Phase
Condition
Influenza
Treatment
N/AClinical Study ID
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male or female age 18 to 49 years, inclusive, on the day of randomization (reached hisor her 18th year birthday but not yet reached his or her 50th year birthday) at thetime of the dose of study product
Written informed consent and a locally required authorization (eg, HIPAA in the USA, )obtained from the subject prior to performing any protocol-related procedures.
Females of child-bearing potential, (ie, unless surgically sterile [eg, bilateraltubal ligation, bilateral oophorectomy, or hysterectomy], has sterile male partner, isat least 1 year post-menopausal, or practices abstinence) must use an effective methodof 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 daysprior to the first dose of study product, and must agree to continue using suchprecautions for 60 days after the dose of vaccine due to a potential dose of livevaccine product. In addition, the subject must also have a negative urine or bloodpregnancy test at screening and, if screening and Day 0 do not occur on the same day,a negative urine pregnancy test on the day of vaccination prior to randomization.Investigator judgment is required to assess a female subject's capability ofpregnancy.
Are in good health, as determined by vital signs, medical history to ensure anyexisting medical diagnoses or conditions are stable and not considered clinicallysignificant by physician investigator, and targeted physical examination based onmedical history.
Able to complete follow-up period of 180 days post dose of vaccine as required by theprotocol
Subject available by telephone
Able to understand and comply with the requirements of the protocol, as judged by theinvestigator
Exclusion
Exclusion Criteria: Any of the following would exclude the subject from participation in the study:
Have an acute illness, including an oral temperature ≥ 100.4°F, within 3 days prior tovaccination.
Participated in an investigational influenza vaccine study or had a known infectionwith "flu" since 2007 (confirmed by laboratory culture, including subtype of theinfluenza A virus (H1N1) investigational vaccines or illness).
Previous vaccination against influenza in 2007, 2008, 2009 or 2010 with seasonaltrivalent live or inactivated influenza vaccine (including H1N1 vaccines).
Current or expected receipt of immunosuppressive medications (inhaled and topicalcorticosteroids are permitted) including corticosteroids (≥ 20 mg/day of prednisoneequivalent given daily or on alternate days for ≥ 14 days) within a 30 day windowaround dose of study vaccine product Note: topical corticosteroids for uncomplicateddermatitis may be used throughout the study according to the judgment of theinvestigator; topical calcineurin inhibitors may be used in accordance with theirpackage insert at entry and during study participation.
Receipt of immunoglobulin or blood products within 90 days before randomization intothe study or expected receipt during study participation
Received an experimental agent within 1 month prior to vaccination in this study orexpect to receive an experimental agent during the active study period (prior to Day 60 after vaccination (Experimental agent includes: vaccine, biologic, device, ormedication).
Have received any live licensed vaccines within 4 weeks or inactivated licensedvaccines within 2 weeks prior to vaccination in this study or plan receipt of suchvaccines within 60 days following the vaccination.
Any known immunosuppressive condition or immune deficiency disease including knowncancer illness or organ transplant
Have known active HIV, Hepatitis B or Hepatitis C infection.
Have a known allergy to eggs or other components of the vaccine (including gelatin,formaldehyde, octoxinol, thimerosal, gentamycin and chicken protein) or severereactions 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 study vaccineproducts or anticipated use within 30 days after vaccination
Breastfeeding woman
History of alcohol or drug abuse that, in the opinion of the investigator, wouldaffect the subject's safety or compliance with study
Previous medical history, evidence of an intercurrent illness or any condition that,in the opinion of the investigator, would interfere with evaluation of the studyvaccine products or interpretation of subject safety or that may compromise the safetyof the subject in the study.