Booster vaccination with pneumococcal vaccine GSK1024850A or Prevenar™ co-administered with Hiberix™ in children primed with the same vaccines.
- Conditions
- Healthy volunteers (Booster vaccination at 12-18 months of age against Streptococcus pneumoniae and Haemophilus influenzae type b in healthy children primed with the same study vaccines in study 10PN-PD-DIT-036 (110808))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
- EUCTR2015-001506-34-Outside-EU/EEA
- Lead Sponsor
- GlaxoSmithKline Biologicals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 448
• A male or female between, and including, 12-18 months of age at the time of booster vaccination.
• Subjects for whom the investigator believes that their parent(s)/ guardian(s) can and will comply with the requirements of the protocol.
• Subjects who received three doses of pneumococcal conjugate vaccine in study 10PN-PD-DIT-036 (110808).
• Written informed consent obtained from the parent(s)/guardian(s) of the child/ward.
• 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: 448
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 (drug or vaccine) 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 (pharmaceutical product or device).
• Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to vaccination.
• Administration of immunoglobulins and/or any blood products within three months preceding the vaccination or planned administration during the study period.
• Administration of any pneumococcal and/or Hib vaccine since the end of study 10PN-PD-DIT-036 (110808).
• Planned administration/administration of a vaccine not allowed by the study protocol during the period starting 1 month before the administration of the booster dose of the study vaccines and up to the follow-up visit with the exception of vaccines included in the Korean routine immunization schedule which can be given at least one week before the administration of the study vaccines or after study end.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
• History of reactions 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.
• Tympanic or axillary/ oral temperature >= 37.5°C or rectal temperature >= 38.0°C. A temperature greater than or equal to these cut-offs warrants deferral of the vaccination pending recovery of the subject.
• Acute disease at the time of enrolment.
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 reactogenicity of a booster dose of the 10Pn-PD-DiT vaccine in terms of the occurrence of adverse events with intensity grade 3, when co-administered with Hiberix at 12-18 months of age in children primed with the same vaccines at 2, 4 and 6 months of age in study 10PN-PD-DIT-036 (110808).;Secondary Objective: • To assess the safety and reactogenicity of a booster dose of the 10Pn-PD-DiT vaccine when co-administered with Hiberix at 12-18 months of age in children primed with the same vaccines at 2, 4 and 6 months of age in study 10PN-PD-DIT-036 (110808).<br>• To assess the immunogenicity of a booster dose of the 10Pn-PD-DiT vaccine when co-administered with Hiberix at 12-18 months of age in children primed with the same vaccines at 2, 4 and 6 months of age in study 10PN-PD-DIT-036 (110808).;Primary end point(s): Occurrence of grade 3 adverse events (solicited and unsolicited) ;Timepoint(s) of evaluation of this end point: Within 31 days (Day 0 - Day 30) after booster vaccination
- Secondary Outcome Measures
Name Time Method Timepoint(s) of evaluation of this end point: Solicited symptoms: Within 4 days (Days 0 to 3) after booster vaccination<br>Unsolicited AEs: Within 31 days (Days 0 to 30) after booster vaccination<br>SAEs: After booster vaccination up to study end <br>Immunogenicity endpoints: One month after booster vaccination;Secondary end point(s): • Occurrence of solicited local adverse events (any, grade 3)<br>• Occurrence of solicited general adverse events (any, grade 3, related)<br>• Occurrence of unsolicited adverse events (AEs)<br>• Occurrence of serious adverse events<br>• Concentrations of antibodies against vaccine pneumococcal serotypes<br>• Opsonophagocytic activity against vaccine pneumococcal serotypes<br>• Concentrations of antibodies against cross-reactive pneumo-coccal serotypes 6A and 19A<br>• Opsonophagocytic activity against cross-reactive pneumococcal serotypes 6A and 19A<br>• Concentrations of antibodies against protein D<br>• Antibody concentrations against polyribosyl-ribitol phosphate