A Study to Evaluate the Safety and Immunogenicity of a Prime-boost Schedule of GSK Biologicals' Influenza Vaccine in Children
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Influenza vaccine GSK1562902A Formulation 1; Influenza vaccine GSK1562902A Formulation 2; Havrix™; Havrix™ Junior
Intervention description: Intramuscular injection, two doses each in GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and GSK1562902A Formulation 1 - Havrix / Havrix Jr Group; Intramuscular injection, one dose each in GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and GSK1562902A Formulation 2 - Havrix / Havrix Jr Group; Intramuscular injection, one dose in GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and two doses each in GSK1562902A Formulation 1 - Havrix / Havrix Jr Group, GSK1562902A Formulation 2 - Havrix / Havrix Jr Group and Havrix / Havrix Jr Group; Intramuscular injection, one dose in GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and two doses each in GSK1562902A Formulation 1 - Havrix / Havrix Jr Group,GSK1562902A Formulation 2 - Havrix / Havrix Jr Group and Havrix / Havrix Jr Group
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 520.0
Sex: All
Minimum age: 3 Years
Maximum age: 17 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: influenza; H5N1; vaccine; children

Summary:

      The purpose of this study is to assess the safety and immunogenicity of a prime-boost
      schedule of GSK Biologicals' influenza vaccine in children aged 3 to 17 years.
    

Eligibility criteria:

        Inclusion Criteria:

        All subjects must satisfy ALL the following criteria at study entry:

          -  Subjects for whom the investigator believes that the parent(s)/Legally Acceptable
             Representative(s) [LAR(s)] can and will comply with the requirements of the protocol .

          -  A male or female child 3 to 17 years of age inclusive, at the time of the first
             vaccination.

          -  Written informed consent obtained from the subject's parent or guardian. Assent
             obtained from the subject when applicable.

          -  Good general health as established by medical history and clinical examination before
             entering into the study.

          -  Comprehension by the subject's parent or guardian of the study requirements, ability
             to comprehend and comply with procedures for collection of short- and long-term safety
             data, expressed availability for the required study period, and ability and
             willingness to attend scheduled visits.

          -  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 (i.e., a common-use phone
             serving multiple rooms or apartments).

          -  Female subjects of childbearing potential may be enrolled in the study, if the
             subject:

               -  has practiced adequate contraception for 30 days prior to vaccination, and

               -  has a negative pregnancy test on the day of vaccination, and

               -  has agreed to continue adequate contraception during the entire treatment period
                  and for 2 months after completion of the vaccination series.

        Exclusion Criteria:

        The following criteria should be checked at the time of study entry. If ANY exclusion
        criterion applies, the subject must not be included in the study:

          -  Child in care

          -  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.

          -  Planned administration of any vaccine 30 days prior and 21 days after any study
             vaccine administration.

          -  Active participation in other clinical trials.

          -  Receipt of systemic glucocorticoids within 1 month prior to study enrollment, or any
             other cytotoxic or immunosuppressive drug within 6 months of study enrollment.
             Topical, intra-articular or inhaled glucocorticoids are allowed.

          -  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 (no laboratory testing required).

          -  Acute or chronic, clinically-significant pulmonary, cardiovascular, hepatic or renal
             functional abnormality, as determined by medical history and physical examination.

          -  An acute evolving neurological disorder or history of Guillain-Barré syndrome within 6
             weeks of receipt of seasonal influenza vaccine.

          -  Receipt of any immunoglobulins and/or any blood products within 9 months of study
             enrolment or planned administration of any of these products during the study period.

          -  Any known or suspected allergy to any constituent of influenza vaccines ; a history of
             anaphylactic-type reaction to vaccine components or a history of severe adverse
             reaction to a previous influenza vaccine.

          -  History of seizures or progressive neurological disease.

          -  Pregnant or lactating female.

          -  Female planning to become pregnant or planning to discontinue contraceptive
             precautions.

          -  Diagnosed with cancer or any chronic severe disease.

          -  Previous administration of any H5N1 vaccine.