide 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
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/0   0/0 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
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
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   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.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chris Ambrose
Organization: MedImmune, LLC
Phone: 301-398-0000
EMail: ambrosec@medimmune.com
Layout table for additonal information
Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT00626808    
Other Study ID Numbers: MI-MA175
First Submitted: February 20, 2008
First Posted: February 29, 2008
Results First Submitted: July 21, 2014
Results First Posted: August 12, 2014
Last Update Posted: August 12, 2014