A Study to Evaluate the Immunogenicity of Quadrivalent LAIV (MEDI8662) in Adults 18 to 49 Years of Age
NCT ID: NCT00952705
Last Updated: 2018-05-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1800 participants
INTERVENTIONAL
2009-08-31
2010-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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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).
Q/LAIV-BFS (MEDI8662)
A single dose of Q/LAIV-BFS delivered using the BFS delivery system (0.2 mL) on Day 0.
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)
FluMist/B/Yamagata
FluMist/B/Yamagata - 0.2 mL dose at Day 0
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).
FluMist/B/Victoria
FluMist/B/Victoria - 0.2 mL dose at Day 0
Interventions
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Q/LAIV-BFS (MEDI8662)
A single dose of Q/LAIV-BFS delivered using the BFS delivery system (0.2 mL) on Day 0.
FluMist/B/Yamagata
FluMist/B/Yamagata - 0.2 mL dose at Day 0
FluMist/B/Victoria
FluMist/B/Victoria - 0.2 mL dose at Day 0
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
49 Years
ALL
Yes
Sponsors
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MedImmune LLC
INDUSTRY
Responsible Party
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MedImmune, LLC
Principal Investigators
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Joseph Sliman, M.D., MPH
Role: STUDY_DIRECTOR
MedImmune LLC
Locations
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Coastal Clinical Research, Inc.
Mobile, Alabama, United States
Benchmark Research
Sacramento, California, United States
California Research Foundation
San Diego, California, United States
Benchmark Research
San Francisco, California, United States
Tampa Bay Medical Research, Inc.
Clearwater, Florida, United States
Avail Clinical Research, LLC
DeLand, Florida, United States
Miami Research Associates
Miami, Florida, United States
Clinical Research Atlanta
Stockbridge, Georgia, United States
Johnson County Clin-Trials
Lenexa, Kansas, United States
Vince and Associates Clinical Research
Overland Park, Kansas, United States
Benchmark Research
Metairie, Louisiana, United States
Sundance Clinical Research
St Louis, Missouri, United States
Meridian Clinical Research, LLC
Omaha, Nebraska, United States
Regional Clinical Research
Endwell, New York, United States
Rochester Clinical Research Inc.
Rochester, New York, United States
Palmetto Medical Research
Mt. Pleasant, South Carolina, United States
Benchmark Research Austin
Austin, Texas, United States
Benchmark Research Ft. Worth
Fort Worth, Texas, United States
Countries
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References
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Sheldon EA, Jeanfreau R, Sliman JA, Charenkavanich S, Rousculp MD, Dubovsky F, Mallory RM. Immunogenicity of a quadrivalent Ann Arbor strain live attenuated influenza vaccine delivered using a blow-fill-seal device in adults: a randomized, active-controlled study*. Influenza Other Respir Viruses. 2013 Nov;7(6):1142-50. doi: 10.1111/irv.12027. Epub 2012 Oct 14.
Other Identifiers
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MI-CP206
Identifier Type: -
Identifier Source: org_study_id
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