NCT01892618已完成3 期
A Randomized Phase III Trial to Determine Whether Conjugated Pneumococcal Vaccine Can Improve the Immune Responsiveness Compared to Polyclonal Pneumococcal Vaccine in Patients With Untreated Chronic Lymphocytic Leukemia
Karolinska University Hospital1 个研究点 分布在 1 个国家目标入组 134 人开始时间: 2013年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 134
- 试验地点
- 1
- 主要终点
- Immune response to Pneumovax compared to immune response to Prevenar
研究概览
简要总结
The purpose of the study is to determine whether patients with chronic lymphocytic leukaemia (CLL) will benefit from vaccination with a 13-valent conjugated pneumococcal vaccine, Prevenar13, compared with a conventional 23-valent capsular polysaccharide vaccine in terms of immune response.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Untreated CLL patients all Rai stages (0 to IV), as early as possible after diagnosis, always before any therapy with monoclonal antibodies and/or chemotherapy
排除标准
- •Immunosuppressive therapy planned to start within 1 month
- •Other malignancies
- •Corticosteroids or other immunosuppressive drugs
- •Previous allergic reaction to any vaccination in the past
- •Neutropenia (PMNs < 500 cells/mm3)
研究组 & 干预措施
Pneumovax
Active Comparator
Pneumovax, 1x 0.5 ml injection
干预措施: Pneumovax (Drug)
Prevenar 13
Experimental
Prevenar 13, 1x 0.5 ml injection
干预措施: Prevenar 13 (Drug)
结局指标
主要结局
Immune response to Pneumovax compared to immune response to Prevenar
时间窗: 1 month post vaccination
次要结局
- Serotype-specific immunoglobulin G (IgG) antibody levels(1 and 6 months post vaccination)
- Levels of opsonophagocytic antibodies (OPA)(6 months post vaccination)
- Serotype-specific IgG antibody levels by ELISA, geometric mean concentrations (GMCs)between arms(1 and 6 months post vaccination)
研究者
Eva Kimby
Professor
Karolinska University Hospital
研究点 (1)
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