A Study to Evaluate the Immunogenicity of Quadrivalent LAIV in Adults 18 to 49 Years of Age
Information source: MedImmune LLC
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy or Stable Underlying Chronic Medical Condition
Intervention: Q/LAIV (MEDI3250) (Biological); FluMist/B/Yamagata (Biological); FluMist/B/Victoria (Biological)
Phase: Phase 2/Phase 3
Status: Completed
Sponsored by: MedImmune LLC Official(s) and/or principal investigator(s): Judith Falloon, M.D., Study Director, Affiliation: MedImmune LLC
Summary
The objective of this study was to show that quadrivalent live attenuated influenza vaccine
(Q/LAIV; MEDI3250) produced antibody levels similar to those produced by the commercial
vaccine, FluMist.
Clinical Details
Official title: A Randomized, Double-Blind, Active Controlled Study to Evaluate the Immunogenicity of MEDI3250 in Adults 18 to 49 Years of Age
Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: The 4 Post-dose Strain-specific Serum Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMT) in the Q/LAIV (MEDI3250) Arm Are Noninferior to Those in the Comparator FluMist Group.
Secondary outcome: The Number of Participants (Regardless of Serostatus) Within Each Treatment Arm Who Experience Strain-specific Seroresponse Post Dose.The Number of Serosusceptible Participants Within Each Treatment Arm Who Experience A/H1N1 Strain-specific Seroresponse Post Dose. The Number of Serosusceptible Participants Within Each Treatment Arm Who Experience A/H3N2 Strain-specific Seroresponse Post Dose. The Number of Serosusceptible Participants Within Each Treatment Arm Who Experience B/Yamagata Strain-specific Seroresponse Post Dose. The Number of Serosusceptible Participants Within Each Treatment Arm Who Experience B/Victoria Strain-specific Seroresponse Post Dose. The Number of Seropositive Participants Within Each Treatment Arm Who Experience A/H1N1 Strain-specific Seroresponse Post Dose. The Number of Seropositive Participants Within Each Treatment Arm Who Experience A/H3N2 Strain-specific Seroresponse Post Dose. The Number of Seropositive Participants Within Each Treatment Arm Who Experience B/Yamagata Strain-specific Seroresponse Post Dose. The Number of Seropositive Participants Within Each Treatment Arm Who Experience B/Victoria Strain-specific Seroresponse Post Dose. The Number of Participants (Regardless of Serostatus) Within Each Treatment Arm Who Achieved a Strain-specific HAI Antibody Titer ≥ 32 Post Dose. The Number of Serosusceptible Participants Within Each Treatment Arm Who Achieved a A/H1N1 Strain-specific HAI Antibody Titer ≥ 32 Post Dose. The Number of Serosusceptible Participants Within Each Treatment Arm Who Achieved a A/H3N2 Strain-specific HAI Antibody Titer ≥ 32 Post Dose. The Number of Serosusceptible Participants Within Each Treatment Arm Who Achieved a B/Yamagata Strain-specific HAI Antibody Titer ≥ 32 Post Dose. The Number of Serosusceptible Participants Within Each Treatment Arm Who Achieved a B/Victoria Strain-specific HAI Antibody Titer ≥ 32 Post Dose. The Number of Seropositive Participants Within Each Treatment Arm Who Achieved a A/H1N1 Strain-specific HAI Antibody Titer ≥ 32 Post Dose. The Number of Seropositive Participants Within Each Treatment Arm Who Achieved a A/H3N2 Strain-specific HAI Antibody Titer ≥ 32 Post Dose. The Number of Seropositive Participants Within Each Treatment Arm Who Achieved a B/Yamagata Strain-specific HAI Antibody Titer ≥ 32 Post Dose. The Number of Seropositive Participants Within Each Treatment Arm Who Achieved a B/Victoria Strain-specific HAI Antibody Titer ≥ 32 Post Dose. The Number of Participants Experiencing Each Solicited Symptom From Administration of Investigational Product Through 14 Days Post Vaccination The Number of Participants Reporting Any Adverse Event From Administration of Investigational Product Through 28 Days Post Vaccination Number of Participants Reporting Any Serious Adverse Event From Administration of Investigational Product Through 28 Days Post Vaccination Number of Participants Reporting Any Serious Adverse Event From Administration of Investigational Product Through 180 Days Post Vaccination Number of Participants Reporting New Onset Chronic Diseases From Administration of Investigational Product Through 180 Days Post Vaccination
Detailed description:
This randomized, double-blind, active controlled, multicenter study enrolled 1,800 subjects
who were 18 to 49 years of age. Subjects were randomized by site in a 4: 1:1 fashion to
receive a single dose of Q/LAIV, trivalent FluMist containing an influenza B strain from the
Yamagata lineage (FluMist/B/Yamagata), or trivalent FluMist containing an influenza B strain
from the Victoria lineage (FluMist/B/Victoria). The study was conducted at multiple sites in
the USA in the influenza off-season.
