Safety and immunogenicity study of GlaxoSmithKline (GSK) Biologicals’ pneumococcal vaccine 2830930A when given as 1 dose to healthy toddlers aged 12-23 months.

• Conditions: 1-dose vaccination of healthy toddlers between 12-23 months of age at the time of vaccination against Streptococcus pneumoniae (S. pn) and Haemophilus influenzae (Hi) who previously received 3 doses of Synflorix.; MedDRA version: 14.0Level: LLTClassification code 10018953Term: Haemophilus influenzae meningitisSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 14.0Level: LLTClassification code 10042194Term: Streptococcus pneumoniae meningitisSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 14.0Level: LLTClassification code 10042196Term: Streptococcus pneumoniae secondary bacterial infection of acute bronchitisSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 14.0Level: LLTClassification code 10018954Term: Haemophilus influenzae secondary bacterial infection of acute bronchitisSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 14.0Level: LLTClassification code 10018952Term: Haemophilus influenzae infectionSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 14.0Level: LLTClassification code 10035680Term: Pneumonia due to Haemophilus influenzae (H. influenzae)System Organ Class: 10021881 - Infections and infestations; MedDRA version: 14.0Level: LLTClassification code 10054642Term: Streptococcus pneumoniae septicemiaSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 14.0Level: LLTClassification code 10042195Term: Streptococcus pneumoniae pneumoniaSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 14.0Level: LLTClassification code 10058214Term: Septicaemia due to haemophilus influenzae (H. influenzae)System Organ Class: 10021881 - Infections and infestations

• Registration Number: EUCTR2011-002225-22-DE
• Lead Sponsor: GlaxoSmithKline Biologicals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08-22
• Last Update Posted: 8 May 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

All subjects must satisfy ALL the following criteria at study entry:
• Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LARs) can and will comply with the requirements of the protocol.
• A male or female between, and including 12 to 23 months of age at the time of vaccination
• Written informed consent obtained from the parents/LAR(s) of the subject.
• 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.
• Previously completed three-dose vaccination course with Synflorix.
Are the trial subjects under 18? yes
Number of subjects for this age range: 60
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 vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
•Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
•Planned administration/administration of a vaccine containing diphtheria- or tetanus- toxoid or CRM197 and not foreseen by the study protocol during any time of the study period, or of any other vaccines not foreseen by the protocol in the period starting from 30 days before the vaccine dose and ending 30 days after, with the exception of licensed influenza vaccines
- The licensed influenza vaccines are always allowed, even if concomitantly administered with the study vaccines.
•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 immunodeficient condition, based on medical history and physical examination
•Family history of congenital or hereditary immunodeficiency.
•History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s).
•Major congenital defects or serious chronic illness, including Kawasaki's syndrome.
•History of any neurological disorders or seizures, including conditions such as hypotonic-hyporesponsive episodes, encephalopathy and any convulsions (afebrile and febrile).
•Acute disease and/or fever at the time of enrolment.
•Administration of immunoglobulins and/or any blood products within the 3 months preceding vaccination or planned administration during study period.
•Any medical condition which might interfere with the assessment of the study objectives in the opinion of the investigator.
•Previous receipt of a booster dose (fourth dose) of Synflorix.
•Anaphylaxis following previous administration of vaccines.

Study & Design

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