Study to Evaluate Safety and Immunogenicity of GSK Biologicals' Pandemic Influenza (H1N1) Candidate Vaccine in Children
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: GSK2340272A GSK Biologicals' investigational influenza pandemic vaccine; Infanrix™-IPV/Hib; Prevenar
Intervention description: Two doses; intramuscular administration; Routine infant immunisation vaccine, three doses administered intramuscularly; Routine infant immunisation vaccine, three doses administered intramuscularly
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 8 Weeks
Maximum age: 12 Weeks
Healthy volunteers: Accepts Healthy Volunteers
Keywords: GSK2340272A; H1N1 pandemic influenza

Summary:

      The purpose of this study is to assess the safety and immunogenicity of two doses of the H1N1
      candidate vaccine administered in children aged between 8 and 12 weeks at the time of first
      vaccination.
    

Eligibility criteria:

        Inclusion Criteria:

        All subjects must satisfy ALL the following criteria at study entry:

          -  Subjects who the investigator believes that their parent(s)/Legally Acceptable
             Representative(s) (LARs) can and will comply with the requirements of the protocol

          -  Children, male or female, aged between 8 and 12 weeks at the time of first study
             vaccination.

          -  Written informed consent obtained from the parent(s)/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.

          -  Born after a gestation period of >= 36 to <= 42 weeks.

        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:

          -  Use of any investigational or non-registered product (drug or vaccine) other than the
             study vaccine within 30 days preceding the first dose of the study vaccine or planned
             use during the study period.

          -  Acute disease at the time of enrolment.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition based on
             medical history and physical examination (no laboratory testing required).

          -  History of any neurological disorders or seizures.

          -  A family history of congenital or hereditary immunodeficiency.

          -  Receipt of systemic glucocorticoids within one month of study enrolment, or any other
             cytotoxic or immunosuppressive drug since birth.

          -  Administration of any vaccines within two weeks before study enrolment.

          -  Administration of immunoglobulins and/or any blood products since birth or planned
             administration during the study.

          -  Previous administration of any H1N1 vaccine, of any seasonal influenza vaccine.

          -  Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis,
             Haemophilus influenzae type b, and/or Streptococcus pneumoniae with the exception of
             vaccines where the first dose can be given within the first two weeks of life
             according to the national recommendations.

          -  History of intercurrent diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus
             influenzae type b disease.

          -  Major congenital defects or serious chronic illness.

          -  Child in care.

          -  Any known or suspected allergy to any constituent of the influenza, DTPa-IPV/Hib and
             pneumococcal study vaccines; a history of anaphylactic-type reaction to consumption of
             eggs; or a history of severe adverse reaction to a previous influenza, DTPa-IPV/Hib
             and pneumococcal vaccine.