Evaluation of immunological persistence following 3-dose priming with GSK Biologicals’ 10-valent pneumococcal conjugate vaccine in study 111654 and safety and immunogenicity following a booster dose of the same vaccine.
- 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)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]
- Registration Number
- EUCTR2012-000819-82-Outside-EU/EEA
- Lead Sponsor
- GlaxoSmithKline Biologicals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 238
• 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
F.1.3.1 Number of subjects for this age range
• 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.
• Major congenital defects or serious chronic illness.
• History of any neurologic disorders or seizures. (Subjects who have had a single uncomplicated febrile convulsion in the past can be included)
• Fever at the time of vaccination.
• Acute disease at the time of enrolment.
• Child in care.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the antibody persistence induced by the GSK Biologicals’ 10-valent pneumococcal conjugate vaccine (commercial lot versus phase III clinical lot), when co-administered with DTPa-IPV/Hib 13-16 months after completion of the 3-dose primary vaccination course in study 10PN-PD-DIT-048 (111654);Secondary Objective: • To assess the safety and reactogenicity of a booster dose of the 10Pn-PD-DiT vaccine (commercial lot), when co-administered with DTPa-IPV/Hib at 18-21 months of age in children primed at 2, 3 and 5 months of age in study 10PN-PD-DIT-048 (111654).<br>• To assess the immunogenicity of a booster dose of the 10Pn-PD-DiT vaccine (commercial lot), when co-administered with DTPa-IPV/Hib at 18-21 months of age in children primed at 2, 3 and 5 months of age in study 10PN-PD-DIT-048 (111654).;Primary end point(s): Evaluation of the immune response to components of the investigational vaccine;Timepoint(s) of evaluation of this end point: Before booster vaccination
- Secondary Outcome Measures
Name Time Method Timepoint(s) of evaluation of this end point: • Within 4 days (Day 0-3) after booster vaccination<br>• Within 31 days (Day 0-30) after booster vaccination<br>• From the booster vaccination up to study end <br>• Before and one month after booster vaccination;Secondary end point(s): • Occurrence of each solicited local and general adverse events<br>• Occurrence of unsolicited adverse events<br>• Occurrence of serious adverse events <br>• Evaluation of the immune response to components of the investigational vaccine for additional parameters and evaluation of the immune response to components of the co-administered vaccine