Safety and Efficacy of H1N1 Vaccines in Children Aged 6 Months to Less Than 10 Years of Age
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: GSK Biologicals' investigational vaccine GSK2340274A (alternative formulations); GSK Biologicals' investigational vaccine GSK2340273A (alternative formulations); Placebo
Intervention description: Intramuscular injection, one or two doses; Intramuscular injection, two doses; Intramuscular injection, one dose
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 6154.0
Sex: All
Minimum age: 6 Months
Maximum age: 9 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Influenza; H1N1; Pandemic

Summary:

      The purpose of this study is to characterize the safety and efficacy of GSK Biologicals' H1N1
      flu candidate vaccines GSK2340274A and GSK2340273A in children 6 months to less than 10 years
      of age.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female children 6 months to less than 10 years of age at the time of the first
             vaccination. "Less than 10 years of age" implies inclusion of children who have not
             reached their 10th birthday as of Day 0, the day of first vaccine dose under this
             protocol.

          -  Written informed consent obtained from the subject's parent(s)/legally acceptable
             representative(s) (LAR(s)); written informed assent obtained from the subject if
             appropriate pre local requirements).

          -  Stable health status as defined by absence of a health event satisfying the definition
             of a SAE, or a change in an ongoing drug therapy due to therapeutic failure or
             symptoms of drug toxicity, within 1 month prior to enrolment.

          -  Parent(s)/LAR(s) available and accessible for active surveillance contacts.

          -  Parent(s)/LAR(s) and (if age-appropriate, subjects) who, in the investigator's
             opinion, can and will comply with the requirements of the protocol as documented by
             signature on the informed consent document.

          -  Female subjects of non-childbearing potential (pre-menarche) may be enrolled in the
             study.

        Exclusion Criteria:

          -  Previous vaccination with an A/California/7/2009 (H1N1)v-like virus vaccine.

          -  Medical history of physician-confirmed infection with an A/California/7/2009
             (H1N1)v-like virus.

          -  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
             or parent(s)/LAR(s) unable/unlikely to provide accurate safety reports.

          -  Presence of a temperature ≥ 38.0ºC (≥ 100.4ºF) by any route or method, or acute
             symptoms greater than "mild" severity on the scheduled date of first vaccination.
             NOTE: The subject may be vaccinated at a later date, provided symptoms have resolved,
             vaccination occurs within the window specified by the protocol, and all other
             eligibility criteria continue to be satisfied.

          -  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 (no laboratory testing required).

          -  Receipt of systemic glucocorticoids within 1 month prior to study enrollment (first
             dose of study vaccine), or any other cytotoxic or immunosuppressive drug within 6
             months of study enrollment. Topical, intra-articular or inhaled glucocorticoids are
             allowed.

          -  Receipt of any immunoglobulins and/or any blood products within 6 months of study
             enrollment or planned administration of any of these products during the study period.

          -  Any significant disorder of coagulation or treatment with warfarin derivatives or
             heparin. Persons receiving individual doses of low molecular weight heparin are
             eligible if no such doses are given in the 24 hours before a study vaccination.
             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 6
             weeks of receipt of seasonal influenza vaccine.

          -  Administration of any licensed live attenuated vaccine within 4 weeks before the first
             vaccination or of any licensed inactivated vaccine within 2 weeks before the first
             vaccination.

          -  Planned administration of any vaccine not foreseen by the study protocol between Day 0
             and Day 42. Routine childhood vaccinations are exempted if they cannot be delayed, but
             they must not be administered on the same day as the H1N1 vaccine candidate.

          -  Planned use of a pandemic monovalent A/California/7/2009 (H1N1)v-like virus vaccine
             other than the study vaccines during the study period.

          -  Planned administration of seasonal trivalent influenza vaccine during the 4 month
             period following Day 0.

          -  Use of any investigational or non-registered product (drug or vaccine) other than the
             study vaccine(s) within 30 days before the first dose of study vaccine, or planned use
             during the study period.

          -  Any known or suspected allergy to any constituent of influenza vaccines (including egg
             proteins or mercurial preservatives); a history of anaphylactic-type reaction to
             consumption of eggs; or a history of severe adverse reaction to a previous influenza
             vaccine.

          -  Child in care.