A Study to Evaluate the Safety of HIN1 Monovalent Vaccine (MEDI3414) in Children 2 to 17 Years of Age
Condition: Influenza
Intervention: MEDI3414 [Influenza A(H1N1) live attenuated, intranasal]; Placebo
Intervention description: 0.5 mL: (intranasal sprayer); 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: 326.0
Sex: All
Minimum age: 2 Years
Maximum age: 17 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: randomized, double-blind, placebo-controlled

Summary:

      The purpose of this study was to determine the safety and descriptive immunogenicity of the
      H1N1 influenza vaccine in healthy children.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, 2 to 17 years of age (not yet reached their 18th birthday) at the time
             of randomization

          -  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 and written informed assent)
             obtained from the subject/legal representative prior to performing any
             protocol-related procedures, including screening evaluations

          -  Females of child-bearing potential, (ie, unless premenarchal, surgically sterile [eg,
             bilateral tubal ligation, bilateral oophorectomy, or hysterectomy], has sterile male
             partner, or practices abstinence) must use 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 agree to continue using such precautions for 60 days
             after the second dose of investigational product. In addition, the subject must also
             have a negative urine or blood pregnancy test at screening and, if screening and Day 1
             do not occur on the same day, on the day of vaccination prior to randomization.
             Investigator judgment is required to assess the childbearing potential of a
             pre-adolescent or adolescent girl.

          -  Males, unless not sexually active, must use an effective method of birth control with
             a female partner and must agree to continue using such contraceptive precautions for
             at least 30 days after the second dose of investigational product (from Day 1 through
             Day 59 of the study)

          -  Subject's legal representative available by telephone

          -  Subject/subject's legal representative is able 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 Dose 2 as required by the
             protocol

        Exclusion Criteria:

          -  History of hypersensitivity to any component of the investigational product including
             egg or egg protein, gelatin or arginine, or serious, life-threatening, or severe
             reactions to previous influenza vaccinations

          -  History of hypersensitivity to gentamicin

          -  Any condition for which the inactivated influenza vaccine is 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

          -  History of asthma, or in children < 5 years of age, history of recurrent wheezing

          -  Any known immunosuppressive condition or immune deficiency disease, including human
             immunodeficiency virus infection, or ongoing immunosuppressive therapy

          -  History of Guillain-Barré syndrome

          -  A household contact who is severely immunocompromised (eg, hematopoietic stem cell
             transplant recipient, during those periods in which the immunocompromised individual
             requires care in a protective environment); subject should additionally avoid 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 second dose of investigational product (use
             of licensed agents for indications not listed in the package insert is permitted)

          -  Use of aspirin or salicylate-containing products within 30 days prior to randomization
             or expected receipt through 30 days after final vaccination

          -  Expected receipt of antipyretic or analgesic medication (non-salicylate-containing) on
             a daily or every other day basis from randomization through 14 days after receipt of
             each dose of investigational product

          -  Administration of intranasal medications within 14 days prior to randomization, or
             expected receipt through 14 days after administration of each dose of investigational
             product

          -  Receipt of any nonstudy vaccine within 30 days before or after Dose 1 or expected
             receipt of any nonstudy vaccine within 30 days before or after Dose 2

          -  Known or suspected mitochondrial encephalomyopathy

          -  Adolescent subject is pregnant or a nursing mother

          -  Any condition (eg, chronic cough, allergic rhinitis) that, in the opinion of the
             investigator, would interfere with evaluation of the investigational product or
             interpretation of subject safety or study results

          -  Subject, legal representative, or immediate family member of subject is an employee of
             the clinical study site or is otherwise in involved with the conduct of the study