Safety and Immunogenicity Study of GSK Biologicals' Pandemic Influenza Candidate Vaccine (H1N1) (GSK2340272A)
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Pandemic influenza vaccine GSK2340272A
Intervention description: Two primary intramuscular (IM) injections and a booster IM injection
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 210.0
Sex: All
Minimum age: 3 Years
Maximum age: 17 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: influenza infection; GSK Bio's influenza vaccine GSK2340272A

Summary:

      This trial is designed to assess the safety and immunogenicity of a prime-boost schedule of
      GSK Biologicals' investigational vaccine GSK2340272A in children aged between 3 and 17 years.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who the investigator believes that their parent(s)/Legally Acceptable
             Representative(s) (LAR) can and will comply with the requirements of the protocol.

          -  Children, male or female, aged between 3 and 17 years at the time of the first study
             vaccination.

          -  Written informed consent obtained from the subject parent(s) or LAR(s) of the subject.
             Assent obtained from the subject when applicable.

          -  Healthy children as established by medical history and clinical examination when
             entering into the study.

          -  Parent/LAR with access to a consistent means of telephone contact, land line or
             mobile, but NOT a pay phone or other multiple-user.

        Exclusion Criteria:

          -  Use of any investigational or non-registered product other than the study vaccine
             within 30 days preceding the first dose of the study vaccine or planned use during the
             study period.

          -  Clinically or virologically confirmed influenza infection within six months preceding
             the study start.

          -  Planned administration of any vaccine 30 days prior and 30 days after any study
             vaccine administration.

          -  Chronic administration of immunosuppressants or other immune-modifying drugs within
             three months prior to enrolment in this study or planned administration during the
             study period.

          -  Acute disease and/or fever at the time of enrolment

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition based on
             medical history and physical examination.

          -  Acute or chronic, clinically-significant pulmonary, cardiovascular, hepatic or renal
             functional abnormality, as determined by medical history and physical examination.

          -  Previous administration of any H1N1 A/California-like vaccine.

          -  Administration of immunoglobulins and/or any blood products within the three months
             prior to the enrolment in this study, or planned during the study.

          -  If the subject is female and if she is of childbearing potential, she must practice
             adequate contraception for 30 days prior to vaccination, have a negative pregnancy
             test and continue such precautions for two months after completion of the vaccination
             series.

          -  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 use of an analgesic or antipyretic medication within 12 hours prior to first
             vaccination.

          -  Child in Care.