A phase IIIb open, controlled study to evaluate the immunogenicity, safety and reactogenicity of GlaxoSmithKline (GSK) Biologicals’ 10-valent pneumococcal conjugate vaccine when given as a catch-up immunization in children older than 7 months of age or given as a 3-dose primary immunization in children before 6 months of age. - 10PN-PD-DIT-013

• Conditions: Catch-up immunization against Streptococcus pneumoniae in children older than 7 months at the time of the first vaccination and subdivided according to the age:•7 to 11 months of age.•12 to 23 months of age.•24 months to 5 years of age.

• Registration Number: EUCTR2006-001482-42-FI
• Lead Sponsor: GlaxoSmithKline Biologicals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-05-23
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

•Male or female between, and including
- 9-12 weeks (63 to 90 days) of age at the time of first vaccination for the <6 Mo group.
- 7-11 months of age at the time of first vaccination for the 7-11 Mo group.
- 12-23 months of age at the time of first vaccination for the 12-23 Mo group.
- 24 months to 5 years at the time of first vaccination for the =24 Mo group.
•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 cards, return for follow-up visits).
•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.
•Born after a gestation period between 36 and 42 weeks.

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 the first dose of study vaccine, or planned use during the entire study period for each age-group.
•Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. (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 and ending one month after each dose of vaccine(s).
•Previous vaccination against S. pneumoniae.
•History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, including diphtheria toxoid.
•History of seizures or neurological disease.
•Acute disease at the time of enrolment. (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 infections with or without low-grade fever, i.e oral/axillary/tympanic temperature <37.5°C / rectal temperature <38.0°C).
•Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing required).
•A family history of congenital or hereditary immunodeficiency.
•Major congenital defects or serious chronic illness.
•Administration of immunoglobulins and/or any blood products since birth or planned administration during the entire study period.

Study & Design

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