Clinical trial NCT00461981: A Phase 2 Study to Evaluate Immune Responses of FluMist®
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Influenza Vaccine
Keywords: Live, attenuated influenza virus vaccine (LAIV)
Trivalent inactivated influenza virus vaccine (TIV)
FluMist
Lead sponsor: MedImmune LLC
Sponsor class: INDUSTRY
First posted: 2007-04-18
Enrollment: 101
Sex: ALL
Minimum age (years): 12
Maximum age (years): 35
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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 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

Primary outcomes:
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
timeFrame: Post Dose 1 (28 to 42 days post Dose 1)
measure: 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
timeFrame: Post Dose 2 (28 to 35 days post Dose 2)
measure: 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
timeFrame: Post Dose 1 (28 to 42 days post Dose 1)
measure: 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
timeFrame: Post Dose 2 (28 to 35 days post Dose 2)
measure: Percentage of Subjects With Antigenically Matched Strain-specific Hemagglutination Inhibition (HAI)Seroconversion Following the First Dose - H3N2 /wt A/Wisconsin/67/05 Influenza Strain
timeFrame: Post Dose 1 (28 to 42 days post Dose 1)
measure: Percentage of Subjects With Antigenically Matched Strain-specific Hemagglutination Inhibition (HAI) Seroconversion Following the Second Dose - H3N2 /wt A/Wisconsin/67/05 Influenza Strain
timeFrame: Post Dose 2 (28 to 35 days post Dose 2)
measure: Percentage of Subjects With Antigenically Matched Strain-specific Hemagglutination Inhibition (HAI) Seroconversion Following the First Dose - B /wt B/Malaysia/2506/04 Influenza Strain
timeFrame: Post Dose 1 (28 to 42 days post Dose 1)
measure: Percentage of Subjects With Antigenically Matched Strain-specific Hemagglutination Inhibition (HAI) Seroconversion Following the Second Dose - B /wt B/Malaysia/2506/04 Influenza Strain
timeFrame: Post Dose 2 (28 to 35 days post Dose 2)
measure: 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
timeFrame: Post Dose 1 (28 to 42 days post Dose 1)
measure: 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
timeFrame: Post Dose 2 (28 to 35 days post Dose 2)
measure: Percentage of Subjects With Antigenically Mismatched Strain-specific Hemagglutination Inhibition (HAI) Seroconversion Following the First Dose - H3N2 /wt A/Brisbane/10/2007 Influenza Strain
timeFrame: Post Dose 1 (28 to 42 days post Dose 1)
measure: Percentage of Subjects With Antigenically Mismatched Strain-specific Hemagglutination Inhibition (HAI) Seroconversion Following the Second Dose - H3N2 /wt A/Brisbane/10/2007 Influenza Strain
timeFrame: Post Dose 2 (28 to 35 days post Dose 2)
measure: Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - H1N1 /wt A/New Caledonia/20/99 Influenza Strain
timeFrame: Post Dose 1 (28 to 42 days post Dose 1)
measure: Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - H1N1 /wt A/New Caledonia/20/99 Influenza Strain
timeFrame: Post Dose 2 (28 to 35 days post Dose 2)
measure: Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - H1N1 /ca A/New Caledonia/20/99 Influenza Strain
timeFrame: Post Dose 1 (28 to 42 days post Dose 1)
measure: Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - H1N1 /ca A/New Caledonia/20/99 Influenza Strain
timeFrame: Post Dose 2 (28 to 35 days post Dose 2)
measure: Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - H3N2 /wt A/Wisconsin/67/05 Influenza Strain
timeFrame: Post Dose 1 (28 to 42 days post Dose 1)
measure: Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - H3N2 /wt A/Wisconsin/67/05 Influenza Strain
timeFrame: Post Dose 2 (28 to 35 days post Dose 2)
measure: Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - B /wt B/Malaysia/2506/04 Influenza Strain
timeFrame: Post Dose 1 (28 to 42 days post Dose 1)
measure: Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - B /wt B/Malaysia/2506/04 Influenza Strain
