A phase III, open, controlled, multi-centric study to evaluate the immunogenicity, safety and reactogenicity of GSK Biologicals' 10-valent pneumococcal conjugate vaccine when administered to children aged between 2 to17 years who are at an increased risk of pneumococcal infection and to an age-matched control group of healthy children aged 24 to 59 months. - 10PN-PD-DIT-072

GlaxoSmithKline Biologicals0 个研究点目标入组 100 人开始时间: 2013年1月11日最近更新: 2013年1月14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: 100

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 (e.g. completion of the diary cards).
•Written informed consent obtained from the parent(s)/LAR(s) of the subject and informed assent obtained from the subject, if appropriate, prior to enrolment.
•Female subjects of non-childbearing potential may be enrolled in the study. (Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy or ovariectomy).
•Please refer to the GLOSSARY OF TERMS for the definition of menarche.
•Female subjects of childbearing potential may be enrolled in the study, if the subject:
•-has practiced adequate contraception for 30 days prior to vaccination, and
•-has a negative pregnancy test on the day of vaccination, and
•-has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.
•Priming status:
•- Children who have not been previously vaccinated with any pneumococcal vaccine, i.e. either plain polysaccharide pneumococcal vaccine, Synflorix (10Pn-PD-DiT), Prevenar or Prevenar13 will be considered for inclusion in the unprimed groups.
•- Children who have been previously vaccinated with:
•* at least one dose of a pneumococcal conjugate vaccine, i.e. either Synflorix (10Pn-PD-DiT), Prevenar or Prevenar13
•* with plain polysaccharide pneumococcal vaccine more than 2 years and less than 5 years before enrolment.
•will be considered for inclusion in the primed groups.
•Additional inclusion criteria for the At-risk groups:
•A male or female aged between, and including, 2 and 17 years at the time of first vaccination.
•For the purpose of this study, at-risk subject is a subject with:
•-Congenital or acquired asplenia such as anatomic, surgical or functional asplenia or
•-Splenic dysfunction, chronic gastrointestinal disorders, liver disease, infiltrative disorders, vascular disorder etc or
•Note: All individuals who are diagnosed by the investigator as with splenic dysfunction are eligible for enrolment in the At-risk group. When available, investigator will collect medical documentation for reduced splenic function diagnosed with an appropriate technique (e.g. scintiscan, pitted erythrocyte counting or Howell-Jolly body detection) in the At-risk subject’s medical records. No further assessment will be necessary. A maximum of 35 individuals with sickle-cell disease can be enrolled in the At-risk group. These subjects do not require assessment of the splenic function as sickle-cell disease is invariably associated with severe splenic dysfunction [Pearson, 1969].
•-Complement deficiencies, e.g.C1-C4, C5-C9, properdin factor H or factor D.
•For all subjects defined as At-risk the Investigator will make all efforts to collect information from the subject/subject’s parent(s)/LAR(s) during the interview and/or from previously available medical documentation on the date and conditions which have made a child at-risk of pneumococcal infection and/or the results of tests determining spleen dysfunction or complement deficiency. This should be documented in the medical records of the At-risk subject. No originals/copies of medical documentation are needed.
•Additional inclusion criteria for the Healthy group:
•A male or female matched (for age and country) to a subject aged 24-59 months from the At-risk group.
•Healthy subjects as established by m

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.
•Planned administration/administration of a vaccine not foreseen by the study protocol during the period starting 30 days before each dose of vaccine(s) and ending 30 days after*
•* In case an emergency mass vaccination for an unforeseen public health threat (e.g.: a pandemic) is organised by the public health authorities, outside the routine immunization program, vaccines can be administered at any time during the study period provided it is licensed and used according to its Summary of Product Characteristics or Prescribing Information and according to the local governmental recommendations and that a written approval of the Sponsor is provided. Vaccines that are recommended for subjects with an increased risk of bacterial infection (for example meningococcal, Hib vaccines, etc, except a pneumococcal vaccine), can be administered at any time to the subjects enrolled in the At-risk group.
•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).
•History of any neurological disorders or seizures.
•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 axillary.
•-Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator.
•History of chronic alcohol consumption and/or drug abuse.
•Any confirmed or suspected Human Immunodeficiency virus (HIV) infection, based on medical history and physical examination (no laboratory testing required).
•History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
•Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
•Pregnant or lactating female.
•Female planning to become pregnant or planning to discontinue contraceptive precautions.
•Major congenital defects except medical conditions that define an At-risk subject (see section 1.3).
•Previous vaccination against pneumococcal infection with pneumococcal conjugate vaccine within the last 8 weeks.
•Previous vaccination against pneumococcal infection with plain polysaccharide (e.g. Pneumovax) vaccine within the last 2 years.
•Additional exclusion criteria for the Healthy group:
•Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. (For corticosteroids, this will mean prednisone ? 0.5 mg/kg/day with an upper limit of 20 mg/day, or equivalent). Inhaled and topical steroids are allowed.
•Serious chronic illness.
•Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
•Family history of congenital or hereditary immunodeficiency.

研究者

发起方

GlaxoSmithKline Biologicals

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