Primary Vaccination Study With a Pneumococcal Conjugate Vaccine in Healthy Children 6 to 10 Weeks of Age
Condition: Infections, Streptococcal; Streptococcus Pneumoniae
MeSH terms: Pneumonia, Pneumococcal; Streptococcal Infections
Intervention: Pneumococcal conjugate vaccine GSK1024850A; Tritanrix-HepB/Hib; Hiberix; Tritanrix-HepB
Intervention description: Intramuscular injection, 3 doses; Intramuscular injection, 3 doses; Intramuscular injection, 3 doses; Intramuscular injection, 3 doses
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: 360.0
Sex: All
Minimum age: 6 Weeks
Maximum age: 10 Weeks
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Pneumococcal disease; Pneumococcal vaccine; Safety; Primary vaccination; Immunogenicity

Summary:

      The purpose of this study is to assess the immunogenicity in terms of antibody response and
      the safety/reactogenicity in terms of solicited and unsolicited symptoms and serious adverse
      events following primary vaccination of Indian infants with pneumococcal conjugate vaccine
      GSK1024850A co-administered with a diphtheria, tetanus, whole cell pertussis (DTPw)-combined
      vaccine during the first 4 months of life. The study will be conducted in India.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subjects between, and including 6-10 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. Where parent(s)/guardian(s) are illiterate,
             the consent form will be countersigned by a witness.

          -  Free of any known or suspected health problems (as established by medical history and
             clinical examination before entering into the study).

        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, 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.

          -  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, hepatitis B, Haemophilus
             influenzae type b and/or Streptococcus pneumoniae (with the exception of hepatitis B
             vaccination at birth or at least 30 days before the subject's first study visit).

          -  History of, or intercurrent, diphtheria, tetanus, pertussis, hepatitis B,
             Streptococcus and Haemophilus influenzae type b 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.

          -  Babies for which birth weight is < 2 kilogram.