timeFrame: Post Dose 2 (28 to 35 days post Dose 2)
measure: Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - H1N1 /wt A/Solomon Island/3/06 Influenza Strain
timeFrame: Post Dose 1 (28 to 42 days post Dose 1)
measure: Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - H1N1 /wt A/Solomon Island/3/06 Influenza Strain
timeFrame: Post Dose 2 (28 to 35 days post Dose 2)
measure: Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - H3N2 /wt A/Brisbane/10/2007 Influenza Strain
timeFrame: Post Dose 1 (28 to 42 days post Dose 1)
measure: Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - H3N2 /wt A/Brisbane/10/2007 Influenza Strain
timeFrame: Post Dose 2 (28 to 35 days post Dose 2)
measure: Percentage of Subjects With Antigenically Matched Strain-specific Microneutralization Seroconversion Following the First Dose - H1N1 /wt A/New Caledonia/20/99 Influenza Strain
timeFrame: Post Dose 1 (28 to 42 days post Dose 1)
measure: Percentage of Subjects With Antigenically Matched Strain-specific Microneutralization Seroconversion Following the Second Dose - H1N1 /wt A/New Caledonia/20/99 Influenza Strain
timeFrame: Post Dose 2 (28 to 35 days post Dose 2)
measure: Percentage of Subjects With Antigenically Matched Strain-specific Microneutralization Seroconversion Following the First Dose - H1N1 /ca A/New Caledonia/20/99 Influenza Strain
timeFrame: Post Dose 1 (28 to 42 days post Dose 1)
measure: Percentage of Subjects With Antigenically Matched Strain-specific Microneutralization Seroconversion Following the Second Dose - H1N1 /ca A/New Caledonia/20/99 Influenza Strain
timeFrame: Post Dose 2 (28 to 35 days post Dose 2)
measure: Percentage of Subjects With Antigenically Matched Strain-specific Microneutralization Seroconversion Following the First Dose - H3N2 /wt A/Wisconsin/67/05 Influenza Strain
timeFrame: Post Dose 1 (28 to 42 days post Dose 1)
measure: Percentage of Subjects With Antigenically Matched Strain-specific Microneutralization Seroconversion Following the Second Dose - H3N2 /wt A/Wisconsin/67/05 Influenza Strain
timeFrame: Post Dose 2 (28 to 35 days post Dose 2)
measure: Percentage of Subjects With Antigenically Matched Strain-specific Microneutralization Seroconversion Following the First Dose - B /wt B/Malaysia/2506/04 Influenza Strain
timeFrame: Post Dose 1 (28 to 42 days post Dose 1)
measure: Percentage of Subjects With Antigenically Matched Strain-specific Microneutralization Seroconversion Following the Second Dose - B /wt B/Malaysia/2506/04 Influenza Strain
timeFrame: Post Dose 2 (28 to 35 days post Dose 2)
measure: Percentage of Subjects With Antigenically Mismatched Strain-specific Microneutralization Seroconversion Following the First Dose - H1N1 /wt A/Solomon Island/3/06 Influenza Strain
timeFrame: Post Dose 1 (28 to 42 days post Dose 1)
measure: Percentage of Subjects With Antigenically Mismatched Strain-specific Microneutralization Seroconversion Following the Second Dose - H1N1 /wt A/Solomon Island/3/06 Influenza Strain
timeFrame: Post Dose 2 (28 to 35 days post Dose 2)
measure: Percentage of Subjects With Antigenically Mismatched Strain-specific Microneutralization Seroconversion Following the First Dose - H3N2 /wt A/Brisbane/10/2007 Influenza Strain
timeFrame: Post Dose 1 (28 to 42 days post Dose 1)
measure: Percentage of Subjects With Antigenically Mismatched Strain-specific Microneutralization Seroconversion Following the Second Dose - H3N2 /wt A/Brisbane/10/2007 Influenza Strain
timeFrame: Post Dose 2 (28 to 35 days post Dose 2)
measure: Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - H1N1 /wt A/New Caledonia/20/99 Influenza Strain
timeFrame: Post Dose 1 (28 to 42 days post Dose 1)
measure: Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - H1N1 /wt A/New Caledonia/20/99 Influenza Strain
timeFrame: Post Dose 2 (28 to 35 days post Dose 2)
measure: Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - H1N1 /ca A/New Caledonia/20/99 Influenza Strain
timeFrame: Post Dose 1 (28 to 42 days post Dose 1)
