Immunogenicity and Safety of Two Formulations of GSK Biologicals' Pneumococcal Vaccine (2830929A and 2830930A) When Administered in Healthy Infants
Condition: Infections, Streptococcal
MeSH terms: Streptococcal Infections
Intervention: Pneumococcal conjugate vaccine GSK2830929A; Pneumococcal conjugate vaccine GSK2830930A; Synflorix™; Prevnar 13™; Infanrix hexa™
Intervention description: Intramuscular injection; Intramuscular injection; Intramuscular injection; Intramuscular injection; Intramuscular injection
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 953.0
Sex: All
Minimum age: 6 Weeks
Maximum age: 12 Weeks
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Streptococcus pneumoniae; Haemophilus influenzae; Pneumococcal vaccine; Infants; Safety; Immunogenicity

Summary:

      The purpose of this study is to assess the immunogenicity, reactogenicity and safety of two
      formulations of GSK Biologicals' pneumococcal vaccine (2830929A and 2830930A) administered as
      3-dose primary vaccination during the first 6 months of life followed by a booster dose in
      the second year of life. To comply with the routine infant immunisation program, the licensed
      GSK Biologicals DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine will be co-administered in infants
      with the pneumococcal study vaccines.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who the investigator believes that their parent(s)/Legally Acceptable
             Representative(s) (LARs) can and will comply with the requirements of the protocol.

          -  A male or female between, and including 6 to 12 weeks (42-90 days) of age at the time
             of the first vaccination. In addition, the first pneumococcal and DTPa-HBV-IPV/Hib
             vaccination should be given in accordance with the official national recommendations
             for the immunisation schedule of infants.

          -  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.

          -  Born after a gestation period of at least 36 weeks.

        Exclusion Criteria:

          -  Child in care.

          -  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 since
             birth.

          -  Planned administration/administration of a vaccine containing diphtheria toxoid,
             tetanus toxoid (except MenC-TT in Spain) or CRM197 and not foreseen by the study
             protocol during any time of the study period, or of any other vaccines not foreseen by
             the protocol in the period starting from 30 days before each dose and ending 30 days
             after each dose of vaccine(s), with the following exceptions:

               -  Licensed influenza vaccines are always allowed, even if concomitantly
                  administered with the study vaccines.

               -  Licensed rotavirus vaccines are allowed if administered at least 7 days before or
                  after each dose of study of vaccines.

               -  Licensed MenC-TT vaccine is allowed in Spain and should be concomitantly
                  administered with the study vaccine at around 2, 4 and 12-15 months of age.

               -  In case an emergency mass vaccination for an unforeseen public health threat
                  (e.g. a pandemic) is organised by the public health authorities, outside the
                  routine immunization program, that vaccine can be administered at any time during
                  the study period provided it is licensed and used according to its Summary of
                  Product Characteristics or Prescribing Information and according to the local
                  governmental recommendations.

          -  Concurrently participating in another clinical study, at any time during the study
             period, in which the subject has been or will be exposed to an investigational or a
             non-investigational product .

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
             medical history and physical examination.

          -  Family history of congenital or hereditary immunodeficiency.

          -  History of any reaction or hypersensitivity likely to be exacerbated by any component
             of the vaccine(s).

          -  Major congenital defects or serious chronic illness, including Kawasaki's syndrome.

          -  History of any neurological disorders or seizures, including conditions such as
             hypotensive-hyporesponsive episodes, encephalopathy and any convulsions (afebrile and
             febrile).

          -  Acute disease and/or fever at the time of enrolment.

          -  Administration of immunoglobulins and/or any blood products since birth or planned
             administration during study period.

          -  Previous vaccination against diphtheria, tetanus, pertussis, polio, H. influenzae type
             b.

          -  Previous vaccination against S. pneumoniae.

          -  History of or intercurrent diphtheria, tetanus, pertussis, hepatitis B, polio, H.
             influenzae type b disease.

          -  Any medical condition which might interfere with the assessment of the study
             objectives in the opinion of the investigator.