A Phase 2 Study to Evaluate Immune Responses of FluMist®

This study has been completed.
Sponsor:
Information provided by:
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT00461981
First received: April 16, 2007
Last updated: January 12, 2010
Last verified: January 2010
Results First Received: May 29, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Bio-equivalence Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Influenza Vaccine
Interventions: Biological: TIV, Trivalent Inactivated Influenza Virus Vaccine
Biological: FluMist, Influenza Virus Vaccine Live

  Participant Flow
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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 101 subjects were entered and randomized into the study at 15 sites in the United States of America between 07 May 2007 and 28 Jun 2007.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
FluMist, Influenza Virus Vaccine Live FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
TIV, Trivalent Inactivated Influenza Virus Vaccine TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses

Participant Flow:   Overall Study
    FluMist, Influenza Virus Vaccine Live     TIV, Trivalent Inactivated Influenza Virus Vaccine  
STARTED     50     51  
COMPLETED     39     42  
NOT COMPLETED     11     9  
Lost to Follow-up                 9                 6  
Withdrawal by Subject                 2                 3  



  Baseline Characteristics
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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
FluMist, Influenza Virus Vaccine Live FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
TIV, Trivalent Inactivated Influenza Virus Vaccine TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
Total Total of all reporting groups

Baseline Measures
    FluMist, Influenza Virus Vaccine Live     TIV, Trivalent Inactivated Influenza Virus Vaccine     Total  
Number of Participants  
[units: participants]
  50     51     101  
Age  
[units: months]
Mean ± Standard Deviation
  23.1  ± 7.0     24.4  ± 7.0     23.8  ± 7.0  
Age, Customized  
[units: participants]
     
12 to < 24 months     26     24     50  
24 to < 36 months     24     27     51  
Gender  
[units: participants]
     
Female     22     21     43  
Male     28     30     58  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     22     16     38  
White     26     31     57  
More than one race     2     4     6  
Unknown or Not Reported     0     0     0  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     6     9     15  
Not Hispanic or Latino     44     42     86  
Unknown or Not Reported     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     50     51     101  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Subjects With Antigenically Matched Strain-specific Hemagglutination Inhibition (HAI)Seroconversion Following the First Dose - H1N1 /wt A/New Caledonia/20/99 Influenza Strain   [ Time Frame: Post Dose 1 (28 to 42 days post Dose 1) ]

2.  Primary:   Percentage of Subjects With Antigenically Matched Strain-specific Hemagglutination Inhibition (HAI) Seroconversion Following the Second Dose - H1N1 /wt A/New Caledonia/20/99 Influenza Strain   [ Time Frame: Post Dose 2 (28 to 35 days post Dose 2) ]

3.  Primary:   Percentage of Subjects With Antigenically Matched Strain-specific Hemagglutination Inhibition (HAI)Seroconversion Following the First Dose - H1N1 /ca A/New Caledonia/20/99 Influenza Strain   [ Time Frame: Post Dose 1 (28 to 42 days post Dose 1) ]

4.  Primary:   Percentage of Subjects With Antigenically Matched Strain-specific Hemagglutination Inhibition (HAI)Seroconversion Following the Second Dose - H1N1 /ca A/New Caledonia/20/99 Influenza Strain   [ Time Frame: Post Dose 2 (28 to 35 days post Dose 2) ]

5.  Primary:   Percentage of Subjects With Antigenically Matched Strain-specific Hemagglutination Inhibition (HAI)Seroconversion Following the First Dose - H3N2 /wt A/Wisconsin/67/05 Influenza Strain   [ Time Frame: Post Dose 1 (28 to 42 days post Dose 1) ]

6.  Primary:   Percentage of Subjects With Antigenically Matched Strain-specific Hemagglutination Inhibition (HAI) Seroconversion Following the Second Dose - H3N2 /wt A/Wisconsin/67/05 Influenza Strain   [ Time Frame: Post Dose 2 (28 to 35 days post Dose 2) ]

7.  Primary:   Percentage of Subjects With Antigenically Matched Strain-specific Hemagglutination Inhibition (HAI) Seroconversion Following the First Dose - B /wt B/Malaysia/2506/04 Influenza Strain   [ Time Frame: Post Dose 1 (28 to 42 days post Dose 1) ]

8.  Primary:   Percentage of Subjects With Antigenically Matched Strain-specific Hemagglutination Inhibition (HAI) Seroconversion Following the Second Dose - B /wt B/Malaysia/2506/04 Influenza Strain   [ Time Frame: Post Dose 2 (28 to 35 days post Dose 2) ]

9.  Primary:   Percentage of Subjects With Antigenically Mismatched Strain-specific Hemagglutination Inhibition (HAI) Seroconversion Following the First Dose - H1N1 /wt A/Solomon Island/3/06 Influenza Strain   [ Time Frame: Post Dose 1 (28 to 42 days post Dose 1) ]

10.  Primary:   Percentage of Subjects With Antigenically Mismatched Strain-specific Hemagglutination Inhibition (HAI) Seroconversion Following the Second Dose - H1N1 /wt A/Solomon Island/3/06 Influenza Strain   [ Time Frame: Post Dose 2 (28 to 35 days post Dose 2) ]

