A phase III, open, controlled study to evaluate the immunogenicity, safety and reactogenicity of GSK Biologicals’ 10- valent pneumococcal conjugate vaccine administered to children with sickle cell disease between 8 weeks and 2 years of age, as compared to healthy children. - 10PN-PD-DIT-064

GlaxoSmithKline Biologicals0 个研究点目标入组 300 人开始时间: 2012年4月12日最近更新: 2015年3月23日

适应症

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方: GlaxoSmithKline Biologicals
入组人数: 300

研究概览入排标准研究者记录与标识符相似试验

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

•Subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) [LAR(s)] can and will comply with the requirements of the protocol
•A male or female between, and including: 8 and 11 weeks of age at the time of the first vaccination for subjects in the <6S and <6NS groups or 7 and 11 months at the time of the first vaccination for subjects in the 7-11S and 7-11NS groups or 12 and 23 months at the time of first vaccination for subjects in the 12-23S and 12-23NS groups (Note the second dose should be administered at 23 Months of age at the latest to allow, if needed, compliance with the National Recommendations on administration of the 23-valent polysaccharide pneumococcal vaccine in children with SCD as of 24 months of age).
•Written informed consent, signed or thumb printed, obtained from the parent(s)/LAR(s) of the subject. Where parent(s)/LAR(s) are illiterate, the consent form will be countersigned by a witness.
•Additional inclusion criteria for children with SCD (<6S, 7-11S and 12-23S groups):
•Children with neonatal diagnosis of sickle cell disease [homozygous sickle cell disease (hemoglobin SS disease), double heterozygous sickle hemoglobin C disease (hemoglobin SC disease) and the sickle ß-thalassemias] and confirmed haemoglobin status by haemoglobin chromatography and electrophoresis(<6S group) or electrophoresis (7-11S and 12-23S groups).
•Free of any other known or suspected health problems (as established by medical history and clinical examination before entering into the study), that would contraindicate the initiation of routine immunizations outside a clinical trial context
•Additional inclusion criteria for healthy children (<6NS, 7-11NS and
•12-23NS groups):
•Healthy subjects as established by medical history and clinical examination before entering into the study.
•Children with negative neonatal diagnosis of sickle cell disease and confirmed hemoglobin status by hemoglobin chromatography and/or electrophoresis.
•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

•Child in care
•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 in total) of immunosuppressants or other immune-modifying drugs since birth. For corticosteroids, this will mean prednisone equal or more than 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.
•Planned administration/administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of study vaccines and ending 30 days after. Locally recommended vaccines (recommended through the EPI program or through national immunization campaigns) for example inactivated influenza vaccine are always allowed with the exception of DTP-HBV/Hib in the <6S group and <6NS group, even if concomitantly administered with the study vaccines, but should be documented in the eCRF.
•Subjects being heterozygous or carriers of abnormal haemoglobin (e.g. haemoglobin S, Haemoglobin C) who are not considered to have SCD.
•Additional exclusion criteria for children of the <6S and <6NS group:
•Previous vaccination against diphtheria, tetanus, pertussis, hepatitis B and Haemophilus influenzae type b.
•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).
•Previous vaccination or planned vaccination during the study with any pneumococcal vaccine.
•History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s).
•Major congenital malformations.
•History of any neurological disorders or seizures.
•Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
•Birth weight below 1500g.
•Serious chronic illness other than SCD.
•Acute disease and/or fever at the time of enrolment:
•Fever is defined as temperature = 37.5°C on oral, axillary or tympanic setting, or = 38.0°C on rectal setting. The preferred route for recording temperature in this study will be tympanic. Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator.
•Additional exclusion criteria for children with SCD (<6S, 7-11S and 12-23S groups):
•Any confirmed or suspected immunosuppressive or immunodeficient condition, (including human immunodeficiency virus (HIV) infection) other than SCD related conditions, based on medical history and physical examination (no laboratory testing required).
•Additional exclusion criteria for healthy children (<6 NS, 7-11NS and
•12-23NS groups):
•Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection, based on medical history and physical examination (no laboratory testing required).

研究者

发起方

GlaxoSmithKline Biologicals

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