Co-administration of Pneumococcal Conjugate Vaccine With DTPa-IPV-Hib Versus Co-administration With DTPa-HBV-IPV/Hib
Condition: Infections, Streptococcal
MeSH terms: Streptococcal Infections
Intervention: GSK Biologicals´ Pneumococcal Conjugate Vaccine GSK1024850A (Synflorix™); Infanrix™ hexa.; Pediacel™; Prevenar™
Intervention description: Intramuscular injection, 3 doses in the primary vaccination and 1 dose in the booster vaccination; Intramuscular injection, , 3 doses in the primary vaccination and 1 dose in the booster vaccination; Intramuscular injection, , 3 doses in the primary vaccination and 1 dose in the booster vaccination; Intramuscular injection, , 3 doses in the primary vaccination and 1 dose in the booster vaccination
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 780.0
Sex: All
Minimum age: 6 Weeks
Maximum age: 12 Weeks
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this trial is to evaluate the immunogenicity and safety of a pneumococcal
      conjugate vaccine when co-administered with DTPa-IPV-Hib or DTPa-HBV-IPV/Hib in infants as a
      three-dose primary immunisation course during the first 6 months of life and as a booster
      dose at 11-12 months of age. The impact of the pneumococcal conjugate vaccine on
      nasopharyngeal carriage of S. pneumoniae and H. influenzae in children in their first two
      years of life will also be assessed. The Protocol Posting has been updated in order to comply
      with the FDA Amendment Act, Sep 2007.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who the investigator believes that their parents/guardian(s) can and will
             comply with the requirements of the protocol (e.g., completion of the diary cards,
             return for follow-up visits) should be enrolled in the study.

          -  A male or female between, and including, 6-12 weeks (42-90 days) of age at the time of
             the first vaccination.

          -  Written informed consent obtained from both parents or from the guardian(s) 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 at least 36 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.

          -  Concurrently participating in another clinical study, at any time during the entire
             study period, in which the subject has been or will be exposed to an investigational
             or a non-investigational product (pharmaceutical product or device).

          -  Chronic administration (defined as more than 14 days) of immunosuppressants or other
             immune-modifying drugs since birth.

          -  Planned administration/administration of a vaccine not foreseen by the study protocol
             during the period starting from one month (30 days) before and up to one month (30
             days) after each dose of study vaccine.

          -  Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B,
             Haemophilus influenzae type b and/or Streptococcus pneumoniae.

          -  Children for whom hepatitis B vaccination is required according to the local
             recommendations

          -  History of or intercurrent diphtheria, tetanus, pertussis, hepatitis B, polio,
             Haemophilus influenzae type b disease.

          -  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.

          -  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.