EUCTR2012-000819-82-Outside-EU/EEA
Active, not recruiting
Not Applicable
A phase III, multi-centre, open study to assess antibody persistence after completion of the 3-dose primary vaccination course with GlaxoSmithKline (GSK) Biologicals’ 10-valent pneumococcal conjugate vaccine in study 10PN-PD-DIT-048 (111654) in Singapore as well as the safety, reactogenicity and immunogenicity of GSK Biologicals’ 10-valent pneumococcal conjugate vaccine when given as a booster dose at 18-21 months of age. - 10PN-PD-DIT-049 BST:048
ConditionsHealthy volunteers (a single-dose booster vaccination against Streptococcus pneumoniae, diphtheria, tetanus, pertussis, poliomyelitis and Haemophilus influenzae type b diseases in healthy children 18 to 21 months of age, who were previously primed with three doses of GSK Biologicals’ 10-valent pneumococcal conjugate vaccine, co-administered with HRV and DTPa-combined vaccines)MedDRA version: 18.0Level: LLTClassification code 10042197Term: Streptococcus pneumoniae septicaemiaSystem Organ Class: 100000004862MedDRA version: 18.0Level: LLTClassification code 10042195Term: Streptococcus pneumoniae pneumoniaSystem Organ Class: 100000004862MedDRA version: 18.0Level: LLTClassification code 10054642Term: Streptococcus pneumoniae septicemiaSystem Organ Class: 100000004862MedDRA version: 18.0Level: LLTClassification code 10035648Term: Pneumococcal pneumonia [Streptococcus pneumoniae pneumonia]System Organ Class: 100000004862Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
DrugsSynflorix
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Healthy volunteers (a single-dose booster vaccination against Streptococcus pneumoniae, diphtheria, tetanus, pertussis, poliomyelitis and Haemophilus influenzae type b diseases in healthy children 18 to 21 months of age, who were previously primed with three doses of GSK Biologicals’ 10-valent pneumococcal conjugate vaccine, co-administered with HRV and DTPa-combined vaccines)
- Sponsor
- GlaxoSmithKline Biologicals
- Enrollment
- 238
- Status
- Active, not recruiting
- Last Updated
- 10 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects who the investigator believes that their par\-ent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol
- •Male or female between, and including, 18 and 21 months of age at the time of booster vaccination.
- •Subjects who received three doses of pneumococcal conjugate vaccine in study NCT00808444
- •Written informed consent obtained from the parents/LAR(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: 238
- •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
Exclusion Criteria
- •Use of any investigational or non\-registered product other than the study vaccine(s) within 30 days preceding 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 vac\-cination.
- •A family history of congenital or hereditary immunodeficiency.
- •Administration of immunoglobulins and/ or any blood products within the three months preceding vaccination or planned use during the study period.
- •Administration of any pneumococcal and/or vaccine containing diphtheria, tetanus, pertussis, poliomyelitis or Haemophilus influenzae type b antigens since the end of study NCT00808444\.
- •Planned administration/administration of a vaccine not foreseen by the study protocol during the study period starting from 30 days before booster vaccination and during the entire study period.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- •History of any reaction or allergic disease likely to be exacerbated by any component of the study vaccines.
- •Known hypersensitivity to any component of the study vaccines including anaphylactic reactions following the administration of the study vaccines.
Outcomes
Primary Outcomes
Not specified
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