Safety and Immunogenicity of H1N1 Vaccine With Trivalent Inactivated Seasonal Influenza Vaccine in Adults
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: GSK2340274A; GSK2340273A; Seasonal trivalent influenza vaccine (TIV); Saline placebo
Intervention description: Two intramuscular injections; Two intramuscular injections; Single intramuscular injection; Single intramuscular injection
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 611.0
Sex: All
Minimum age: 19 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: GSK Bio's influenza vaccine GSK2340274A; influenza infection; GSK Bio's influenza vaccine GSK2340273A

Summary:

      The purpose of this study is to characterize the safety and immunogenicity of the H1N1
      (swine) flu vaccines GSK2340274A and GSK2340273A when co-administered with the seasonal flu
      vaccine in adults 19 to 40 years of age.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who the investigator believes can and will comply with the requirements of
             the protocol.

          -  Written informed consent obtained from the subject.

          -  Male or female adults, 19-40 years of age at the time of the first vaccination.

          -  Safety laboratory tests results within the parameters specified in the protocol.

          -  Satisfactory baseline medical assessment by physical examination.

          -  Comprehension of the study requirements, ability to comprehend and comply with
             procedures for collection of safety data, expressed availability for the required
             study period, and ability and willingness to attend scheduled visits as documented by
             signature on the informed consent document.

          -  Access to a consistent means of telephone contact, which may be either in the home or
             at the workplace, land line, or mobile, but NOT a pay phone or other multiple-user
             device.

          -  Female subjects of non-childbearing potential may be enrolled in the study.

          -  Female subjects of childbearing potential may be enrolled in the study, if the
             subject:

          -  has practiced adequate contraception for 30 days prior to vaccination, and

          -  has a negative pregnancy test on the day of first vaccination, and

          -  has agreed to continue adequate contraception during the entire treatment period and
             for 2 months after completion of the vaccination series.

        Exclusion Criteria:

          -  Previous vaccination with an H1N1v-like virus vaccine or a medical history of
             physician-confirmed infection with an H1N1v-like virus.

          -  Prior receipt at any time of any seasonal influenza vaccine.

          -  Planned administration of any vaccine not foreseen by the study protocol between Day 0
             and the Day 63 phlebotomy.

          -  Administration of any licensed vaccine within 4 weeks before the first study vaccine
             dose.

          -  Use of any investigational or non-registered product other than the study vaccines
             within 30 days preceding the first dose of study vaccine, or planned use during the
             study period.

          -  Receipt of systemic glucocorticoids within one month prior to study enrolment, or any
             other cytotoxic or immunosuppressive drug within six months of study enrolment.
             Topical, intra-articularly injected, or inhaled glucocorticoids, topical calcineurin
             inhibitors or imiquimod are allowed.

          -  Receipt of any immunoglobulins and/or any blood products within three months of study
             enrolment or planned administration of any of these products during the study period.

          -  Presence of evidence of substance abuse or of neurological or psychiatric diagnoses
             which, even if stable, are deemed by the investigator to render the potential subject
             unable/unlikely to provide accurate safety reports.

          -  Presence of a temperature >= 38.0ºC (>=100.4ºF), or acute symptoms greater than "mild"
             severity on the scheduled date of first vaccination.

          -  Diagnosed with cancer, or treatment for cancer, within 3 years.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
             medical history and physical examination.

          -  Any significant disorder of coagulation or treatment with warfarin derivatives or
             heparin. Persons receiving individual doses of low molecular weight heparin outside of
             24 hours prior to vaccination are eligible. Persons receiving prophylactic
             antiplatelet medications, e.g., low-dose acetylsalicylic acid, and without a
             clinically-apparent bleeding tendency, are eligible.

          -  An acute evolving neurological disorder or history of Guillain-Barré syndrome within
             six weeks of receipt of seasonal influenza vaccine.

          -  Any known or suspected allergy to any constituent of influenza vaccines; a history of
             anaphylactic-type reaction to any constituent of influenza vaccines; or a history of
             severe adverse reaction to a previous influenza vaccine.

          -  Known pregnancy or a positive urine beta-human chorionic gonadotropin test result
             prior to first vaccination.

          -  Lactating or nursing women.