Safety & Immunogenicity Study of 10-Valent Pneumococcal Conjugate Vaccine When Administered as a 2-Dose Schedule
Condition: Infections, Streptococcal
MeSH terms: Streptococcal Infections
Intervention: GSK Biologicals' 10-valent pneumococcal conjugate vaccine.; Infanrix hexa.; Infanrix-IPV/Hib.
Intervention description: Intramuscular injection, 3 or 4 doses (2-4-11 or 2-3-4-11 months of age schedule).; Intramuscular injection, 3 doses (2-4-11 months of age schedule).; Intramuscular injection, 3 doses (2-4-11 months of age schedule).
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 351.0
Sex: All
Minimum age: 8 Weeks
Maximum age: 16 Weeks
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Primary vaccination; Pneumococcal disease; Safety; Booster vaccination; Immunogenicity; Pneumococcal vaccine; Dose comparison

Summary:

      Assess immuno, reacto of the 10-valent pneumococcal vaccine after 2 doses (2, 4 months of
      age) and after the complete 2, 4, 11 months schedule when co-administered with
      DTPa-HBV-IPV/Hib or DTPa-IPV/Hib (according to national recommendations)
    

Eligibility criteria:

        Inclusion criteria:

          -  Subjects for whom the investigator believes that their parents/guardians can and will
             comply with the requirements of the protocol.

          -  A male or female between, and including, 8 and 16 weeks (56-120 days) of age at the
             time of the first vaccination.

          -  Written informed consent obtained from the parent or guardian of the subject.

          -  Free of obvious health problems as established by medical history and clinical
             examination before entering into the study.

          -  Born after a gestation period of 36 to 42 weeks.

        Exclusion criteria:

          -  Use of any investigational or non-registered drug or vaccine other than the study
             vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use
             during the study period.

          -  Planned administration/ administration of a vaccine not foreseen by the study protocol
             during the period starting 30 days before the first dose of vaccine(s) and ending 30
             days after the last dose, with exception of BCG vaccination which can be given after
             the 1 month post-dose 2 or 3 (2-4-11 or 2-3-4-11 months of age schedule) blood
             sampling and a minimum of 30 days before the pre-booster dose blood sampling.

          -  Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B,
             Haemophilus influenzae type b, and/or S. pneumoniae.

          -  History of or intercurrent diphtheria, tetanus, pertussis, hepatitis B, polio,
             Haemophilus influenzae type b disease, and/or invasive pneumococcal diseases.

          -  History of allergic disease or reactions likely to be exacerbated by any component of
             the vaccines.

          -  History of any neurologic disorders or seizures.

          -  Acute disease at the time of enrolment.

          -  Chronic administration (defined as more than 14 days) of immunosuppressants or other
             immune-modifying drugs since birth.

          -  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 serious chronic illness.

          -  Administration of immunoglobulins and/or any blood products since birth or planned
             administration during the study period.