Study of GSK Biologicals' Pandemic Influenza (H1N1) Candidate Vaccine in Children Aged 10 to Less Than 18 Years
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: GSK Biologicals' Influenza investigational vaccine GSK2340274A; GSK Biologicals' Influenza investigational vaccine GSK2340273A; Placebo (saline)
Intervention description: One or two doses administered intramuscularly; Two doses intramuscularly; One dose intramuscularly
Intervention MeSH terms: Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 310.0
Sex: All
Minimum age: 10 Years
Maximum age: 17 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: pandemic influenza; Clinical trial; H1N1; children

Summary:

      The purpose of this study is to show that vaccination with a single dose of GSK Biologicals'
      pandemic H1N1 vaccine results in an immune response that meets or exceeds European Medicines
      Agency (EMEA) Committee for Medicinal Products for Human Use (CHMP) guidance criteria for a
      pandemic influenza vaccine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female children 10 to < 18 years of age at the time of the first vaccination.
             "Less than 18 years of age" implies inclusion of adolescents who have not reached
             their 18th birthday as of Day 0, the day of the first vaccine dose under this
             protocol.

          -  Written informed consent obtained from the subject's parent/legally acceptable
             representative (LAR); written informed assent obtained from the subject if
             appropriate.

          -  Good general health as established by medical history and clinical examination before
             entering into the study.

          -  Parent/LAR access to a consistent means of telephone contact, land line or mobile, but
             NOT a pay phone or other multiple-user device.

          -  Subjects who the investigator believes that they and/or their parent(s)/LAR can and
             will comply with the requirements of the protocol.

        Exclusion Criteria:

          -  Medical history of physician-confirmed infection with an A/California/7/2009
             (H1N1)v-like virus.

          -  Previous vaccination at any time with an A/California/7/2009 (H1N1)v-like virus
             vaccine.

          -  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 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 vaccine within 30 days before the first dose of study
             vaccine, with the exception of seasonal influenza vaccine (which may be given within 2
             weeks before the first dose of study vaccine).

          -  Planned administration of any A/California H1N1v-like vaccine other than the study
             vaccine between Day 0 and the Day 189 phlebotomy.

          -  Planned administration of any other vaccine not foreseen by the study protocol between
             Day 0 and Day 42 after the first vaccine dose, including seasonal influenza vaccine.
             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.

          -  Use of any investigational or non-registered product (drug or vaccine) other than the
             study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned
             use during the study period.

          -  Any known or suspected allergy to any constituent of influenza vaccines; 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.