EUCTR2018-003068-29-FR进行中（未招募）1 期
Evaluation of immunological response following a revaccination with PPS23 boosted or not by PCV13 in splenectomised patients (SPLENEVAC-2) - SPLENEVAC-2
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 56
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
- •1.Age = 18 years and = 75 years.
- •2.Splenectomised patients.
- •3.For patients not enrolled in SPLENEVAC clinical trial: presence of Jolly Body at blood smear and confirmation by abdominal ultrasound.
- •4.Vaccinated according to the schedule of SPLENEVAC clinical trial (PCV13 / PPS23 two months later), enrolled or not from this study. Vaccination of PPS23 must have been administered 5 years +/- 6 months before inclusion.
- •5.Patients will be followed during the 24 months from the inclusion visit.
- •6.Patients must give written informed consent prior to any trial procedure.
- •7.Women of childbearing age must have an effective contraception during the first 13 months of the study.
- •8.Patients must be covered by social security regimen or equivalent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 45
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 11
排除标准
- •1.History of pneumococcal revaccination in the last five years.
- •2.Having received any another vaccines within 4 weeks prior to enrolment or who is planning to receive any vaccine (for example: ZOSTAVAX®) within the first 13 months of the study (excepted seasonal influenza vaccine which is permitted 4 weeks before and after each vaccination visit of the study and then allowed at any time during the study follow up).
- •3.History of known allergies to any component of both study vaccines.
- •4.History of anaphylactic reaction following vaccination.
- •5.Infusion of immunoglobulins within the three months preceding the inclusion.
- •6.Any pathology or condition that may impair the immune response, apart from splenectomy: immunosuppressive therapy in progress or in the 6 months prior to inclusion, hematopoietic stem cells allo / autograft, primary immunodeficiency, nephrotic syndrome, sickle cell disease, progressive neoplasia, evolutive cancer, cirrhosis, known infection to HIV and / or HBV (HBs Ag +) and / or HCV, taking corticosteroids > 10mg for more than 7 days within the month preceding the inclusion or planning to take any during the study, inhaled corticosteroid cutaneous topical being allowed.
- •7.Coagulation disorder contra-indicating intramuscularly injections.
- •8.Acute respiratory tract infection or severe acute febrile illness or systemic reaction which could represent a significant risk in case of vaccination within the month before inclusion.
- •9.Pregnancy, breastfeeding or positive pregnancy test up to 13 months after inclusion.
- •10.History of suspected or documented invasive pneumococcal infection within the year before inclusion.
- •11.No immunosuppressive factors associated.
- •12.Enrolment in any other clinical trial during the whole trial period except observational study.
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