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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
History of Changes
  Purpose
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.

Condition Intervention Phase
Influenza Vaccine
 Biological: TIV, Trivalent Inactivated Influenza Virus Vaccine
Biological: FluMist, Influenza Virus Vaccine Live
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

MedlinePlus related topics: Flu Flu Shot
U.S. FDA Resources

Further study details as provided by MedImmune LLC:

Primary Outcome Measures:
  • 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 ]
Enrollment: 101
Study Start Date: May 2007
Study Completion Date: February 2008
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FluMist, Influenza Virus Vaccine Live
FluMist, Influenza Virus Vaccine Live, Intranasal
 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
Active Comparator: TIV, Trivalent Inactivated Influenza Virus Vaccine
TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular
 Biological: TIV, Trivalent Inactivated Influenza Virus Vaccine
0.25 mL will be administered intramuscularly for each of two doses

Detailed Description:

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.

  Eligibility
Ages Eligible for Study:   12 Months to 35 Months   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00461981

Locations
United States, Arkansas
Harvey Pediatrics
Jonesboro, Arkansas, United States, 73401
Arkansas Pediatric Clinic
Little Rock, Arkansas, United States, 72205
United States, California
NuLife Clinical Research
Anaheim, California, United States, 92805
United States, Florida
Palm Beach Research Center
West Palm Beach, Florida, United States, 33409
United States, Kentucky
Central Kentucky Research Associates
Lexington, Kentucky, United States, 40509
Peak Medical Research, LLC
Owensboro, Kentucky, United States, 42303
United States, Louisiana
Benchmark Research
Metairie, Louisiana, United States, 70006
United States, Nebraska
Meridian Clinical Research, LLC
Omaha, Nebraska, United States, 68134
United States, Nevada
Henderson Pediatrics
Henderson, Nevada, United States, 89015
United States, New York
Regional Clinical Research, Inc.
Endwell, New York, United States, 13760
United States, Ohio
Dayton Clinical Research
Dayton, Ohio, United States, 45406
Northeast Cincinnati Pediatric Asso., Inc.
Mason, Ohio, United States, 45040
United States, Texas
Celia Reyes-Acuna, M.D.
Corpus Christi, Texas, United States, 78414
Allergy Immunology Research Center of North Texas
Dallas, Texas, United States, 75230
Healthcare Discoveries, Inc.
San Antonio, Texas, United States, 78209
United States, Utah
Wee Care Pediatrics
Layton, Utah, United States, 84041
Bear Care Pediatrics
Ogden, Utah, United States, 84405
United States, Virginia
Advanced Pediatrics
Vienna, Virginia, United States, 22180
Pediatrics at the Beach
Virginia Beach, Virginia, United States, 23454
Sponsors and Collaborators
MedImmune LLC
Investigators
Study Director: Maria Allende, M.D. MedImmune LLC
  More Information

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

Keywords provided by MedImmune LLC:
Live, attenuated influenza virus vaccine (LAIV)
Trivalent inactivated influenza virus vaccine (TIV)
FluMist

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
 Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 27, 2016