11.  Primary:   Percentage of Subjects With Antigenically Mismatched Strain-specific Hemagglutination Inhibition (HAI) Seroconversion Following the First Dose - H3N2 /wt A/Brisbane/10/2007 Influenza Strain   [ Time Frame: Post Dose 1 (28 to 42 days post Dose 1) ]

12.  Primary:   Percentage of Subjects With Antigenically Mismatched Strain-specific Hemagglutination Inhibition (HAI) Seroconversion Following the Second Dose - H3N2 /wt A/Brisbane/10/2007 Influenza Strain   [ Time Frame: Post Dose 2 (28 to 35 days post Dose 2) ]

13.  Primary:   Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - H1N1 /wt A/New Caledonia/20/99 Influenza Strain   [ Time Frame: Post Dose 1 (28 to 42 days post Dose 1) ]

14.  Primary:   Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - H1N1 /wt A/New Caledonia/20/99 Influenza Strain   [ Time Frame: Post Dose 2 (28 to 35 days post Dose 2) ]

15.  Primary:   Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - H1N1 /ca A/New Caledonia/20/99 Influenza Strain   [ Time Frame: Post Dose 1 (28 to 42 days post Dose 1) ]

16.  Primary:   Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - H1N1 /ca A/New Caledonia/20/99 Influenza Strain   [ Time Frame: Post Dose 2 (28 to 35 days post Dose 2) ]

17.  Primary:   Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - H3N2 /wt A/Wisconsin/67/05 Influenza Strain   [ Time Frame: Post Dose 1 (28 to 42 days post Dose 1) ]

18.  Primary:   Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - H3N2 /wt A/Wisconsin/67/05 Influenza Strain   [ Time Frame: Post Dose 2 (28 to 35 days post Dose 2) ]

19.  Primary:   Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - B /wt B/Malaysia/2506/04 Influenza Strain   [ Time Frame: Post Dose 1 (28 to 42 days post Dose 1) ]

20.  Primary:   Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - B /wt B/Malaysia/2506/04 Influenza Strain   [ Time Frame: Post Dose 2 (28 to 35 days post Dose 2) ]

21.  Primary:   Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - H1N1 /wt A/Solomon Island/3/06 Influenza Strain   [ Time Frame: Post Dose 1 (28 to 42 days post Dose 1) ]

22.  Primary:   Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - H1N1 /wt A/Solomon Island/3/06 Influenza Strain   [ Time Frame: Post Dose 2 (28 to 35 days post Dose 2) ]

23.  Primary:   Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - H3N2 /wt A/Brisbane/10/2007 Influenza Strain   [ Time Frame: Post Dose 1 (28 to 42 days post Dose 1) ]

24.  Primary:   Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - H3N2 /wt A/Brisbane/10/2007 Influenza Strain   [ Time Frame: Post Dose 2 (28 to 35 days post Dose 2) ]

25.  Primary:   Percentage of Subjects With Antigenically Matched Strain-specific Microneutralization Seroconversion Following the First Dose - H1N1 /wt A/New Caledonia/20/99 Influenza Strain   [ Time Frame: Post Dose 1 (28 to 42 days post Dose 1) ]

26.  Primary:   Percentage of Subjects With Antigenically Matched Strain-specific Microneutralization Seroconversion Following the Second Dose - H1N1 /wt A/New Caledonia/20/99 Influenza Strain   [ Time Frame: Post Dose 2 (28 to 35 days post Dose 2) ]

27.  Primary:   Percentage of Subjects With Antigenically Matched Strain-specific Microneutralization Seroconversion Following the First Dose - H1N1 /ca A/New Caledonia/20/99 Influenza Strain   [ Time Frame: Post Dose 1 (28 to 42 days post Dose 1) ]

28.  Primary:   Percentage of Subjects With Antigenically Matched Strain-specific Microneutralization Seroconversion Following the Second Dose - H1N1 /ca A/New Caledonia/20/99 Influenza Strain   [ Time Frame: Post Dose 2 (28 to 35 days post Dose 2) ]

29.  Primary:   Percentage of Subjects With Antigenically Matched Strain-specific Microneutralization Seroconversion Following the First Dose - H3N2 /wt A/Wisconsin/67/05 Influenza Strain   [ Time Frame: Post Dose 1 (28 to 42 days post Dose 1) ]

30.  Primary:   Percentage of Subjects With Antigenically Matched Strain-specific Microneutralization Seroconversion Following the Second Dose - H3N2 /wt A/Wisconsin/67/05 Influenza Strain   [ Time Frame: Post Dose 2 (28 to 35 days post Dose 2) ]

31.  Primary:   Percentage of Subjects With Antigenically Matched Strain-specific Microneutralization Seroconversion Following the First Dose - B /wt B/Malaysia/2506/04 Influenza Strain   [ Time Frame: Post Dose 1 (28 to 42 days post Dose 1) ]

32.  Primary:   Percentage of Subjects With Antigenically Matched Strain-specific Microneutralization Seroconversion Following the Second Dose - B /wt B/Malaysia/2506/04 Influenza Strain   [ Time Frame: Post Dose 2 (28 to 35 days post Dose 2) ]

