An Open, Multicenter Clinical Trial to Investigate the Immunogenicity and Safety of the Pneumococcal 7-Valent Conjugate Vaccine (PREVENAR) in Sickle Cell Disease Infants.

Wyeth is now a wholly owned subsidiary of Pfizer1 个研究点分布在 1 个国家目标入组 51 人开始时间: 2001年5月1日最近更新: 2006年8月24日

适应症

试验速览

阶段: 4 期
状态: 终止
发起方
入组人数: 51
试验地点: 1
主要终点: Antibody responses to pneumococcal capsular polysaccharides antigens contained in PCV7 vaccine; local and systemic reactions.

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The primary objectives of this study were to assess the immunogenicity and the tolerance of the heptavalent pneumococcal conjugate vaccine (Prevenar) in young infants (2 months of age) with sickle cell disease when administred at 2,3, and 4 months of age.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Single Group
主要目的: Prevention
盲法: None

入排标准

年龄范围: 57 Days 至 112 Days（Child）
性别: All
接受健康志愿者: 否

入选标准

•Infants with neonatal diagnosis of sickle cell disease and confirmed hemoglobin status by hemoglobin electrophoresis.

排除标准

•Previous immunization with pneumococcal-containing vaccines.
•History of pneumococcal invasive disease (meningitis, bacteremia, pneumonia).
•Known or suspected impairments of the immune system (including HIV infection) or recipients of immuno-suppressant agents.
•Other Exclusions apply.

结局指标

主要结局

Antibody responses to pneumococcal capsular polysaccharides antigens contained in PCV7 vaccine; local and systemic reactions.

次要结局

Opsonophagocytic activity; S. pneumoniae nasopharyngeal carriage.

研究者

发起方

Wyeth is now a wholly owned subsidiary of Pfizer

申办方类型

Industry

研究点 (1)

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