Immunological Persistence After Priming With GSK1024850A Vaccine and Safety& Immunogenicity After Booster Dose
Condition: Infections, Streptococcal
MeSH terms: Streptococcal Infections
Intervention: Pneumococcal vaccine GSK1024850A; Infanrix-IPV/Hib
Intervention description: Intramuscular injection, one dose; Intramuscular injection, one dose
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 238.0
Sex: All
Minimum age: 18 Months
Maximum age: 21 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: safety; Streptococcus pneumoniae; immunogenicity; Pneumococcal conjugate vaccine; Haemophilus influenzae

Summary:

      This primary purpose of this study is the evaluation of the immunological persistence
      following completion of the 3-dose primary vaccination course with either a clinical or a
      commercial lot of pneumococcal conjugate vaccine GSK1024850A in study NCT00808444. In
      addition, the study will also assess the safety, reactogenicity and immunogenicity of a
      fourth dose of pneumococcal conjugate vaccine GSK1024850A (commercial lot) when
      co-administered with Infanrix-IPV/Hib at 18-21 months of age in children primed in study
      NCT00808444.

      The primary vaccination study was conducted in Malaysia and Singapore. The booster
      vaccination study will not be performed in Malaysia since the pneumococcal conjugate vaccine
      GSK1024850A has been registered in September 2009. However, subjects in Malaysia will be
      offered a booster dose of the commercial pneumococcal conjugate vaccine licensed in Malaysia
      and Infanrix-IPV/Hib vaccine during the second year of life according to the nationally
      recommended regimen. Administration of the booster dose will be outside the set-up of a
      clinical trial. Hence no data will be collected, no blood samples will be taken in Malaysia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who the investigator believes that their parent(s)/Legally Acceptable
             Representative(s) (LAR) can and will comply with the requirements of the protocol

          -  Male or female between, and including, 18 and 21 months of age at the time of booster
             vaccination.

          -  Subjects who received three doses of pneumococcal conjugate vaccine in study
             NCT00808444

          -  Written informed consent obtained from the parents/LAR(s) of the subject.

          -  Healthy subjects as established by medical history and clinical examination before
             entering into the study.

        Exclusion Criteria:

          -  Use of any investigational or non-registered product other than the study vaccine(s)
             within 30 days preceding vaccination, 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.

          -  Chronic administration of immunosuppressants or other immune-modifying drugs within
             six months prior to vaccination.

          -  A family history of congenital or hereditary immunodeficiency.

          -  Administration of immunoglobulins and/ or any blood products within the 3 months
             preceding vaccination or planned use during the study period.

          -  Administration of any pneumococcal and/or vaccine containing diphtheria, tetanus,
             pertussis, poliomyelitis or Haemophilus influenzae type b antigens since the end of
             study NCT00808444.

          -  Planned administration/administration of a vaccine not foreseen by the study protocol
             during the study period starting from 30 days before vaccination and ending 30 days
             after vaccination.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
             medical history and physical examination (no laboratory testing required).

          -  History of any reaction or allergic disease likely to be exacerbated by any component
             of the study vaccines.

          -  Known hypersensitivity to any component of the study vaccines including anaphylactic
             reactions following the administration of the study vaccines.

          -  Major congenital defects or serious chronic illness.

          -  History of any neurologic disorders or seizures. (Subjects who have had a single
             uncomplicated febrile convulsion in the past can be included)

          -  Fever at the time of vaccination.

               -  Fever is defined as rectal temperature >= 38.0°C or tympanic/axillary/ oral
                  temperature >= 37.5°C.

          -  Acute disease at the time of enrolment.

               -  Subjects with a minor illness without fever may be enrolled at the discretion of
                  the investigator.

          -  Child in care.