A Study to Evaluate the Immunogenicity of Quadrivalent LAIV (MEDI8662) in Adults 18 to 49 Years of Age (MI-CP206)
This study has been completed.
Sponsor:
MedImmune LLC
Information provided by:
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT00952705
First received: August 3, 2009
Last updated: December 9, 2011
Last verified: December 2011
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Purpose
The purpose of this study was to show that quadrivalent live attenuated influenza vaccine (Q/LAIV-BFS; MEDI8662) was at least as immunogenic as two different forms of the commercial vaccine, FluMist, by comparing the strain-specific antibody levels in the blood.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy or Stable Underlying Chronic Medical Condition |
Biological: Q/LAIV-BFS (MEDI8662) Biological: FluMist/B/Yamagata Biological: FluMist/B/Victoria |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | A Randomized, Partially Blind Active Controlled Study to Evaluate the Immunogenicity of MEDI8662 in Adults 18 to 49 Years of Age |
Resource links provided by NLM:
MedlinePlus related topics:
Flu
Drug Information available for:
Influenza Vaccines
U.S. FDA Resources
Further study details as provided by MedImmune LLC:
Primary Outcome Measures:
- The Post Dose Strain-specific Serum Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMTs) in the Q/LAIV-BFS (MEDI8662) Arm as Compared to Those in the Combined Flumist Arms (All Flumist Group). [ Time Frame: Day 28 to 35 ] [ Designated as safety issue: No ]Noninferior immune response was assessed by evaluating the upper bound of the 2-sided 95% confidence intervals (CIs) for the ratios of strain-specific HAI GMTs for the specified comparisons. The GMT ratio = GMT in comparator (All FluMist group) divided by the GMT in the Q/LAIV-BFS arm.
Secondary Outcome Measures:
- The Percentage of Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the A/H1N1 and A/H3N2 Strains in All Participants, Regardless of Baseline Serostatus. [ Time Frame: Day 0 and Day 28-35 ] [ Designated as safety issue: No ]Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. The comparators for seroresponse to the A/H1N1 and A/H3N2 strains were participants in the All FluMist group (combined data for both FluMist arms).
- The Percentage of Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the B/Yamagata Strain in All Participants, Regardless of Baseline Serostatus. [ Time Frame: Day 0 and Day 28-35 ] [ Designated as safety issue: No ]Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. The comparator for seroresponse to the B/Yamagata strain was participants in the FluMist/B/Yamagata arm.
- The Percentage of Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the B/Victoria Strain in All Participants, Regardless of Baseline Serostatus. [ Time Frame: Day 0 and Day 28-35 ] [ Designated as safety issue: No ]Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. The comparator for seroresponse to the B/Victoria strain was participants in the FluMist/B/Victoria arm.
- The Percentage of Serosusceptible Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the A/H1N1 Strain. [ Time Frame: Day 0 and Day 28-35 ] [ Designated as safety issue: No ]Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. Participants with a baseline HAI titer ≤ 8 were considered to be serosusceptible for that strain. The comparator for seroresponse to the A/H1N1 strain was participants in the All FluMist group (combined data for both FluMist arms).
- The Percentage of Serosusceptible Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the A/H3N2 Strain. [ Time Frame: Day 0 and Day 28-35 ] [ Designated as safety issue: No ]Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. Participants with a baseline HAI titer ≤ 8 were considered to be serosusceptible for that strain. The comparator for seroresponse to the A/H3N2 strain was participants in the All FluMist group (combined data for both FluMist arms).
- The Percentage of Serosusceptible Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the B/Yamagata Strain. [ Time Frame: Day 0 and Day 28-35 ] [ Designated as safety issue: No ]Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. Participants with a baseline HAI titer ≤ 8 were considered to be serosusceptible for that strain. The comparator for seroresponse to the B/Yamagata strain was participants in the FluMist/B/Yamagata arm.
- The Percentage of Serosusceptible Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the B/Victoria Strain. [ Time Frame: Day 0 and Day 28-35 ] [ Designated as safety issue: No ]Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. Participants with a baseline HAI titer ≤ 8 were considered to be serosusceptible for that strain. The comparator for seroresponse to the B/Victoria strain was participants in the FluMist/B/Victoria arm.
