Impact on Carriage, Acute Otitis Media, Immuno & Safety of GSK Biologicals' Pneumococcal Conjugate Vaccine 1024850A
Condition: Infections, Streptococcal; Streptococcus Pneumoniae
MeSH terms: Pneumonia; Pneumonia, Pneumococcal; Streptococcal Infections; Otitis; Otitis Media
Intervention: Pneumococcal conjugate vaccine Synflorix (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 only for children < 12 months of age at the time of first study vaccination.; 2 Intramuscular injections 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: 6181.0
Sex: All
Minimum age: 6 Weeks
Maximum age: 18 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Streptococcus pneumoniae; acute otitis media; Pneumococcal conjugate vaccine; nasopharyngeal carriage; Haemophilus influenzae; immunogenicity; invasive disease

Summary:

      The aim of this study is to assess the effectiveness of GSK Biologicals' pneumococcal
      conjugate vaccine (GSK1024850A) in preventing invasive disease caused by S. pneumoniae or H.
      influenzae and in reducing occurrence of hospital-diagnosed pneumonia cases, tympanostomy
      tube placement and outpatient antimicrobial prescriptions in children starting vaccination
      below 18 months of age. These data will be collected from the national registers and will be
      analyzed in combination with data collected for subjects enrolled in a large scale
      cluster-randomized study 111442.

      The study will also assess the immune response to the GSK1024850A vaccine and the impact of
      the vaccine on occurrence of acute otitis media, carriage, safety in children starting
      vaccination below 18 months of age.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who the investigator believes that their parent(s)/guardian(s) can and will
             comply with the requirements of the protocol should be enrolled in the study.

          -  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:

          -  Use of any investigational or non-registered product (drug or vaccine) within 30 days
             preceding the first dose of study vaccine, or planned use of such a vaccine(s) other
             than the study vaccine(s) during the entire study period.

          -  Previous vaccination with any registered, non-registered or investigational
             pneumococcal vaccine, or planned use of such a vaccine other than the study vaccine
             during the study period. If a child belongs to a high risk group for pneumococcal
             infections (such as children with an anatomic or functional asplenia, HIV infection,
             chronic cardiac or respiratory disease (not asthma), diabetes, cochlear implant, CSF
             fistula or with significant immunodeficiency) 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.