EUCTR2006-000560-93-DE进行中（未招募）不适用
A phase IIIa, open, multicentre study to evaluate the immunological memory induced in healthy children following a 3-dose primary vaccination with either GSK Biologicals’ 10-valent pneumococcal conjugate vaccine or PrevenarTM in study 10PN-PD-DIT-003 (105554), via the administration of a single booster dose of a 23-valent pneumococcal plain polysaccharide vaccine. - 10PN-PD-DIT-008
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
- 120
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
- •All subjects must satisfy the following criteria at study entry:
- •Male or female between, and including, 11-14 months of age at the time of vaccination.
- •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 visits).
- •A male or female who previously participated in study 10PN-PD-DIT-003 and received the full three doses of pneumococcal conjugate vaccine.
- •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
- •The following criteria should be checked at the time of study entry. If any apply, the subject must not be included in the study:
- •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, or planned use during the study period.
- •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, greater or equal to 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 during the entire study period; with the exception of GSK Biologicals’ DTPa-HBV-IPV/Hib vaccine (Infanrix™ hexa) which may be administered concomitantly to Pneumovax™ 23 at 11-14 months of age.
- •Administration of any pneumococcal vaccine other than the study vaccines from study 10PN-PD-DIT-003.
- •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.
- •Anaphylactic reaction following the administration of the vaccine or history of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- •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.
- •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 diarrhea or mild upper respiratory infections with or without low-grade febrile illness, i.e oral/axillary/tympanic temperature <37.5°C / rectal temperature <38.0°C).
- •History of invasive pneumococcal diseases.
- •Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- •Febrile illness defined as oral, axillary or tympanic temperature greater or equal to 37.5°C, rectal temperature greater or equal to 38.0°C. A temperature greater than or equal to these cut-offs warrants deferral of the vaccination pending recovery of the subject.
- •Pneumovax™ 23
- •Hypersensitivity to any component of the vaccine. In the case of fever, acute disease, or relapse of chronic disease, it is preferable to postpone vaccination.
- •DTPa-HBV-IPV/Hib vaccine
- •The following adverse events constitute absolute contraindications to administration of DTPa-HBV-IPV/Hib; if any of these adverse events occur during the study, the investigator must decide which vaccine to give to the subject for these antigens:
- •DTPa-HBV-IPV/Hib should not be administered to subjects with known hypersensitivity after previous administration of diphtheria, tetanus, pertussis, hepatitis B and Hib vaccines or to any component of the vaccines.
- •DTPa-HBV-IPV/Hib are contra-indicated if the infant has experienced an encephalopathy, defined as an acute, severe central nervous system disorder occurring within 7 days following vaccination and generally consisting of major alterations in consciousness, unresponsiveness, generalized or focal seizures that persist
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