- The Percentage of Seropositive Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the A/H1N1 Strain. [ Time Frame: Day 0 and Day 28-35 ] [ Designated as safety issue: No ]Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. Participants with a baseline HAI titer > 8 were considered to be seropositive for that strain. The comparator for seroresponse to the A/H1N1 strain was participants in the All FluMist group (combined data for both FluMist arms).
- The Percentage of Seropositive Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the A/H3N2 Strain. [ Time Frame: Day 0 and Day 28-35 ] [ Designated as safety issue: No ]Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. Participants with a baseline HAI titer > 8 were considered to be seropositive for that strain. The comparator for seroresponse to the A/H3N2 strain was participants in the All FluMist group (combined data for both FluMist arms).
- The Percentage of Seropositive Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the B/Yamagata Strain. [ Time Frame: Day 0 and Day 28-35 ] [ Designated as safety issue: No ]Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. Participants with a baseline HAI titer > 8 were considered to be seropositive for that strain. The comparator for seroresponse to the B/Yamagata strain was participants in the FluMist/B/Yamagata arm.
- The Percentage of Seropositive Subjects Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the B/Victoria Strain. [ Time Frame: Day 0 and Day 28-35 ] [ Designated as safety issue: No ]Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. Participants with a baseline HAI titer > 8 were considered to be seropositive for that strain. The comparator for seroresponse to the B/Victoria strain was participants in the FluMist/B/Victoria arm.
- The Percentage of Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the A/H1N1 and A/H3N2 Strains in All Participants, Regardless of Baseline Serostatus. [ Time Frame: Day 28-35 ] [ Designated as safety issue: No ]The comparators to the A/H1N1 and A/H3N2 strains were participants in the All FluMist group (combined data for both FluMist arms).
- The Percentage of Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the B/Yamagata Strain in All Participants, Regardless of Baseline Serostatus. [ Time Frame: Day 28-35 ] [ Designated as safety issue: No ]The comparator for the B/Yamagata strain was participants in the FluMist/B/Yamagata arm.
- The Percentage of Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the B/Victoria Strain in All Participants, Regardless of Baseline Serostatus. [ Time Frame: Day 28-35 ] [ Designated as safety issue: No ]The comparator for the B/Victoria strain was participants in the FluMist/B/Victoria arm.
- The Percentage of Serosusceptible Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the A/H1N1 Strain. [ Time Frame: Day 28-35 ] [ Designated as safety issue: No ]Participants with a baseline HAI titer ≤ 8 were considered to be serosusceptible for that strain. The comparator for the A/H1N1 strain was participants in the All FluMist group (combined data for both FluMist arms).
- The Percentage of Serosusceptible Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the A/H3N2 Strain. [ Time Frame: Day 28-35 ] [ Designated as safety issue: No ]Participants with a baseline HAI titer ≤ 8 were considered to be serosusceptible for that strain. The comparator for the A/H3N2 strain was participants in the All FluMist group (combined data for both FluMist arms).
- The Percentage of Serosusceptible Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the B/Yamagata Strain. [ Time Frame: Day 28-35 ] [ Designated as safety issue: No ]Subjects with a baseline HAI titer ≤ 8 were considered to be serosusceptible for that strain. The comparator for the B/Yamagata strain was participants in the FluMist/B/Yamagata arm.
- The Percentage of Serosusceptible Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the B/Victoria Strain. [ Time Frame: Day 28-35 ] [ Designated as safety issue: No ]Participants with a baseline HAI titer ≤ 8 were considered to be serosusceptible for that strain. The comparator for the B/Victoria strain was participants in the FluMist/B/Victoria arm.
- The Percentage of Seropositive Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the A/H1N1 Strain. [ Time Frame: Day 28-35 ] [ Designated as safety issue: No ]Participants with a baseline HAI titer > 8 were considered to be seropositive for that strain. The comparator for the A/H1N1 strain was participants in the All FluMist group (combined data for both FluMist arms).
- The Percentage of Seropositive Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the A/H3N2 Strain. [ Time Frame: Day 28-35 ] [ Designated as safety issue: No ]Participants with a baseline HAI titer > 8 were considered to be seropositive for that strain. The comparator for the A/H3N2 strain was participants in the All FluMist group (combined data for both FluMist arms).
- The Percentage of Seropositive Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the B/Yamagata Strain. [ Time Frame: Day 28-35 ] [ Designated as safety issue: No ]Participants with a baseline HAI titer > 8 were considered to be seropositive for that strain. The comparator for the B/Yamagata strain was participants in the FluMist/B/Yamagata arm.
