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A Phase 2 Study to Evaluate Immune Responses of FluMist®
This study has been completed.
Sponsor:
MedImmune LLC
Information provided by:
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT00461981
First received: April 16, 2007
Last updated: January 12, 2010
Last verified: January 2010
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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 Intervention Model: Single Group Assignment Masking: None (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:
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) ]
- 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) ]
- 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) ]
- 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) ]
- 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) ]
- 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) ]
- 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) ]
- 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) ]
- 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) ]
- 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) ]
- 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) ]
- 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) ]
- 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) ]
- 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) ]
- 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) ]
- 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) ]
- 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) ]
- 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) ]
- 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) ]
- 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) ]
- 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) ]
- 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) ]
- 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) ]
- 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) ]
- 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) ]
- 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) ]
- 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) ]
- 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) ]
- 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) ]
- 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) ]
- 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) ]
- 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) ]
- 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) ]
- 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) ]
- 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) ]
- 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) ]
- 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) ]
- 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) ]
- 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) ]
- 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) ]
- 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) ]
- 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) ]
- 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) ]
- 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) ]
- 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) ]
- 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) ]
- 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) ]
- 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) ]
- Immunogenicity Response by B-cell IgG and IgA ELISPOT Assay [ Time Frame: Post Dose 1 (7 to 10 days post Dose 1) ]
- Immunogenicity Response by B-cell IgG and IgA ELISPOT Assay [ Time Frame: Post Dose 2 (7 to 10 days post Dose 2) ]
- 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) ]
- 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) ]
- Distribution of Interferon (IFN)-Alpha/Beta Gene Signature Scores Among All Subjects [ Time Frame: Post Dose 1 (28 to 42 days post Dose 1) ]
| 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) |
| Sexes Eligible for Study: | All |
| 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
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 |
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 August 17, 2017