Safety Study to Evaluate FluMist in Immunocompromised Children

This study has been completed.
Sponsor:
Information provided by:
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT00112112
First received: May 27, 2005
Last updated: July 31, 2012
Last verified: July 2012
Results First Received: February 27, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Cancer
Interventions: Biological: FluMist
Biological: Placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A total of 20 participants, 10 in the FluMist group and 10 in the placebo group, were enrolled in the study between 08Aug2005 and 31Mar2008 at 4 sites in the USA.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 20 participants were randomized in a 1:1 ratio to the FluMist or placebo group. Participants were enrolled on a staggered schedule to assess safety. Four participants were enrolled and treated in 2005, 8 in 2006, and 8 in 2007; each subset was assessed for vaccine-related serious adverse events prior to enrollment of the next subset.

Reporting Groups
  Description
Placebo Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
FluMist The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10 to 7th TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.

Participant Flow:   Overall Study
    Placebo     FluMist  
STARTED     10     10  
COMPLETED     10     10  
NOT COMPLETED     0     0  



  Baseline Characteristics
  Hide Baseline Characteristics

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.
No text entered.

Reporting Groups
  Description
Placebo Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
FluMist The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10 to 7th TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
Total Total of all reporting groups

Baseline Measures
    Placebo     FluMist     Total  
Number of Participants  
[units: participants]
  10     10     20  
Age  
[units: Years]
Mean ± Standard Deviation
  12.2  ± 3.8     12.2  ± 3.9     12.2  ± 3.8  
Gender  
[units: Participants]
     
Female     4     7     11  
Male     6     3     9  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants Who Had Reactogenicity Events (REs)   [ Time Frame: 0-42 days after study vaccination ]

2.  Primary:   Number of Serious Adverse Events (SAEs)   [ Time Frame: 0-180 days after study vaccination ]

3.  Primary:   Number of Participants Who Had Adverse Events (AEs)   [ Time Frame: 0-42 days after study vaccination ]

4.  Primary:   Number of Significant New Medical Conditions (SNMCs)   [ Time Frame: 43-180 days after study vaccination ]

5.  Secondary:   Number of Participants Shedding Vaccine-like Virus   [ Time Frame: 3-5 days after study vaccination ]

6.  Secondary:   Number of Participants Shedding Vaccine-like Virus   [ Time Frame: 7-10 days after study vaccination ]

7.  Secondary:   Number of Participants Shedding Vaccine-like Virus   [ Time Frame: 14-28 days after study vaccination ]

8.  Secondary:   Number of Participants Shedding Vaccine-like Virus   [ Time Frame: 35-42 days after study vaccination ]

9.  Secondary:   Number of Participants Shedding Vaccine-like Virus   [ Time Frame: Unscheduled visits occurring during days 0-42 days after study vaccination ]

