Safety & Immunogenicity of Pneumococcal Vaccine 2189242A Co-administered With DTPa-HBV-IPV/Hib in Healthy Infants
Condition: Infections, Streptococcal
MeSH terms: Streptococcal Infections
Intervention: Pneumococcal vaccine GSK 2189242A (LD formulation 1); Pneumococcal vaccine GSK 2189242A (HD formulation 2); Synflorix; Prevenar 13; Infanrix Hexa (DTPa-HBV-IPV/Hib)
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: Double (Participant, Investigator)
Enrollment: 576.0
Sex: All
Minimum age: 6 Weeks
Maximum age: 14 Weeks
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Haemophilus influenzae; Streptococcus pneumoniae; immunogenicity; Pneumococcal vaccine; infants; safety

Summary:

      This study will assess the safety, reactogenicity and immunogenicity of two formulations of
      GSK Biologicals' pneumococcal vaccine 2189242A given as a 3-dose primary vaccination course
      during the first 6 months of life followed by a booster dose at 12-15 months of age and
      co-administered with DTPa-HBV-IPV/Hib vaccine.
    

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, 6 and 14 weeks (42-104 days) 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.

          -  Born after a gestation period of 36 to 42 weeks inclusive.

        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 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), with the exception of licensed flu vaccines.

          -  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.

          -  Previous vaccination against S. pneumoniae since birth.

          -  History of any reaction or hypersensitivity likely to be exacerbated by any component
             of the vaccine(s).

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
             medical history and physical examination.

          -  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 >= 38.0°C on rectal setting or >= 37.5°C on oral or
             axillary 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 since birth or planned
             administration during the primary epoch and during the period starting three months
             before booster vaccination and ending one month after the booster vaccination.