A phase III long-term follow-up study to assess the immune responses following vaccination at 36-46 months of age with a booster dose of GSK Biologicals’ 10-valent pneumococcal conjugate vaccine (10Pn-PD-DiT) and to evaluate the immunogenicity and safety of a 2-dose catch-up immunization course with the 10Pn-PD-DiT vaccine in the fourth year of life. - 10PN-PD-DIT-046 EXT:002 Y2

Phase 1

• Conditions: A booster vaccination study against Streptococcus pneumoniae in subjects aged 36-46 months and a two-dose vaccination against Streptococcus pneumoniae of age-matched unprimed children.

• Registration Number: EUCTR2008-003950-14-SK
• Lead Sponsor: GlaxoSmithKline Biologicals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09-25
• Last Update Posted: 13 March 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

Male or female between, and including, approximately 36-46 months of age at the time of vaccination.
For primed subjects: having completed the full vaccination course with the 10Pn-PD-DiT vaccine in study 10PN-PD-DIT-002 (105539).
Subjects for whom the investigator believes that their parent(s)/guardian(s) can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits).
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.

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) 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 6 months prior to the vaccination. (For corticosteroids, this will mean prednisone, or equivalent, equal or above 0.5 mg/kg/day. Inhaled and topical steroids are allowed.)
For primed subjects: administration of any pneumococcal vaccine since the end of study 10PN-PD-DIT-002 (105539).
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 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 reactions or allergic disease likely to be exacerbated by any component of the study vaccine.
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).

Study & Design

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