33.  Primary:   Percentage of Subjects With Antigenically Mismatched Strain-specific Microneutralization Seroconversion Following the First Dose - H1N1 /wt A/Solomon Island/3/06 Influenza Strain   [ Time Frame: Post Dose 1 (28 to 42 days post Dose 1) ]

34.  Primary:   Percentage of Subjects With Antigenically Mismatched Strain-specific Microneutralization Seroconversion Following the Second Dose - H1N1 /wt A/Solomon Island/3/06 Influenza Strain   [ Time Frame: Post Dose 2 (28 to 35 days post Dose 2) ]

35.  Primary:   Percentage of Subjects With Antigenically Mismatched Strain-specific Microneutralization Seroconversion Following the First Dose - H3N2 /wt A/Brisbane/10/2007 Influenza Strain   [ Time Frame: Post Dose 1 (28 to 42 days post Dose 1) ]

36.  Primary:   Percentage of Subjects With Antigenically Mismatched Strain-specific Microneutralization Seroconversion Following the Second Dose - H3N2 /wt A/Brisbane/10/2007 Influenza Strain   [ Time Frame: Post Dose 2 (28 to 35 days post Dose 2) ]

37.  Primary:   Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - H1N1 /wt A/New Caledonia/20/99 Influenza Strain   [ Time Frame: Post Dose 1 (28 to 42 days post Dose 1) ]

38.  Primary:   Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - H1N1 /wt A/New Caledonia/20/99 Influenza Strain   [ Time Frame: Post Dose 2 (28 to 35 days post Dose 2) ]

39.  Primary:   Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - H1N1 /ca A/New Caledonia/20/99 Influenza Strain   [ Time Frame: Post Dose 1 (28 to 42 days post Dose 1) ]

40.  Primary:   Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - H1N1 /ca A/New Caledonia/20/99 Influenza Strain   [ Time Frame: Post Dose 2 (28 to 35 days post Dose 2) ]

41.  Primary:   Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - H3N2 /wt A/Wisconsin/67/05 Influenza Strain   [ Time Frame: Post Dose 1 (28 to 42 days post Dose 1) ]

42.  Primary:   Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - H3N2 /wt A/Wisconsin/67/05 Influenza Strain   [ Time Frame: Post Dose 2 (28 to 35 days post Dose 2) ]

43.  Primary:   Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - B /wt B/Malaysia/2506/04 Influenza Strain   [ Time Frame: Post Dose 1 (28 to 42 days post Dose 1) ]

44.  Primary:   Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - H1N1 /wt A/Solomon Island/3/06 Influenza Strain   [ Time Frame: Post Dose 1 (28 to 42 days post Dose 1) ]

45.  Primary:   Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - B /wt B/Malaysia/2506/04 Influenza Strain   [ Time Frame: Post Dose 2 (28 to 35 days post Dose 2) ]

46.  Primary:   Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - H1N1 /wt A/Solomon Island/3/06 Influenza Strain   [ Time Frame: Post Dose 2 (28 to 35 days post Dose 2) ]

47.  Primary:   Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - H3N2 /wt A/Brisbane/10/2007 Influenza Strain   [ Time Frame: Post Dose 1 (28 to 42 days post Dose 1) ]

48.  Primary:   Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - H3N2 /wt A/Brisbane/10/2007 Influenza Strain   [ Time Frame: Post Dose 2 (28 to 35 days post Dose 2) ]

49.  Primary:   Immunogenicity Response by B-cell IgG and IgA ELISPOT Assay   [ Time Frame: Post Dose 1 (7 to 10 days post Dose 1) ]

50.  Primary:   Immunogenicity Response by B-cell IgG and IgA ELISPOT Assay   [ Time Frame: Post Dose 2 (7 to 10 days post Dose 2) ]

51.  Primary:   Median Fold-Rises in the Number of Interferon-gamma Elispots Per 200,000 Peripheral Blood Mononuclear Cells (PBMCs) by T-cell Elispot Assay Following the First Dose   [ Time Frame: Post Dose 1 (28 to 42 days post Dose 1) ]

52.  Primary:   Median Fold-Rises in the Number of Interferon-gamma Elispots Per 200,000 Peripheral Blood Mononuclear Cells (PBMCs) by T-cell Elispot Assay   [ Time Frame: Post Dose 2 (28 to 35 days post Dose 2) ]

53.  Primary:   Distribution of Interferon (IFN)-Alpha/Beta Gene Signature Scores Among All Subjects   [ Time Frame: Post Dose 1 (28 to 42 days post Dose 1) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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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: Christopher Ambrose, MD
Organization: MedImmune, LLC
phone: 301-398-0000
e-mail: ambrosec@medimmune.com


No publications provided


Responsible Party: Maria Allende, M.D., MedImmune Inc.
ClinicalTrials.gov Identifier: NCT00461981     History of Changes
Other Study ID Numbers: MI-CP128
Study First Received: April 16, 2007
Results First Received: May 29, 2009
Last Updated: January 12, 2010
Health Authority: United States: Food and Drug Administration