- The Percentage of Seropositive Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the B/Victoria Strain. [ Time Frame: Day 28-35 ] [ Designated as safety issue: No ]Participants with a baseline HAI titer > 8 were considered to be seropositive for that strain. The comparator for the B/Victoria strain was participants in the FluMist/B/Victoria arm.
- The Percentage of Participants Experiencing Each Solicited Symptom From Administration of Investigational Product Through 14 Days Post Dose [ Time Frame: Days 0-14 post dose ] [ Designated as safety issue: Yes ]
- The Percentage of Participants Reporting Any Adverse Event From Administration of Investigational Product Through 28 Days Post Dose [ Time Frame: Days 0-28 post dose ] [ Designated as safety issue: Yes ]
- The Percentage of Participants Reporting Any Serious Adverse Event From Administration of Investigational Product Through 28 Days Post Dose [ Time Frame: Days 0-28 post dose ] [ Designated as safety issue: Yes ]
- The Percentage of Participants Reporting Any Serious Adverse Event From Administration of Investigational Product Through 180 Days Post Dose [ Time Frame: Days 0-180 post dose ] [ Designated as safety issue: Yes ]
- The Percentage of Participants Reporting New Onset Chronic Diseases From Administration of Investigational Product Through 180 Days Post Dose [ Time Frame: Days 0-180 post dose ] [ Designated as safety issue: Yes ]
| Enrollment: | 1800 |
| Study Start Date: | August 2009 |
| Study Completion Date: | March 2010 |
| Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Q/LAIV-BFS (MEDI8662)
Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
|
Biological: Q/LAIV-BFS (MEDI8662)
A single dose of Q/LAIV-BFS delivered using the BFS delivery system (0.2 mL) on Day 0.
|
|
Active Comparator: FluMist/B/Yamagata
FluMist/B/Yamagata was administered intranasally using a Becton Dickinson Accuspray™ device. A total volume of 0.2 mL was administered intranasally (approximately 0.1 mL into each nostril). Each dose contained 10^7.0 ± 0.5 FFU of each of 3 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), and B/Yamagata (B/Florida/4/2006)
|
Biological: FluMist/B/Yamagata
FluMist/B/Yamagata - 0.2 mL dose at Day 0
|
|
Active Comparator: FluMist/B/Victoria
FluMist/B/Victoria was administered intranasally using a BD Accuspray™ device. A total volume of 0.2 mL was administered intranasally (approximately 0.1 mL into each nostril). Each dose contained 10^7.0 ± 0.5 FFU of each of 3 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), and B/Victoria (B/Malaysia/2506/2004).
|
Biological: FluMist/B/Victoria
FluMist/B/Victoria - 0.2 mL dose at Day 0
|
Detailed Description:
The primary objective of this study was to determine the immunologic noninferiority of MEDI8662, a quadrivalent live attenuated influenza vaccine (Q/LAIV) (delivered intranasally using the blow-fill-seal [BFS] delivery system) (Q/LAIV-BFS) to two trivalent formulations of licensed FluMist (delivered intranasally using the Becton Dickinson [BD] Accuspray™ device) by comparing the strain-specific geometric mean titers (GMTs) post dosing.
Eligibility| Ages Eligible for Study: | 18 Years to 49 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Male or female, age 18 through 49 years, inclusive (reached their 18th year birthday but not yet reached their 50th year birthday) at the time of randomization
- Females of child-bearing potential, must have used an effective method of avoiding pregnancy for 30 days prior to the first dose of investigational product, and must have agreed to continue using such precautions for 60 days after the dose of investigational product. In addition, the participant must also have had a negative urine or blood pregnancy test at screening and, if screening and Day 0 do not occur on the same day, on the day of vaccination prior to randomization.
