Two-dose primary vaccination with either GSK Biologicals' 10-valent pneumococcal vaccine (Synflorix) or Pfizer’s Prevenar 13™ or both vaccines followed by a booster dose of Synflorix.

• Conditions: Healthy volunteers (Two-dose primary vaccination of healthy infants 6-12 weeks of age at the time of first vaccination against S. pneumoniae and H. influenzae according to a 2 months interval schedule followed by booster vaccination at 12-15 months of age); MedDRA version: 18.0Level: LLTClassification code 10042197Term: Streptococcus pneumoniae septicaemiaSystem Organ Class: 100000004862; MedDRA version: 18.0Level: LLTClassification code 10042195Term: Streptococcus pneumoniae pneumoniaSystem Organ Class: 100000004862; MedDRA version: 18.0Level: LLTClassification code 10054642Term: Streptococcus pneumoniae septicemiaSystem Organ Class: 100000004862; MedDRA version: 18.0Level: LLTClassification code 10035648Term: Pneumococcal pneumonia [Streptococcus pneumoniae pneumonia]System Organ Class: 100000004862; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2013-003479-36-Outside-EU/EEA
• Lead Sponsor: GlaxoSmithKline Biologicals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05-20
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 457

Inclusion Criteria

• Subjects who the investigator believes that par-ent(s)/Legally Acceptable Representative(s) [LAR(s)] can and will comply with the requirements of the protocol
• A male or female between, and including, 6-12 weeks of age at the time of the first vaccination.
• Healthy subjects as established by medical history and clinical examination before entering into the study.
• Born after a gestation period of at least 36 weeks.
• Written informed consent obtained from the par-ent(s)/LAR(s) of the subject.
Are the trial subjects under 18? yes
Number of subjects for this age range: 457
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

• Child in care.
• Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccines, or planned use during the entire study period.
• Chronic administration of immunosuppressants or other immune-modifying drugs since birth or planned use during the study.
• 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.
• Any confirmed or suspected immunosuppressive or im-munodeficient condition, based on medical history and physical examination.
• History of any reaction or hypersensitivity likely to be exacerbated by any component of the study vaccine.
• Major congenital defects or serious chronic illness.
• History of any seizures or progressive neurological dis-ease.
• Administration of immunoglobulins and/or blood products since birth or planned use during the study.
• Acute disease and/or fever at the time of enrolment.
• Previous vaccination or planned vaccination during the study with any pneumococcal vaccine.

Study & Design

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