A phase III, open, multicentre, extension study to assess the immune response following administration of an additional dose of GSK Biologicals’ 10-valent conjugate pneumococcal vaccine or Prevenar™ at approximately 4 years of age in children previously vaccinated with three primary doses of a pneumococcal conjugate vaccine in study 10PN-PD-DIT-003 (105554) and a booster dose of 23-valent pneumococcal plain polysaccharide vaccine in study 10PN-PD-DIT-008 BST: 003 (106623). - 10PN-PD-DIT-061 EXT: 008 Y4

• Conditions: A single dose of either 10Pn-PD-DiT or Prevenar vaccine to healthy children previously primed with 3 primary doses of 10Pn-PD-DiT or Prevenar vaccine in study 10PN-PD-DIT-003 (105554) and a booster dose of Pneumovax 23 (23vPS) vaccine in study 10PN-PD-DIT-008 BST: 003 (106623).

• Registration Number: EUCTR2008-007605-37-DE
• Lead Sponsor: GlaxoSmithKline Biologicals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03-04
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

•Male or female between, and including, 46-50 months of age at the time of vaccination.
•Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (e.g., completion of the diary card, return for the follow-up visit).
•Subjects who previously participated in the 10PN-PD-DIT-008 BST: 003 study in centres with more than 2 subjects and received a booster dose of 23vPS vaccine.
•Written informed consent obtained from both parents/guardians of the subject.
•Healthy subjects 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(s) within 30 days preceding the vaccination, or planned use during the study period.
•Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the vaccination. (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 one month before study vaccination and during the entire study period.
•Administration of any pneumococcal vaccine since the end of study 10PN-PD-DIT-008 BST: 003 (106623).
•Administration of immunoglobulins and/or any blood products less than 3 months prior to the vaccination or planned use during the study period.
•Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
•History of any neurologic disorders or seizures (subjects who have had a single, uncomplicated febrile convulsion in the past can be included).
•Anaphylactic reaction following previous administration of the vaccine or history of reactions or allergic disease likely to be exacerbated by any component of the vaccine.
•History of hypotonic-hyporesponsive episode after any previous vaccination.
•Major congenital defects or serious chronic illness.
•History of invasive pneumococcal diseases.
•Acute disease at the time of vaccination (Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhoea or mild upper respiratory infection, provided the body temperature is <38°C (rectal measurement) or <37.5°C (for oral/axillary/tympanic measurements). Study entry should be delayed until the illness has improved).
•Rectal temperature = 38.0°C or oral/axillary/tympanic temperature = 37.5°C. A temperature greater than or equal to these cut-offs warrants deferral of the vaccination pending recovery of the subject.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified