A Prospective Study to Evaluate the Safety of a New Monovalent Intranasal Influenza Vaccine
Condition: Healthy
MeSH terms: Influenza, Human
Intervention: Monovalent influenza virus vaccine; Placebo
Intervention description: Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of the cold-adapted, attenuated, 6:2 reassortant influenza strain B/Brisbane/60/2008 (Victoria lineage).; Placebo was supplied in intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer.
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 300.0
Sex: All
Minimum age: 18 Years
Maximum age: 49 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: influenza; FluMist

Summary:

      This prospective annual release study was designed to assess the safety of a monovalent
      influenza virus vaccine using a new strain recommended for the 2009-2010 influenza season not
      previously contained in the trivalent intranasal FluMist vaccine. Three hundred healthy
      adults received a single dose of vaccine or placebo and were followed for 180 days.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, 18 to 49 years of age (not yet reached their 50th birthday) at the
             time of investigational product administration

          -  Healthy by medical history and physical exam

          -  Written informed consent and any locally required authorization (eg, Health Insurance
             Portability and Accountability Act [HIPAA] in the United States of America [USA],
             European Union [EU] Data Privacy Directive in the EU) obtained from the subject/legal
             representative prior to performing any protocol-related procedures, including
             screening evaluations

          -  Females of childbearing potential, unless surgically sterile (ie, bilateral tubal
             ligation, bilateral oophorectomy, or complete hysterectomy), had sterile male partner,
             were premenarchal or at least 2 years postmenopausal, or practiced abstinence, must
             have used 2 effective methods 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 at least 30 days prior to dosing with investigational product, and
             must have agreed to continue using such precautions for at least 90 days after dosing
             with investigational product; cessation of birth control after this point was to be
             discussed with a responsible physician. The subject must also have had a negative
             serum or urine pregnancy test within 14 days prior to investigational product
             administration (if screening and administration of investigational product did not
             occur on the same day) and on the day of investigational product administration prior
             to randomization

          -  Males, unless surgically sterile, must have used 2 effective methods of birth control
             with a female partner and must have agreed to continue using such contraceptive
             precautions for at least 30 days after dosing with investigational product (from Day 1
             through Day 31 of the study)

          -  Subject available by telephone

          -  Ability to understand and comply with the requirements of the protocol, as judged by
             the investigator

          -  Ability to complete follow-up period of 180 days after dosing as required by the
             protocol

        Exclusion Criteria:

          -  History of hypersensitivity to any component of the vaccine, including egg or egg
             protein or serious, life-threatening, or severe reactions to previous influenza
             vaccinations

          -  History of hypersensitivity to gentamicin

          -  Any condition for which the inactivated influenza vaccine was indicated, including
             chronic disorders of the pulmonary or cardiovascular systems (eg, asthma), chronic
             metabolic diseases (eg, diabetes mellitus), renal dysfunction, or hemoglobinopathies
             that required regular medical follow-up or hospitalization during the preceding year

          -  Acute febrile (> 100.0°F oral or equivalent) and/or clinically significant respiratory
             illness (eg, cough or sore throat) within 14 days prior to randomization

          -  Any known immunosuppressive condition or immune deficiency disease, including human
             immunodeficiency virus [HIV] infection, or ongoing immunosuppressive therapy

          -  History of Guillain-Barré syndrome

          -  A household contact who was severely immunocompromised (eg, hematopoietic stem cell
             transplant recipient, during those periods in which the immunocompromised individual
             required care in a protective environment); subject should additionally have avoided
             close contact with severely immunocompromised individuals for at least 21 days after
             receipt of investigational product

          -  Receipt of any investigational agent within 30 days prior to randomization, or
             expected receipt through 30 days after the dose of investigational product (use of
             licensed agents for indications not listed in the package insert was permitted)

          -  Expected receipt of anti-pyretic or analgesic medication on a daily or every other day
             basis from randomization through 14 days after receipt of investigational product

          -  Administration of intranasal medications within 14 days prior to randomization, or
             expected receipt through 14 days after administration of investigational product

          -  Known or suspected mitochondrial encephalomyopathy

          -  Nursing mother

          -  Any condition (eg, chronic cough, allergic rhinitis) 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