EUCTR2009-012087-13-DE进行中（未招募）不适用
A Phase 3, Open-label Trial to Evaluate the Safety, Tolerability, and Immunogenicity of 13-valent Pneumococcal Conjugate Vaccine Followed by 23-valent Pneumococcal Polysaccharide Vaccine in Recipients of Allogeneic Hematopoietic Stem Cell Transplant Aged 2 Years and Older
Wyeth Research Division of Wyeth Pharmaceuticals Inc., A Pfizer Company0 个研究点目标入组 300 人开始时间: 2009年10月6日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 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
- •Male or female subject =2 years of age.
- •Allogeneic HSCT for hematologic disorder.
- •Allogeneic HSCT with full myeloablative conditioning or reduced intensity conditioning.
- •Allogeneic HSCT approximately 3 to 6 months (91 days to 203 days) before enrollment.
- •Stable engraftment (absolute neutrophil count (ANC) >1000/µL; platelet count >50,000/µL).
- •Complete hematologic remission of underlying disease with very good partial remission (VGPR) acceptable in the case of lymphoma and myeloma.
- •Subject or parent/legal guardian expected to be available for the entire study and can be contacted by telephone.
- •Subject or parent/legal guardian must be able to complete an electronic diary (e-diary) and complete all relevant study procedures during study participation.
- •Hematological recovery as defined by ANC >1000/µL; platelet count >50,000/µL.
- •All female and male subjects who are biologically capable of having children must agree to abstinence or commit to the use of a reliable method of birth control from signing of the ICF until 3 months after the last vaccination.
- •Negative urine pregnancy test for all female subjects of child bearing potential.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 150
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 75
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 75
排除标准
- •Autologous HSCT.
- •Receipt of donor lymphocyte infusions during the 28 days preceding enrollment.
- •Uncontrolled GVHD that in the opinion of the investigator would prevent the subject from participating in the study.
- •Lansky/Karnofsky Score =60%.
- •Receipt of plasma products or immunoglobulins during the 60 days preceding enrollment.
- •Receipt of rituximab since HSCT.
- •Receipt of chemotherapy for relapse of underlying malignant disease since HSCT.
- •Human immunodeficiency virus (HIV) infection.
- •Lymphoproliferative disorder since HSCT.
- •Chronic illnesses with cardiac, pulmonary, renal, or liver failure that in the opinion of the investigator would prevent the subject participating in the study.
- •Vaccination with any licensed or experimental pneumococcal vaccine since HSCT.
- •Previous anaphylactic reaction to any vaccine or vaccine-related component.
- •Bleeding diathesis or condition associated with prolonged bleeding time that would in the opinion of the investigator contraindicate intramuscular injection.
- •Participation in another study with ongoing use of an unlicensed investigational product from 28 days before study enrollment until the end of the study.
- •Participation in another study with ongoing use of a licensed investigational product that in the opinion of the
- •investigator would interfere with the evaluation of the study objectives.
- •Permanent residence in a nursing home or other residential care facility.
- •Pregnant or breastfeeding female subject.
- •Subject who is a direct relative (child, grandchild, parent, or grandparent) of study personnel, or is a member of the study personnel.
- •Receipt of advanced therapy medicinal products (ATMP) including gene therapy products, somatic cell therapy products, and tissue engineered products at any time before enrollment.
- •If information is available, previous allergic or anaphylactic reaction to any vaccine or vaccine-related component in a stem cell donor.
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