Primary Vaccination Study With a Pneumococcal Conjugate Vaccine in Healthy Children 6 to 12wks of Age
Condition: Infections, Streptococcal; Streptococcus Pneumoniae Vaccines
MeSH terms: Pneumonia, Pneumococcal; Streptococcal Infections
Intervention: Synflorix; Infanrix hexa; Rotarix
Intervention description: Intramuscular injection, 3 doses.; Intramuscular injection, 3 doses.; Oral, 2 doses.
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 230.0
Sex: All
Minimum age: 6 Weeks
Maximum age: 12 Weeks
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Primary vaccination; Safety; Pneumococcal vaccine.; Pneumococcal disease; 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 Mexican infants with pneumococcal conjugate vaccine
      GSK 1024850A co-administered with a diphtheria, tetanus, acellular pertussis (DTPa)-combined
      vaccine (Infanrix hexa) and rotavirus vaccine (Rotarix) in children during the first 6 months
      of age.
    

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 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 of 36 to 42 weeks inclusive.

        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.

          -  Planned administration/administration of a vaccine not foreseen by the study protocol
             during the period starting one month before each dose of vaccines and ending 7 days
             after dose 1 and dose 2 and one month after dose 3.

          -  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.

          -  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.

          -  Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B,
             Haemophilus influenzae type b, rotavirus and/or Streptococcus pneumoniae; with the
             exception of vaccines where the first dose may be given at birth within the first two
             weeks of life according to national recommendations (e.g. Hepatitis B and BCG).

          -  History of, or intercurrent, diphtheria, tetanus, pertussis, polio, hepatitis B and
             Haemophilus influenzae type b disease.

          -  Gastroenteritis within 7 days preceding the study vaccine administration (warrants
             deferral of the vaccination).

          -  Any clinically significant history of chronic gastrointestinal disease including any
             uncorrected congenital malformation of the gastrointestinal (GI) tract,
             intussusception (IS) or other medical condition determined to be serious by the
             investigator.

          -  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.