Safety & Immunogenicity of Pneumococcal Vaccine 2189242A in Children Aged 12-23 Months at the Time of First Vaccination
Condition: Infections, Streptococcal
MeSH terms: Streptococcal Infections
Intervention: Pneumococcal vaccine GSK2189242A (formulation 1); Pneumococcal vaccine GSK2189242A (formulation 2); Pneumococcal vaccine GSK2189242A combined with pneumococcal vaccine GSK1024850A (formulation 3); Pneumococcal vaccine GSK2189242A combined with pneumococcal vaccine GSK1024850A (formulation 4); Pneumococcal vaccine GSK1024850A
Intervention description: Three doses will be administered intramuscularly, at Month 0, 2 and 6.; Three doses will be administered intramuscularly, at Month 0, 2 and 6; Three doses will be administered intramuscularly, at Month 0, 2 and 6; Three doses will be administered intramuscularly, at Month 0, 2 and 6; Three doses will be administered intramuscularly, at Month 0, 2 and 6
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 257.0
Sex: All
Minimum age: 12 Months
Maximum age: 23 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: immunogenicity; toddlers; Pneumococcal vaccine; Haemophilus influenzae; safety; Streptococcus pneumoniae; Streptococcus Pneumoniae Vaccines

Summary:

      This study will assess the safety, reactogenicity and immunogenicity of different
      formulations of GSK Biologicals' pneumococcal vaccine 2189242A when administered alone or in
      combination with the 10-valent pneumococcal conjugate vaccine (GSK1024850A vaccine) as a
      2-dose primary vaccination course followed by a booster dose in healthy children aged 12-23
      months at the time of first vaccination. Considering that febrile reactions are frequently
      observed following pneumococcal vaccination, usually co-administered with other routine
      paediatric vaccines, the primary study objective will focus on evaluating the increase in
      grade 3 fever (i.e. rectal temperature >40.0°C).
    

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

          -  Male or female between, and including, 12 and 23 months of age at the time of the
             first vaccination.

          -  Written informed consent obtained from the parents/LAR(s) of the subject.

          -  Healthy subjects as established by medical history and clinical examination before
             entering into the study.

        Exclusion Criteria:

          -  Use of any investigational or non-registered product other than the study vaccine(s)
             within 30 days preceding the first dose of study vaccine, or planned use during the
             study period.

          -  Chronic administration of immunosuppressants or other immune-modifying drugs within
             six months prior to the first vaccine dose.

          -  Planned administration/administration of a vaccine not foreseen by the study protocol
             during the study period starting from 30 days before each dose and ending 30 days
             after each dose of vaccine(s).

          -  Previous vaccination against S. pneumoniae since birth.

          -  History of any hypersensitivity reaction following any previous vaccination.

          -  Eczema and any history of allergy

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
             medical history and physical examination (no laboratory testing required), including
             human immunodeficiency virus infection.

          -  A family history of congenital or hereditary immunodeficiency.

          -  Major congenital defects or any chronic illness.

          -  History of any neurologic disorders or seizures.

          -  Acute disease and/or fever at the time of enrolment.

          -  Fever is defined as temperature >= 37.5°C on oral or axillary setting, or >= 38.0°C on
             rectal setting.

          -  Subjects with a minor illness without fever may be enrolled at the discretion of the
             investigator.

          -  Administration of immunoglobulins and/ or any blood products within the 3 months
             preceding the first dose of study vaccine or planned use during the study period.

          -  Child in care.