A Study to Evaluate the Immunogenicity of Quadrivalent LAIV in Adults 18 to 49 Years of Age
A Study to Evaluate the Immunogenicity of Quadrivalent LAIV in Adults 18 to 49 Years of Age
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.
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.
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