Primary Vaccination With Either Synflorix™ or Prevenar 13™ or Both Vaccines and Booster Vaccination With Synflorix™
Condition: Infections, Streptococcal; Streptococcus Pneumoniae Vaccines
MeSH terms: Pneumonia, Pneumococcal; Streptococcal Infections
Intervention: Synflorix (3-Dose); Synflorix (2-Dose); Synflorix (Single Dose); Prevenar 13 (Single Dose); Prevenar 13 (2-Dose)
Intervention description: 3 doses administered intramuscularly; 2 doses administered intramuscularly; 1 dose administered intramuscularly; 1 dose administered intramuscularly; 2 doses administered intramuscularly
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 457.0
Sex: All
Minimum age: 6 Weeks
Maximum age: 12 Weeks
Healthy volunteers: Accepts Healthy Volunteers
Keywords: pneumococcal conjugate vaccine; Synflorix; Prevnar 13; Pneumococcal diseases

Summary:

      The primary aim of this study is to assess the reactogenicity of Synflorix vaccine and
      Prevenar 13 vaccine after primary vaccination at 2 and 4 months of age with either Synflorix
      or Prevenar 13 vaccine or Prevenar 13 and Synflorix, respectively. In addition, this study
      aims at assessing the safety, reactogenicity, immunogenicity and antibody persistence
      (approximately 8-11 months following primary vaccination) of the Synflorix vaccine and
      Prevenar 13 vaccine after primary vaccination at 2 and 4 months of age with either Synflorix
      or Prevenar 13 vaccine or Prevenar 13 and Synflorix, respectively. This study also aims at
      assessing the safety, reactogenicity and immunogenicity of the Synflorix vaccine when given
      as a booster dose at 12-15 months of age following primary vaccination at 2 and 4 months of
      age with either Synflorix vaccine or Prevenar 13 vaccine or Prevenar 13 and Synflorix
      respectively.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who the investigator believes that parent(s)/Legally Acceptable
             Representative(s) [LAR(s)] can and will comply with the requirements of the protocol.

          -  A male or female between, and including, 6-12 weeks of age at the time of the first
             vaccination.

          -  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.

          -  Written informed consent obtained from the parent(s)/LAR(s) of the subject.

        Exclusion Criteria:

          -  Child in care.

          -  Use of any investigational or non-registered product other than the study vaccines
             within 30 days preceding the first dose of study vaccines, or planned use during the
             entire study period.

          -  Chronic administration of immunosuppressants or other immune-modifying drugs since
             birth or planned use during the study.

          -  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.

          -  History of any reaction or hypersensitivity likely to be exacerbated by any component
             of the study vaccine.

          -  Major congenital defects or serious chronic illness.

          -  History of any seizures or progressive neurological disease.

          -  Administration of immunoglobulins and/or blood products since birth or planned use
             during the study.

          -  Acute disease and/or fever at the time of enrolment.

          -  Previous vaccination or planned vaccination during the study with any pneumococcal
             vaccine.