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

April 16, 2007
January 12, 2010
May 2007
December 2007   (final data collection date for primary outcome measure)
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • Immunogenicity Response by B-cell IgG and IgA ELISPOT Assay [ Time Frame: Post Dose 1 (7 to 10 days post Dose 1) ] [ Designated as safety issue: No ]
  • Immunogenicity Response by B-cell IgG and IgA ELISPOT Assay [ Time Frame: Post Dose 2 (7 to 10 days post Dose 2) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • Distribution of Interferon (IFN)-Alpha/Beta Gene Signature Scores Among All Subjects [ Time Frame: Post Dose 1 (28 to 42 days post Dose 1) ] [ Designated as safety issue: No ]
  • The strain-specific HAI seroconversion rates (≥4-fold increase) among baseline seronegative subjects (HAI titer ≤1:4), by dose number
  • Transcriptional analysis of blood samples from baseline seronegative subjects and from all subjects regardless of baseline serostatus, by dose number
  • Cellular immune response as measured by ELISPOT and other T-cell or B-cell marker assays in baseline seronegative subjects and in all subjects regardless of baseline serostatus, by dose number
  • The strain-specific HAI GMT in baseline seronegative subjects, by dose number
  • The strain-specific microneutralization GMT in baseline seronegative subjects, by dose number
  • The strain-specific microneutralization seroconversion rates among baseline seronegative subjects, by dose number
Complete list of historical versions of study NCT00461981 on ClinicalTrials.gov Archive Site
Not Provided
  • The safety endpoints for the study include
  • AEs, SAEs, and Significant New Medical Conditions (SNMCs)for all subjects
Not Provided
Not Provided
 
A Phase 2 Study to Evaluate Immune Responses of FluMist®
A Phase 2, Prospective, Randomized, Open-Label Study to Evaluate the Immune Responses of FluMist® Compared With Trivalent Inactivated Vaccine (TIV) in Children 12 to <36 Months of Age

The primary objective of this study is to describe the level of serum antibody and cellular immune responses conferred by FluMist and TIV against influenza virus strains.

The primary objective of this study is to describe the level of serum antibody and cellular immune responses conferred by FluMist and TIV against antigenically matched and antigenically mismatched influenza virus strains.

The secondary objective of this study is to describe the safety of FluMist and TIV in subjects 12 to <36 months of age.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Influenza Vaccine
  • Biological: TIV, Trivalent Inactivated Influenza Virus Vaccine
    0.25 mL will be administered intramuscularly for each of two doses
  • Biological: FluMist, Influenza Virus Vaccine Live
    0.5 mL will be administered intranasally (approximately 0.25 mL into each nostril) for each of two doses
  • Experimental: FluMist, Influenza Virus Vaccine Live
    FluMist, Influenza Virus Vaccine Live, Intranasal
    Intervention: Biological: FluMist, Influenza Virus Vaccine Live
  • Active Comparator: TIV, Trivalent Inactivated Influenza Virus Vaccine
    TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular
    Intervention: Biological: TIV, Trivalent Inactivated Influenza Virus Vaccine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
101
February 2008
December 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female aged 12 to <36 months (reached their 1st year but not yet reached their 3rd year birthday) at the time of randomization
  • Written informed consent and HIPAA authorization obtained from the subject's legal representative
  • Ability of the subject's legal representative to understand and comply with the requirements of the study
  • Subject's legal representative available by telephone
  • Ability to complete follow-up period of 180 days after final study vaccination as required by the protocol

Exclusion Criteria:

  • History of hypersensitivity to any component of FluMist or TIV, including egg or egg products
  • History of hypersensitivity to gentamicin
  • Any known immunosuppressive condition or immune deficiency disease (including HIV infection), or ongoing receipt of any immunosuppressive therapy
  • Household contact who is immunocompromised (participants should also avoid close contact with immunocompromised individuals for at least 21 days after each study vaccination)
  • History of Guillain-Barré syndrome
  • Any prior history of wheezing or asthma
  • Acute febrile (≥100.0°F oral or equivalent) and/or clinically significant respiratory illness (e.g., cough or sore throat) within 72 hours prior to either study vaccination
  • Use of aspirin or aspirin-containing products within the 30 days prior to randomization, or expected receipt through 180 days after final study vaccination
  • Receipt of any prior influenza vaccine
  • Use of anti-influenza medications (including amantadine, rimantadine, oseltamivir, and zanamivir) within 14 days prior to randomization, or expected receipt through 35 days after final study vaccination
  • Administration of any live virus vaccine, other than measles, mumps, rubella, and varicella-containing vaccine(s), within 30 days prior to randomization, or expected receipt through 30 days after final study vaccination
  • Administration of any inactivated (i.e., non-live) vaccine within 14 days prior to randomization, or expected receipt within 14 days before or 14 days after either study vaccination
  • Receipt of any investigational agent within 30 days prior to randomization, or expected receipt through 180 days after final study vaccination (use of licensed agents for indications not listed in the package insert is permitted)
  • Receipt of any blood product within 90 days prior to randomization, or expected receipt through 35 days after final study vaccination
  • Family member or household contact who is an employee of the research center or otherwise involved with the conduct of the study
  • Any condition that in the opinion of the investigator would interfere with evaluation of the vaccine or interpretation of study results
Both
12 Months to 35 Months
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00461981
MI-CP128
Yes
Maria Allende, M.D., MedImmune Inc.
MedImmune LLC
Not Provided
Study Director: Maria Allende, M.D. MedImmune LLC
MedImmune LLC
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP