Primary and Booster Vaccination Study With a Pneumococcal Vaccine in HIV Infected, HIV Exposed Uninfected and HIV Uninfected Children 6 to 10 Weeks of Age.
Condition: Infections, Streptococcal
MeSH terms: Streptococcal Infections
Intervention: Pneumococcal vaccine GSK1024850A; Tritanrix-HepB/Hib; measles; Rotarix; Local OPV
Intervention description: Intramuscular injection, administered as 3 or 4 doses; Intramuscular injection, 4 doses; Intramuscular injection, 2 doses; Oral, 2 doses; Oral 4 doses. Given at any time during the study, routinely given concurrently with DTPw-HBV/Hib vaccine
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 489.0
Sex: All
Minimum age: 6 Weeks
Maximum age: 10 Weeks
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Human Immunodeficiency Virus; Booster vaccination; Safety; Primary vaccination; Pneumococcal vaccine; Immunogenicity; Pneumococcal disease

Summary:

      The purposes of this study:

        -  To evaluate the immunogenicity, safety and reactogenicity of pneumococcal vaccine
           GSK1024850A in HIV infected infants, HIV exposed uninfected infants and HIV unexposed
           uninfected infants following a 3-dose primary vaccination at 6, 10 and 14 weeks of age
           and following booster vaccination at 9-10 months of age.

        -  To evaluate the immunogenicity, safety and reactogenicity of pneumococcal vaccine
           GSK1024850A in HIV unexposed uninfected infants receiving either a 3-dose primary
           vaccination according to the EPI vaccination schedule at 6, 10 and 14 weeks of age with
           or without booster vaccination at 9-10 months of age or a 2-dose primary vaccination at
           6 and 14 weeks of age followed by booster vaccination at 9-10 months of age.

        -  This study also aims to assess the impact of the pneumococcal vaccine GSK1024850A on
           nasopharyngeal carriage of S. pneumoniae and H. influenzae up to 24 months of age in all
           study participants.
    

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 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).

        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.

          -  A family history of hereditary immunodeficiency other than HIV infection.

          -  Major congenital defects or serious chronic illness other than HIV infection.

          -  For HIV infected infants: Moderately and severely symptomatic: stages III and IV
             according to latest version of WHO classification.

          -  Administration of immunoglobulins and/or any blood products since birth or planned
             administration during the study period.

          -  Previous vaccination against diphtheria, tetanus, pertussis, hepatitis B, Haemophilus
             influenzae type b, and/or Streptococcus pneumoniae.

          -  History of, or intercurrent, diphtheria, tetanus, pertussis, 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.

          -  Acute disease at the time of enrolment.

          -  Babies for which weight for age is < 3rd percentile at Visit 1, using standard growth
             charts, with the exception of HIV infected infants for which the decision of enrolment
             was left to the investigator's discretion.

          -  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.

          -  Gastroenteritis within 7 days preceding the study vaccine administration (warrants
             deferral of vaccination).