EUCTR2006-002898-47-ES进行中（未招募）不适用
A phase IIIb open study to assess the safety and immunogenicity of GlaxoSmithKline (GSK) Biologicals´ 10-valent pneumococcal conjugate vaccine when co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine in preterm infants as a 3-dose primary immunisation course during the first 6 months of life - 10PN-PD-DIT-015
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 300
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:
- •?Subjects who 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) should be enrolled in the study.
- •?A male or female between, and including, 8-16 weeks (56-118 days) of age at the time of the first vaccination.
- •?Written informed consent obtained from the parent or guardian of the subject.
- •?Born after a gestation period of >27 weeks (at least 189 days).
- •Subjects of the Preterm I and Preterm II group:
- •?Medically stable* prematurely born infants, born after a gestation period of 27-36 weeks.
- •*Medically stable refers to the condition of premature infants who do not require significant medical support or ongoing management for debilitating disease and who have demonstrated a clinical course of sustained recovery.
- •Subjects of the Full term group:
- •?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: 300
- •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 vaccines within 30 days preceding the first dose of study vaccines, or planned use during the study period (active phase and 5 months extended safety follow-up)
- •?Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs from birth 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 from one month (30 days) before the first dose of vaccines (Visit 1) and up to Visit 6.
- •?Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b, Neisseria meningitidis and/or Streptococcus pneumoniae with the exception of vaccines where the first dose can be given within the first two weeks of life according to the national recommendations (for example hepatitis B vaccination, BGC vaccination)
- •?History of or intercurrent diphtheria, tetanus, pertussis, hepatitis B, polio, Haemophilus influenzae type b disease, Neisseria meningitidis.
- •?History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
- •?History of any neurologic disorders or seizures.
- •?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, mild upper respiratory infection with or without temperature increase, i.e. oral/axillary/tympanic temperature <37.5°C / rectal temperature <38°C )
- •?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.
- •?Major congenital defects or serious chronic illness.
- •?Administration of immunoglobulins, with the exception of monoclonal antibodies against RSV, and/or any blood products within one month (30 days) preceding the first dose of study vaccines or planned administration during the active phase of the study.
研究者
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