EUCTR2012-005367-27-SK进行中（未招募）不适用
Evaluation of the immunogenicity and safety of a booster dose of Pfizer’s 13-valent pneumococcal conjugate vaccine (PCV) in children primed with 2 doses of either GSK’s 10-valent PCV or Pfizer’s 13-valent PCV in the Slovak Republic. - PCV-MIXED-SCHEDULE
BIOVOMED0 个研究点开始时间: 2013年2月5日最近更新:
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试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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 ALL the following criteria at study entry:
- •Subjects who the investigator believes that their parent(s)/Legally
- •Acceptable Representative(s) (LARs) can and will comply with the
- •requirements of the protocol (e.g. completion of the diary cards, return
- •for follow-up visits).
- •Written informed consent obtained from the parents/LAR(s) of the
- •Healthy subjects as established by medical history and clinical
- •examination before entering into the study.
- •Subjects between and including 11 to 12 months of age at the time of
- •vaccination for booster dose with PCV13.
- •Previously completed two-dose vaccination course till month 6 with
- •either 10Pn-PD-DiT for Group 10Pn-PD-DiT or PCV13 for Group PCV13.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 92
- •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 for all subjects. If ANY exclusion criterion applies, the subject must not be
- •included in the study:
- •Child in care (A child who has been placed under the control or
- •protection of an agency, organisation, institution or entity by the courts,
- •the government or a government body, acting in accordance with powers
- •conferred on them by law or regulation.)
- •Use of any investigational or non-registered product (drug or vaccine)
- •other than the study vaccine within 30 days preceding the 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 = 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 study period starting from 30 days before
- •the dose and ending 30 days after the dose of vaccine(s), with the
- •exception of licensed influenza vaccines and licensed DTP vaccines.
- •The licensed influenza vaccines are always allowed, even if
- •concomitantly administered with the study vaccines.
- •Administration of any of the vaccines mentioned above has to be
- •documented in the Concomitant vaccination of the CRF (Case Record
- •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 booster vaccination against S. pneumoniae.
- •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.
- •History of any reaction or hypersensitivity likely to be exacerbated by
- •any component of the vaccine(s).
- •Major congenital defects or serious chronic illness.
- •History of any neurological disorders or seizures.
- •Acute disease and/or fever at the time of enrolment. Subjects with
- •temperature bellow 37.5°C on oral, axillary or tympanic setting, or
- •bellow 38.0°C on rectal setting and subjects with mild disease without
- •fever e.g mild diarrhea or mild URTI may be enrolled at the discreation
- •of the investigator.
- •Administration of immunoglobulins and/or any blood products within
- •the 3 months preceding vaccination or planned administration during
- •study period.
- •Any medical condition which might interfere with the assessment of
- •the study objectives in the opinion of the investigator.
- •Anaphylaxis following previous administration of a pneumococcal
- •conjugate vaccine.
研究者
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