Evaluation of Effectiveness of GSK Biologicals' Pneumococcal Conjugate Vaccine 1024850A Against Invasive Disease
Condition: Infections, Streptococcal; Streptococcus Pneumoniae
MeSH terms: Pneumonia; Pneumonia, Pneumococcal; Streptococcal Infections
Intervention: Pneumococcal conjugate vaccine GSK1024850A; GSK Biologicals' Engerix TM vaccine (Hepatitis B vaccine); GSK Biologicals' Havrix TM vaccine (Hepatitis A vaccine)
Intervention description: 2, 3 or 4 Intramuscular injections, depending on the age at the time of first vaccination; 3 or 4 Intramuscular injections, depending on the age at the time of first vaccination.
Control 3+1 and Control 2+1 groups, only for children < 12 months of age at the time of first study vaccination.; 2 Intramuscular injections. Control 3+1 and Control 2+1 groups, only for children >= 12 months of age at the time of first study vaccination.
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 41188.0
Sex: All
Minimum age: 6 Weeks
Maximum age: 18 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Pneumococcal conjugate vaccine; Invasive disease; Respiratory tract infections; Haemophilus influenzae; Streptococcus pneumoniae; Acute otitis media; Pneumonia

Summary:

      The aim of this study is to assess the effectiveness of GSK Biologicals' pneumococcal
      conjugate vaccine (GSK1024850A), administered according to different vaccination schedules,
      against invasive disease caused by S. pneumoniae or H. influenzae as well as vaccine impact
      on the occurrence of hospital-diagnosed pneumonia cases, tympanostomy tube placement and
      outpatient antimicrobial prescriptions.

      This study will also explore vaccine impact on occurrence of respiratory tract infections
      (RTIs), including acute otitis media (AOM) in a subset of children in Turku area.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female between, and including, 6 weeks to 18 months of age at the time of the
             first vaccination.

          -  Written informed consent obtained from parent(s) or from the guardian(s) of the
             subject.

        Exclusion Criteria:

          -  Previous vaccination with any registered, non-registered or investigational
             pneumococcal vaccine other than the study vaccine, or planned use during the study
             period. If a child belongs to a high risk group for pneumococcal infections for which
             a licensed pneumococcal conjugate vaccine is made locally available, the subject can
             not be enrolled in the study and should be referred to the specific immunization
             program.

          -  Previous vaccination against Hepatitis B virus with any registered, non-registered or
             investigational vaccine, or planned use of such a vaccine other than the study vaccine
             during the study period.

          -  Previous vaccination against Hepatitis A virus with any registered, non-registered or
             investigational vaccine, or planned use of such a vaccine other than the study vaccine
             during the study period.

          -  Known severe hypersensitivity to any component of the study vaccines, including
             neomycin.

          -  Any medical condition that would contraindicate the initiation of routine immunization
             outside a clinical trial context.