10.  Secondary:   T- and B-lymphocyte Subsets by Flow Cytometry - CD19   [ Time Frame: pre-dosing (Day 0) ]

11.  Secondary:   T- and B-lymphocyte Subsets by Flow Cytometry - CD3   [ Time Frame: pre-dosing (Day 0) ]

12.  Secondary:   T- and B-lymphocyte Subsets by Flow Cytometry - CD4   [ Time Frame: pre-dosing (Day 0) ]

13.  Secondary:   T- and B-lymphocyte Subsets by Flow Cytometry - CD8   [ Time Frame: pre-dosing (Day 0) ]

14.  Secondary:   T- and B-lymphocyte Subsets by Flow Cytometry - CD19   [ Time Frame: Day 7-10 ]

15.  Secondary:   T- and B-lymphocyte Subsets by Flow Cytometry - CD3   [ Time Frame: Day 7-10 ]

16.  Secondary:   T- and B-lymphocyte Subsets by Flow Cytometry - CD4   [ Time Frame: Day 7-10 ]

17.  Secondary:   T- and B-lymphocyte Subsets by Flow Cytometry - CD8   [ Time Frame: Day 7-10 ]

18.  Secondary:   Interferon (INF)-Gamma   [ Time Frame: pre-dosing (Day 0) ]

19.  Secondary:   INF-Gamma   [ Time Frame: Day 7-10 ]

20.  Secondary:   INF-Gamma   [ Time Frame: Day 35-42 ]

21.  Secondary:   Interleukin (IL)-4   [ Time Frame: pre-dosing (Day 0) ]

22.  Secondary:   IL-4   [ Time Frame: Day 7-10 ]

23.  Secondary:   IL-4   [ Time Frame: Day 35-42 ]

24.  Secondary:   Human Leukocyte Antigen (HLA) Matched Tetramers CD8+   [ Time Frame: pre-dosing (Day 0) ]

25.  Secondary:   HLA Matched Tetramers CD8+   [ Time Frame: Day 7-10 ]

26.  Secondary:   HLA Matched Tetramers CD8+   [ Time Frame: Day 35-42 ]

27.  Secondary:   Number of Participants Who Experienced a ≥ 4-fold Rise in Serum Influenza A/H1N1 Hemagglutination Inhibition (HAI) Titers   [ Time Frame: Baseline to Day 35-42 ]

28.  Secondary:   Number of Participants Who Experienced a ≥ 4-fold Rise in Serum Influenza A/H3N2 HAI Titers   [ Time Frame: Baseline to Day 35-42 ]

29.  Secondary:   Number of Participants Who Experienced a ≥ 4-fold Rise in Serum Influenza B HAI Titers   [ Time Frame: Baseline to Day 35-42 ]

30.  Secondary:   Number of Participants Who Experienced a ≥ 4-fold Rise in Influenza A/H1N1 Microneutralization Titers   [ Time Frame: Baseline to Day 35-42 ]

31.  Secondary:   Number of Participants Who Experienced a ≥ 4-fold Rise in Influenza A/H3N2 Microneutralization Titers   [ Time Frame: Baseline to Day 35-42 ]

32.  Secondary:   Number of Participants Who Experienced a ≥ 4-fold Rise in Influenza B Microneutralization Titers   [ Time Frame: Baseline to Day 35-42 ]

33.  Secondary:   Influenza A/H1N1 Immunoglobulin A (IgA)   [ Time Frame: pre-dosing (Day 0) ]

34.  Secondary:   Influenza A/H1N1 IgA   [ Time Frame: Day 3-5 ]

35.  Secondary:   Influenza A/H1N1 IgA   [ Time Frame: Day 7-10 ]

36.  Secondary:   Influenza A/H1N1 IgA   [ Time Frame: Day 14-28 ]

37.  Secondary:   Influenza A/H1N1 IgA   [ Time Frame: Day 35-42 ]

38.  Secondary:   Influenza A/H3N2 IgA   [ Time Frame: pre-dosing (Day 0) ]

39.  Secondary:   Influenza A/H3N2 IgA   [ Time Frame: Day 3-5 ]

40.  Secondary:   Influenza A/H3N2 IgA   [ Time Frame: Day 7-10 ]

41.  Secondary:   Influenza A/H3N2 IgA   [ Time Frame: Day 14-28 ]

42.  Secondary:   Influenza A/H3N2 IgA   [ Time Frame: Day 35-42 ]

43.  Secondary:   Influenza B IgA   [ Time Frame: pre-dosing (Day 0) ]

44.  Secondary:   Influenza B IgA   [ Time Frame: Day 3-5 ]

45.  Secondary:   Influenza B IgA   [ Time Frame: Day 7-10 ]

46.  Secondary:   Influenza B IgA   [ Time Frame: Day 14-28 ]

47.  Secondary:   Influenza B IgA   [ Time Frame: Day 35-42 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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.


  More Information
  Hide More Information

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:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Raburn Mallory
Organization: MedImmune, LLC
phone: 301-398-0000
e-mail: malloryr@medimmune.com


Publications of Results:

Responsible Party: Raburn Mallory, Senior Director, Clinical Development, MedImmune, LLC
ClinicalTrials.gov Identifier: NCT00112112     History of Changes
Other Study ID Numbers: MI-CP114
Study First Received: May 27, 2005
Results First Received: February 27, 2012
Last Updated: July 31, 2012
Health Authority: United States: Food and Drug Administration