Safety and Immune Response of Candidate H1N1 Influenza Vaccines GSK2340274A and GSK234072A in Children 3 to Less Than 10 Years Old
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: GSK Biologicals' GSK2340274A (two different formulations); GSK Biologicals' - GSK2340272A
Intervention description: Intramuscular injection; Intramuscular injection
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 209.0
Sex: All
Minimum age: 3 Years
Maximum age: 9 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: H1N1; Influenza; Pandemic; GSK Bio's influenza vaccines GSK2340274A and GSK234072A

Summary:

      This study is designed to characterize the safety and immunogenicity of pandemic influenza
      (H1N1) candidate vaccines GSK2340274A and GSK234072A in children 3 to less than 10 years old.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or pre-menarchal female children 3 to < 10 years of age at the time of the study
             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 the study 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.

          -  Subjects and/or parent(s)/LAR who the investigator believes can and will comply with
             the requirements of the protocol as documented by signature on the informed consent
             document (and, if appropriate, the informed assent document).

        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 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 (no laboratory testing required).

          -  Receipt of systemic glucocorticoids within 1 month prior to study enrollment (day of
             study vaccination), 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.

          -  Administration of any licensed live-attenuated vaccine within 30 days before study
             vaccination or any licensed inactivated vaccine within 15 days before study
             vaccination.

          -  Planned administration of any A/California H1N1v-like vaccine other than the study
             vaccine between Day 0 and the Day 21 phlebotomy.

          -  Planned administration of any other vaccine not foreseen by the study protocol between
             Day 0 and Day 21. 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 study vaccination, 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 (A child who has been placed under the control or protection of an
             agency, organization, institution or entity by the courts).