- Healthy by medical history and physical examination OR presence of stable underlying chronic medical condition for which hospitalization had not been required in the previous year
Exclusion Criteria:
- Acute illness or evidence of significant active infection at randomization
- Fever greater than or equal to 100.4 degrees F (38°C) at randomization
- History of asthma
- Any drug therapy from 15 days prior to randomization or expected drug therapy through 30 days post dose with the exception of contraceptives; topical corticosteroids or antifungals for uncomplicated dermatitis; chronic medications (including those taken on an as-needed basis) that were well tolerated and were not initiated and/or did not have a dosage change within 90 days of randomization
- Previous medical history or evidence of an intercurrent illness that may have compromised the safety of the participant in the study
- Current or expected receipt of immunosuppressive medications (inhaled and topical corticosteroids and topical calcineurin inhibitors were permitted) within a 30-day window around the dose
- Receipt of immunoglobulin or blood products within 90 days before randomization into the study or expected receipt during study participation
- Receipt of any investigational drug therapy within 30 days prior to randomization or planned receipt of any investigational drug therapy through 30 days after dosing of investigational product (use of licensed agents for indications not listed in the package insert were permitted)
- Receipt of any nonstudy vaccine within 30 days prior to randomization or planned receipt of nonstudy vaccine through 30 days after dosing
- Receipt of any influenza vaccine (investigational or licensed) in 2009 prior to randomization or anticipated receipt prior to the collection of the post-dose immunogenicity blood sample for this study
- Any known immunosuppressive condition or immune deficiency disease including known or suspected infection with human immunodeficiency virus (HIV)
- History of allergic disease or reactions likely to be exacerbated by any component of Q/LAIV-BFS including allergy to eggs, egg proteins, gentamicin, or gelatin, or serious, life threatening, or severe reactions to previous influenza vaccinations
- History of Guillain-Barré syndrome
- Use of antiviral agents with activity against influenza virus (including amantadine, rimantadine, oseltamivir and zanamivir) within 30 days prior to receipt of investigational product or anticipated use within 30 days after receipt of investigational product
- Known or suspected mitochondrial encephalomyopathy
- Pregnant or lactating female
- Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of participant safety or study results
- Participant, legal guardian, or immediate family member of participant who was an employee of the clinical study site or who was otherwise involved with the conduct of the study
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00952705
Locations
| United States, Alabama | |
| Coastal Clinical Research, Inc. | |
| Mobile, Alabama, United States, 36608 | |
| United States, California | |
| Benchmark Research | |
| Sacramento, California, United States, 95816 | |
| California Research Foundation | |
| San Diego, California, United States, 92103-6204 | |
| Benchmark Research | |
| San Francisco, California, United States, 94102 | |
| United States, Florida | |
| Tampa Bay Medical Research, Inc. | |
| Clearwater, Florida, United States, 33761 | |
| Avail Clinical Research, LLC | |
| Deland, Florida, United States, 32720 | |
| Miami Research Associates | |
| Miami, Florida, United States, 33143 | |
| United States, Georgia | |
| Clinical Research Atlanta | |
| Stockbridge, Georgia, United States, 30281 | |
| United States, Kansas | |
| Johnson County Clin-Trials | |
| Lenexa, Kansas, United States, 66219 | |
| Vince and Associates Clinical Research | |
| Overland Park, Kansas, United States, 66212 | |
| United States, Louisiana | |
| Benchmark Research | |
| Metairie, Louisiana, United States, 70006 | |
| United States, Missouri | |
| Sundance Clinical Research | |
| St. Louis, Missouri, United States, 63141 | |
| United States, Nebraska | |
| Meridian Clinical Research, LLC | |
| Omaha, Nebraska, United States, 68134 | |
| United States, New York | |
| Regional Clinical Research | |
| Endwell, New York, United States, 13760 | |
| Rochester Clinical Research Inc. | |
| Rochester, New York, United States, 14609 | |
| United States, South Carolina | |
| Palmetto Medical Research | |
| Mt. Pleasant, SC, South Carolina, United States, 29464 | |
| United States, Texas | |
| Benchmark Research Austin | |
| Austin, Texas, United States, 78705 | |
| Benchmark Research Ft. Worth | |
| Ft. Worth, Texas, United States, 76135 | |
Sponsors and Collaborators
MedImmune LLC
Investigators
| Study Director: | Joseph Sliman, M.D., MPH | MedImmune LLC |
More Information
Additional Information:
No publications provided
| Responsible Party: | J. A. Sliman, MD, MPH, MedImmune, LLC |
| ClinicalTrials.gov Identifier: | NCT00952705 History of Changes |
| Other Study ID Numbers: | MI-CP206 |
| Study First Received: | August 3, 2009 |
| Results First Received: | June 28, 2011 |
| Last Updated: | December 9, 2011 |
| Health Authority: | United States: Food and Drug Administration |
ClinicalTrials.gov processed this record on June 17, 2013