Safety, 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
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 157.0
Sex: All
Minimum age: 6 Months
Maximum age: 35 Months
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 6 and 35
      months.

      This protocol posting has been updated following protocol amendment 4, March 2010. The
      protocol posting sections impacted are number of subjects, primary and secondary endpoints
      and intervention.
    

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 6 and 35 months at the time of first study
             vaccination.

          -  Written informed consent obtained from the parent(s) or LAR(s) of the subject.

          -  Healthy children, as established by medical history and clinical examination when
             entering 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 device.

        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.

          -  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.

          -  History of hypersensitivity to vaccines.

          -  History of allergic disease or reactions likely to be exacerbated by any component of
             the vaccines

          -  History of any neurological disorders or seizures.

          -  Acute disease and/or fever at the time of enrolment

          -  Administration of immunoglobulins and/or any blood products within the three months
             prior to the enrolment in this study, or planned during the study.

          -  Any condition which, in the opinion of the investigator, renders the subject unfit for
             participation in the study.

          -  Child in Care.