A phase III long-term follow-up study to assess immunological memory induced following primary and booster vaccination with GSK Biologicals’ 10-valent pneumococcal conjugate vaccine (10Pn-PD-DiT), through evaluation of early antibody responses after an additional dose of 10Pn-PD-DiT at 40-48 months of age, to evaluate in the fourth year of life, the immunogenicity and safety of a 2-dose catch-up immunization course with the 10Pn-PD-DiT vaccine and the impact of pneumococcal vaccination on nasopharyngeal carriage. - 10PN-PD-DIT-042 EXT 014

Conditions: Subjects aged 31-44 months previously vaccinated with GSK Biologicals’ 10Pn-PD-DiT vaccine and age-matched unprimed children who participated in study 10PN-PD-DIT-014 (107137).

Registration Number: EUCTR2008-008104-41-CZ

Lead Sponsor: GlaxoSmithKline Biologicals

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 690

Inclusion Criteria

Subjects who the investigator believes that their parents/ guardians can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits) should be enrolled in the study.
A male or female between, and including, 31 and 44 months of age at the time of the enrolment.
Subjects who previously participated in study 10PN-PD-DIT-014 (107137):
*For the subjects in the primed AP-AP and NAP-pre groups: subjects who received a booster dose of the pneumococcal conjugate vaccine prior to the 10PN-PD-DIT-014 study amendment 3.
*For the subjects in the unprimed group: subjects who received a dose of the MenACWY-TT vaccine.
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.

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding enrolment, or planned use during the entire study period.
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs during the entire study period. (For corticosteroids, this will mean prednisone, or equivalent, >= 0.5 mg/kg/day. Inhaled and topical steroids are allowed).
Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of study vaccine and ending 30 days after.
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).
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
History of seizures (subjects who have had a single, uncomplicated febrile convulsion in the past can be included) or progressive neurological disease.
Acute disease at the time of enrolment, defined as the presence of a mild, moderate or severe illness with or without fever.
Administration or planned use of immunoglobulins and/ or any blood products during the entire study period.
A family history of congenital or hereditary immunodeficiency.
Major congenital defects or serious chronic illness.
Subjects of which both parents have a history of atopia (polinosis, asthma, atopic eczema).
Administration of any pneumococcal vaccine since the end of study 10PN-PD-DIT-014 (107137).