EUCTR2006-001934-42-FI进行中（未招募）不适用
A phase IIIa open, randomised, controlled study to assess the safety, reactogenicity and immunogenicity induced by a booster dose of GlaxoSmithKline (GSK) Biologicals 10-valent pneumococcal conjugate vaccine when co-administered with GSK Biologicals’ measles-mumps-rubella-varicella vaccine (MMRV) vaccine in children during their second year of life, previously vaccinated in infancy in the primary study 10PN-PD-DIT-001 (105553) with GSK Biologicals 10-valent pneumococcal conjugate vaccine. - 10PN-PD-DIT-022 BST: 001
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 400
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Male or female between, and including, ± 12-14 months of age at the time of first vaccination.
- •Subjects who previously participated in the study 10PN-PD-DIT-001 and received at least one dose of 10-valent pneumococcal conjugate vaccine during the primary study.
- •Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visit).
- •Written informed consent obtained from the parent or guardian 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:
- •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
排除标准
- •Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine(s), or planned use during the entire study period (active phase and extended safety follow-up).
- •Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. (For corticosteroids, this will mean prednisone, or equivalent, = 0.5 mg/kg/day. Inhaled and topical steroids are allowed.)
- •Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting one month before the first dose of vaccine(s) and ending 42-56 days after the last dose of vaccine(s).
- •Administration of any additional pneumococcal vaccine since end of 10PN-PD-DIT-001 study.
- •Previous vaccination against measles, mumps, rubella and/or varicella.
- •History of or intercurrent measles, mumps, rubella and/or varicella/zoster diseases.
- •Known exposure to measles, mumps, rubella and/or varicella/zoster within 30 days prior to study start.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing required).
- •A family history of congenital or hereditary immunodeficiency.
- •History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
- •Major congenital defects or serious chronic illness.
- •History of seizures (subjects who have had a single, uncomplicated febrile convulsion in the past can be included) or progressive neurological disease.
- •Administration of immunoglobulins and/or any blood products within the three months preceding the booster dose or planned administration during the active phase of the study.
- •Any known anaphylactic reaction from previous administration of vaccine(s).
- •Acute disease at the time of enrolment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhoea or mild upper respiratory infections with or without low-grade fever, i.e oral/axillary/tympanic temperature <37.5°C / rectal temperature <38.0°C).
- •Febrile illness defined as oral, axillary or tympanic temperature =37.5°C, 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.
- •Residence in the same household as a high risk person for varicella (i.e. susceptible to develop complications due to shedding of live varicella vaccine virus by the vaccinee) during the study period e.g.: new-born infants (0-4 weeks of age), pregnant women with a negative history of chickenpox disease and without recorded vaccination against chickenpox and persons with known immunodeficiency.
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