Primary Vaccination Study With a Pneumococcal Conjugate Vaccine in Healthy Children 6-12wks of Age
Condition: Infections, Streptococcal
MeSH terms: Streptococcal Infections
Intervention: Pneumococcal conjugate vaccine GSK1024850A (different lots); Infanrix hexa; Infanrix-IPV/Hib; Rotarix
Intervention description: Intramuscular injection, 3 doses; Intramuscular injection, 3 doses in Malaysia and 2 doses in Singapore; Intramuscular injection, only for Visit 2 in Singapore; Oral, 2 doses
Intervention MeSH terms: Vaccines; 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: 466.0
Sex: All
Minimum age: 6 Weeks
Maximum age: 12 Weeks
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Pneumococcal vaccine; Immunogenicity; Primary vaccination; Safety; Pneumococcal disease

Summary:

      The purpose of the present study is to demonstrate that the changes in the manufacturing
      process for the commercial lot of the pneumococcal conjugate vaccine GSK1024850A have no
      clinical impact and that the immune responses are non-inferior to the immune responses
      induced by the clinical lot. The study will be conducted in Singapore and Malaysia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subjects between, and including 6-12 weeks of age at the time of the
             first vaccination.

          -  Subjects for whom the investigator believes that their parent(s)/guardian(s) can and
             will comply with the requirements of the protocol.

          -  Written or oral, signed or thumb-printed informed consent obtained from the
             parent(s)/guardian(s) of the child/ward.

          -  Free of any known or suspected 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 product (drug or vaccine) other than the
             study vaccines within 30 days preceding the first dose of the study vaccines, or
             planned use during the study period.

          -  Concurrently participating in another clinical study, at any time during the study
             period.

          -  Chronic administration (defined as more than 14 days) of immunosuppressants or other
             immune-modifying drugs since birth.

          -  A family history of congenital or hereditary immunodeficiency.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition based on
             medical history and physical examination.

          -  Administration of immunoglobulins and/or any blood products since birth or planned
             administration during the study period (with the exception of hepatitis B
             immunoglobulins at birth).

          -  Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis
             B, Haemophilus influenzae type b and/or Streptococcus pneumoniae (with the exception
             of vaccines where the first dose can be given within the first two weeks of life).

          -  Planned administration/administration of a vaccine not foreseen by the study protocol
             during the period starting 30 days before each dose of vaccine and ending 7 days after
             Dose 1 and Dose 2 and 30 days after Dose 3.

          -  History of, or intercurrent diphtheria, tetanus, pertussis, hepatitis B,
             poliomyelitis, H. influenzae type b and rotavirus disease.

          -  History of allergic disease or reactions likely to be exacerbated by any component of
             the vaccines.

          -  History of any neurological disorders or seizures.

          -  Major congenital defects or serious chronic illness.

          -  Acute disease at the time of enrolment.

          -  Gastroenteritis within 7 days preceding the study vaccine administration.

          -  Any clinically significant history of chronic gastrointestinal disease including any
             uncorrected congenital malformation of the gastrointestinal tract, intussusception or
             other medical condition determined to be serious by the investigator.