Vaccination Course in Primed Children and Age-matched Unprimed Children With Pneumococcal Vaccine GSK1024850A

• Immune responses (= antibody concentrations) against components of the investigational pneumococcal conjugate vaccine [ Time Frame: Prior to immunization (day 0) ] [ Designated as safety issue: No ]
• Immune responses (= antibody concentrations) against components of the investigational pneumococcal conjugate vaccine. [ Time Frame: 7-10 days after immunization or the first vaccine dose ] [ Designated as safety issue: No ]
• Immune responses (= antibody concentrations) against components of investigational pneumococcal conjugate vaccine [ Time Frame: Prior to immunization and 7-10 days after immunization or the first vaccine dose ] [ Designated as safety issue: No ]
• In a subset of subjects: immune responses (= antibody concentrations) against components of the investigational pneumococcal conjugate vaccine [ Time Frame: One month after the second vaccine dose (month 3) ] [ Designated as safety issue: No ]
• Occurrence of solicited adverse events [ Time Frame: Within 4 (day 0-3) days after vaccination ] [ Designated as safety issue: No ]
• Occurrence of unsolicited adverse events [ Time Frame: Within 31 (day 0-30) days after vaccination ] [ Designated as safety issue: No ]
• Occurrence of serious adverse events [ Time Frame: Following vaccination (day 0) and throughout the entire study period (until Month 1 or Month 3) ] [ Designated as safety issue: No ]

• Immune responses against components of the investigational pneumococcal conjugate vaccine [ Time Frame: Prior to immunization ] [ Designated as safety issue: No ]
• Immune responses against components of the investigational pneumococcal conjugate vaccine [ Time Frame: 7-10 days after immunization or the first vaccine dose ] [ Designated as safety issue: No ]
• Immune responses against components of the investigational pneumococcal conjugate vaccine [ Time Frame: Prior to immunization and 7-10 days after immunization or the first vaccine dose ] [ Designated as safety issue: No ]
• In a subset of subjects: immune responses against components of the investigational pneumococcal conjugate vaccine [ Time Frame: One month after the second vaccine dose ] [ Designated as safety issue: No ]
• Occurrence of solicited adverse events [ Time Frame: Within 4 days after vaccination ] [ Designated as safety issue: Yes ]
• Occurrence of unsolicited adverse events [ Time Frame: Within 31 days after vaccination ] [ Designated as safety issue: Yes ]
• Occurrence of serious adverse events [ Time Frame: Following vaccination and throughout the entire study period. ] [ Designated as safety issue: Yes ]

The purpose of this study is to assess the immune memory induced by primary and booster vaccination with pneumococcal conjugate vaccine GSK1024850A in the first year of life through evaluation of the immune responses following vaccination with a booster dose of pneumococcal conjugate vaccine GSK1024850A in the fourth year of life and to assess immune responses following vaccination with a single dose of pneumococcal conjugate vaccine GSK1024850A in age-matched unprimed children.

The study also aims to assess the antibody persistence in the fourth year of life following primary and booster vaccination with pneumococcal conjugate vaccine GSK1024850A in the first year of life.

The study is also designed to evaluate the immunogenicity in terms of antibody response and the safety/reactogenicity in terms of solicited and unsolicited symptoms and serious adverse events following a 2-dose vaccination with pneumococcal conjugate vaccine GSK1024850A in the fourth year of life.

This protocol posting deals with objectives & outcome measures of the booster phase. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT number = 00307034)

• Biological: Pneumococcal conjugate vaccine GSK1024850A
  Intramuscular injection, 1 dose
• Biological: Pneumococcal conjugate vaccine GSK1024850A
  Intramuscular injection, 2 doses

• Experimental: Group A
  Subjects previously vaccinated with pneumococcal conjugate vaccine GSK1024850A according to a 2+1 schedule in the first year of life receiving a booster dose of GSK1024850A in the fourth year of life.
  Intervention: Biological: Pneumococcal conjugate vaccine GSK1024850A
• Experimental: Group B
  Subjects previously vaccinated with pneumococcal conjugate vaccine GSK1024850A according to a 3+1 schedule in the first year of life receiving a booster dose of GSK1024850A in the fourth year of life.
  Intervention: Biological: Pneumococcal conjugate vaccine GSK1024850A
• Active Comparator: Group C
  Age-matched unprimed subjects receiving 2 doses of pneumococcal conjugate vaccine GSK1024850A in the fourth year of life.
  Intervention: Biological: Pneumococcal conjugate vaccine GSK1024850A

• Silfverdal SA et al. Assessment of immunological memory following PHiD-CV immunisation according to 2+1 or 3+1 schedules in the first year of life. Abstract presented at the 7th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD). Tel Aviv, Israel, 14-18 March 2010.
• Silfverdal SA et al. (2011) Anamnestic immune response in 3- to 4-year-old children previously immunized with 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine as 2 dose or 3 dose priming and a booster dose in the first year of life. Pediatr Infect Dis J. 30(9):155-163.
• Silfverdal SA, Skerlikova H, Zanova M, Papúchová D, Traskine M, Borys D, Schuerman L. Anamnestic immune response in 3- to 4-year-old children previously immunized with 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine as 2-dose or 3-dose priming and a booster dose in the first year of life. Pediatr Infect Dis J. 2011 Sep;30(9):e155-63.

Inclusion Criteria:

• Male or female between, and including, +- 36-46 months of age at the time of vaccination.
• For primed subjects: having completed the full vaccination course with GSK1024850A in the primary study (NCT00307034).
• 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 subject.
• Free of obvious 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.
• Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 6 months prior to vaccination.
• For primed subjects: administration of any pneumococcal vaccine since the end of the primary study (NCT00307034).
• For unprimed subjects: previous vaccination with any pneumococcal vaccine.
• Administration of immunoglobulins and/or any blood products less than 6 months prior to the vaccination or planned administration during the study period.
• Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
• History of reactions or allergic disease likely to be exacerbated by any component of the study vaccine.
• Acute disease at the time of enrolment.