Eligibility
Minimum age: 18 Years.
Maximum age: 49 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Male or female age 18 to 49 years, inclusive, on the day of randomization (reached
his or her eighteenth year birthday but not yet reached his or her 50th year
birthday) at the time of the dose of blinded investigational product
- Written informed consent and any locally required authorization obtained from the
subject prior to performing any protocol-related procedures, including screening
evaluations
- Females of child-bearing potential, (ie, unless surgically sterile [eg, bilateral
tubal ligation, bilateral oophorectomy, or hysterectomy], had a sterile male partner,
was at least 1 year post-menopausal, or practiced abstinence) must have used an
effective method of avoiding pregnancy (including oral, transdermal, or implanted
contraceptives, intrauterine device, female condom with spermicide, diaphragm with
spermicide, cervical cap, or use of a condom with spermicide by the sexual partner)
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 subject must also have had a negative urine or blood
pregnancy test at screening and, if screening and Day 0 did not occur on the same
day, on the day of vaccination prior to randomization. Investigator judgment was
required to assess a female subject's capability of pregnancy.
- Healthy by medical history and physical examination OR presence of stable underlying
chronic medical condition for which hospitalization was not required in the previous
year
- Able to complete follow-up period of 180 days post dose of vaccine as required by the
protocol
- Subject available by telephone
- Able to understand and comply with the requirements of the protocol, as judged by the
investigator
Exclusion Criteria:
- Acute illness or evidence of significant active infection at randomization
- Fever ≥ 100. 4°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 or chronic medications 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 might have
compromised the safety of the subject in the study
- Current or expected receipt of immunosuppressive medications (inhaled and topical
corticosteroids were permitted) including corticosteroids (≥ 20 mg/day of prednisone
equivalent given daily or on alternate days for ≥ 14 days) within a 30-day window
around dose of investigational product Note: topical corticosteroids for
uncomplicated dermatitis were permitted according to the judgment of the
investigator; topical calcineurin inhibitors were permitted in accordance with their
package insert at entry and during study participation.
- 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 or standard vaccine within 30 days before
the dose of investigational product in this study through 30 days after the dose of
investigational product (use of licensed agents for indications not listed in the
package insert was permitted)
- 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
the investigational product 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 dose of
investigational product or anticipated use within 30 days after vaccination
- Known or suspected mitochondrial encephalomyopathy
- Lactating woman
- History of alcohol or drug abuse that, in the opinion of the investigator, would have
affected the subject's safety or compliance with study
- Any condition that, in the opinion of the investigator, would have interfered with
evaluation of the investigational product or interpretation of subject safety or
study results
- Employees of the clinical study site or any other individuals involved with the
conduct of the study, or immediate family members of such individuals
Locations and Contacts
Benchmark Research, Sacramento, California 95816, United States
California Research Foundation, San Diego, California 92103-6204, United States
Benchmark Research, San Francisco, California 94102, United States
University Clinical Research-Deland, LLC, Deland, Florida 32720, United States
Pharmax Research Clinic, Inc, Miami, Florida 33126, United States
University Clinical Research, Inc, Pembroke Pines, Florida 33024, United States
Miami Research Associates, South Miami, Florida 33143, United States
Clinical Research Atlanta, Stockbridge, Georgia 32801, United States
Vince and Associates Clinical Research, Overland Park, Kansas 66212, United States
Kentucky Pediatric / Adult Research, Bardstown, Kentucky 40004, United States
The Center for Pharmaceutical Research, PC, Kansas City, Missouri 64114, United States
Sundance Clinical Research, St. Louis, Missouri 63141, United States
Meridian Clinical Research, LLC, Omaha, Nebraska 68314, United States
Rochester Clinical Research, Inc., Rochester, New York 14609, United States
Clinical Research Associates, Inc, Nashville, Tennessee 37201, United States
Benchmark Research, Austin, Texas 78705, United States
Benchmark Research, Ft. Worth, Texas 76135, United States
Advanced Clinical Research, West Jordan, Utah 84088, United States
Additional Information
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Related publications: Block SL, Yi T, Sheldon E, Dubovsky F, Falloon J. A randomized, double-blind noninferiority study of quadrivalent live attenuated influenza vaccine in adults. Vaccine. 2011 Nov 21;29(50):9391-7. doi: 10.1016/j.vaccine.2011.09.109. Epub 2011 Oct 6.
Starting date: March 2009
Last updated: November 30, 2011
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