Safety and Immunogenicity Study of GlaxoSmithKline (GSK) Biologicals' 10-valent Pneumococcal Conjugate Vaccine
Condition: Infections, Streptococcal
MeSH terms: Streptococcal Infections
Intervention: Pneumococcal conjugate vaccine GSK1024850A; Prevenar; Tritanrix-HepB; Hiberix; Polio Sabin.; Poliorix.
Intervention description: 3 Intramuscular injections.; 3 Intramuscular injections; 3 Intramuscular injections; Reconstituted with Tritanrix before injection; 3 oral doses.; 3 intramuscular injections
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Enrollment: 806.0
Sex: All
Minimum age: 6 Weeks
Maximum age: 12 Weeks
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Immunogenicity; Safety; Pneumococcal vaccine; Pneumococcal disease

Summary:

      This study will evaluate safety, reactogenicity and immunogenicity of GSK Biologicals'
      pneumococcal conjugate vaccine compared to Prevenar™ when co-administered with DTPw-HBV/Hib
      and OPV or IPV vaccines, according to 2 different schedules: 6-10-14 weeks or 2-4-6 months of
      age.

      The study has 2 groups.

        -  One group of subjects will receive a 3-dose primary vaccination with the GSK
           Biologicals' pneumococcal conjugate vaccine (three different lots will be used and
           randomly allocated).

        -  The 2nd group of subjects will receive a 3-dose primary vaccination with Prevenar™.

      All children will receive concomitantly DTPw-HBV/Hib and OPV or IPV vaccines. This protocol
      posting deals with objectives & outcome measures of the primary study. The objectives &
      outcome measures of the Booster study are presented in a separate protocol posting (NCT
      number =00547248).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female between, and including, 6-12 weeks (42 to 90 days) of age at the time
             of the first vaccination.

          -  Subjects for whom the investigator believes that their parents/guardians can and will
             comply with the requirements of the protocol

          -  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 between 36 and 42 weeks.

        Exclusion Criteria:

          -  Use of any investigational or non-registered product (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

          -  Chronic administration (defined as more than 14 days) of immunosuppressants or other
             immune-modifying drugs within six months prior to the first vaccine dose.

          -  Planned administration/ administration of a vaccine not foreseen by the study protocol
             during the period starting one month before each dose of vaccine(s) and ending 7 days
             after dose 1 and dose 2 or 1 month after dose 3.

          -  Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B,
             Haemophilus influenzae type b, and/or S. pneumoniae with the exception of vaccines
             where the first dose can be given within the first two weeks of life according to the
             national recommendations

          -  History of or intercurrent diphtheria, tetanus, pertussis, hepatitis B, polio, and
             Haemophilus influenzae type b diseases.

          -  History of allergic disease or reactions likely to be exacerbated by any component of
             the vaccines.

          -  History of seizures (this criterion does not apply to subjects who have had a single,
             uncomplicated febrile convulsion in the past) or neurological disease.

          -  Acute disease at the time of enrolment

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition based on
             medical history and physical

          -  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 active phase of the study.