Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety of MEDI3414 in Adults
Brief Summary: The purpose of this study was to determine the safety and descriptive immunogenicity of the H1N1 influenza vaccine in healthy adults.


Options:
A: 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
B: Group A:

Inclusion Criteria:

* Hutterites other than the healthy children who will be immunized. Although this category as a whole will be used to assess indirect benefit of the vaccine in the main analysis, Hutterites at high risk for influenza complications within this category will be assessed in a separate analysis. These are defined as anyone in one or more of the following groups:
* individuals aged ≥ 65 years
* children 23 months of age or less
* anyone with ≥ 1 of the following conditions severe enough to require regular medical follow-up or hospital care:

  * chronic cardiac or pulmonary disorders (including bronchopulmonary dysplasia, cystic fibrosis, and asthma)
  * diabetes mellitus and other metabolic diseases
  * cancer
  * immunodeficiency
  * immunosuppression (due to underlying disease and/or therapy)
  * renal disease
  * anemia
  * hemoglobinopathy
  * any condition that can compromise respiratory function or the handling of respiratory secretions or that can increase the risk of aspiration.

Exclusion Criteria:

* There are no exclusion criteria for this category of participants.

Group B:

Inclusion Criteria:

* Healthy children aged 36 months to 15 years who will be immunized as part of the intervention.

Exclusion Criteria:

* Anaphylactic reaction to a previous dose of influenza vaccine
* Anaphylactic reaction to hepatitis A vaccine
* Anaphylactic reaction to neomycin
* Known IgE-mediated hypersensitivity to eggs manifested as hives
* Swelling of the mouth and throat, difficulty in breathing, hypotension, or shock
* Guillain-Barré syndrome within eight weeks of a previous influenza vaccine.
C: Inclusion Criteria:

* Healthy male or female child at least 24 months of age and no older than 59 months of age at the time of study vaccination.
* A child whose parent or guardian's primary residence, at the time of study vaccinations, is within the Kamalapur surveillance site catchment area or Matlab service area and who intends to be present in the area for the duration of the trial.
* A child whose parent or legal guardian is willing to provide written informed consent prior to the participant's study vaccination.

Exclusion Criteria:

* Has any serious, active, medical conditions, including: a chronic disease of any body system, chronic infections such as tuberculosis, genetic disorders, such as Down's syndrome or other cytogenetic disorder, known or suspected disease of the immune system.
* Is receiving immunosuppressive agents, including systemic corticosteroids, during the month prior to study vaccination.
* Has a history of documented hypersensitivity to eggs or other components of the vaccine (including gelatin, sorbitol, lactalbumin and chicken protein), or with life-threatening reactions to previous influenza vaccinations.
* Has ever received influenza vaccine (LAIV or inactivated).
* History of Guillain-Barre syndrome
* Is receiving aspirin therapy or aspirin-containing therapy currently or two weeks before.
* Lives in household with somebody currently participating in a respiratory vaccination or antiviral study.
* Has current or past participation (within 2 months of trial enrollment visit) in any clinical trial involving a drug or biologic with activity against respiratory disease.
* History of a previous severe allergic reaction with generalized urticarial, angioedema, or anaphylaxis.
* Has any condition determined by investigator as likely to interfere with evaluation of the vaccine or be a significant potential health risk to the child or make it unlikely that the child would complete the study

Temporary Inclusion Contraindications:

* Concurrent febrile illness (measured temperature 38 degrees C axillary).
* Active wheezing illness
D: Inclusion Criteria:

* Male or female, 18 to 49 years of age (not yet reached their 50th birthday) at the time of randomization
* Healthy by medical history and physical examination
* 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, (ie, unless surgically sterile \[eg, bilateral tubal ligation, bilateral oophorectomy, or hysterectomy\], has sterile male partner, is at least 1 year post menopause, 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.
* 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 is available by telephone
* Subject is able to understand and comply with the requirements of the protocol, as judged by the investigator
* Subject is able 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
* 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)
* Expected receipt of antipyretic or analgesic medication 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
* 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 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

Answer: D