measure: Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - H1N1 /ca A/New Caledonia/20/99 Influenza Strain
timeFrame: Post Dose 2 (28 to 35 days post Dose 2)
measure: Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - H3N2 /wt A/Wisconsin/67/05 Influenza Strain
timeFrame: Post Dose 1 (28 to 42 days post Dose 1)
measure: Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - H3N2 /wt A/Wisconsin/67/05 Influenza Strain
timeFrame: Post Dose 2 (28 to 35 days post Dose 2)
measure: Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - B /wt B/Malaysia/2506/04 Influenza Strain
timeFrame: Post Dose 1 (28 to 42 days post Dose 1)
measure: Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - H1N1 /wt A/Solomon Island/3/06 Influenza Strain
timeFrame: Post Dose 1 (28 to 42 days post Dose 1)
measure: Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - B /wt B/Malaysia/2506/04 Influenza Strain
timeFrame: Post Dose 2 (28 to 35 days post Dose 2)
measure: Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - H1N1 /wt A/Solomon Island/3/06 Influenza Strain
timeFrame: Post Dose 2 (28 to 35 days post Dose 2)
measure: Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - H3N2 /wt A/Brisbane/10/2007 Influenza Strain
timeFrame: Post Dose 1 (28 to 42 days post Dose 1)
measure: Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - H3N2 /wt A/Brisbane/10/2007 Influenza Strain
timeFrame: Post Dose 2 (28 to 35 days post Dose 2)
measure: Immunogenicity Response by B-cell IgG and IgA ELISPOT Assay
timeFrame: Post Dose 1 (7 to 10 days post Dose 1)
measure: Immunogenicity Response by B-cell IgG and IgA ELISPOT Assay
timeFrame: Post Dose 2 (7 to 10 days post Dose 2)
measure: 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
timeFrame: Post Dose 1 (28 to 42 days post Dose 1)
measure: Median Fold-Rises in the Number of Interferon-gamma Elispots Per 200,000 Peripheral Blood Mononuclear Cells (PBMCs) by T-cell Elispot Assay
timeFrame: Post Dose 2 (28 to 35 days post Dose 2)
measure: Distribution of Interferon (IFN)-Alpha/Beta Gene Signature Scores Among All Subjects
timeFrame: Post Dose 1 (28 to 42 days post Dose 1)
Secondary outcomes:
Other outcomes:
Locations:
city: Jonesboro
country: United States
facility: Harvey Pediatrics
state: Arkansas
city: Little Rock
country: United States
facility: Arkansas Pediatric Clinic
state: Arkansas
city: Anaheim
country: United States
facility: NuLife Clinical Research
state: California
city: West Palm Beach
country: United States
facility: Palm Beach Research Center
state: Florida
city: Lexington
country: United States
facility: Central Kentucky Research Associates
state: Kentucky
city: Owensboro
country: United States
facility: Peak Medical Research, LLC
state: Kentucky
city: Metairie
country: United States
facility: Benchmark Research
state: Louisiana
city: Omaha
country: United States
facility: Meridian Clinical Research, LLC
state: Nebraska
city: Henderson
country: United States
facility: Henderson Pediatrics
state: Nevada
city: Endwell
country: United States
facility: Regional Clinical Research, Inc.
state: New York
city: Dayton
country: United States
facility: Dayton Clinical Research
state: Ohio
city: Mason
country: United States
facility: Northeast Cincinnati Pediatric Asso., Inc.
state: Ohio
city: Corpus Christi
country: United States
facility: Celia Reyes-Acuna, M.D.
state: Texas
city: Dallas
country: United States
facility: Allergy Immunology Research Center of North Texas
state: Texas
city: San Antonio
country: United States
facility: Healthcare Discoveries, Inc.
state: Texas
city: Layton
country: United States
facility: Wee Care Pediatrics
state: Utah
city: Ogden
country: United States
facility: Bear Care Pediatrics
state: Utah
city: Vienna
country: United States
facility: Advanced Pediatrics
state: Virginia
city: Virginia Beach
country: United States
facility: Pediatrics at the Beach
state: Virginia
Study officials:
affiliation: MedImmune LLC
name: Maria Allende, M.D.
role: STUDY_DIRECTOR
References: