Booster and Catch-up Vaccination With Vaccine GSK1024850A

• Conditions: Healthy volunteers (Vaccination against Streptococcus pneumoniae in healthy children previously enrolled in study 10PN-PD-DIT-037 (111188).); MedDRA version: 14.1Level: PTClassification code 10061353Term: Pneumococcal infectionSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 14.1Level: PTClassification code 10061190Term: Haemophilus infectionSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2011-002140-27-Outside-EU/EEA
• Lead Sponsor: GlaxoSmithKline Biologicals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04-12
• Last Update Posted: 18 April 2012

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 360

Inclusion Criteria

• Male or female subjects for whom the investigator believes that their parent(s)/ guardian(s) can and will comply with the requirements of the protocol.
•For primed subjects:
-Completion of the full vaccination course in study 10PN-PD-DIT-037 (111188).
-9-18 months at the time of randomization.
-9-18 months of age at the time of booster vaccination for the Pn-Pn9 group.
-15-18 months of age at the time of booster vaccination for the Pn-Pn15 group.
• For unprimed subjects:
-Enrolled in study 10PN-PD-DIT-037 (111188).
-12-18 months of age at the time of first vaccination in the present study.
• Written, signed or thumb-printed informed consent obtained from the parent(s)/guardian(s) of the child/ward. Where parent(s)/guardian(s) are illiterate, the consent form will be countersigned by a witness.
• 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: 360
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 within 30 days preceding the vaccination, or planned use during the study period.
• 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.
• Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to vaccination.
• Administration of any pneumococcal vaccine since the end of study 10PN-PD-DIT-037 (111188).
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
• Major congenital defects or serious chronic illness.
• History of any neurologic disorders or seizures.
• Acute disease at the time of enrolment.
• Administration of immunoglobulins and/or any blood products within three months preceding the vaccination or planned administration during the study period.

Study & Design

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