NCT00276107已完成4 期
An Open-Label Trial of the Immunogenicity and Safety of Prevenar (Pneumococcal 7-Valent Conjugate Vaccine [Diphteria CRM197 Protein Conjugate]) in Healthy Infants at 2, 4 and 6 Months of Age
Wyeth is now a wholly owned subsidiary of Pfizer0 个研究点目标入组 200 人开始时间: 2004年12月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 主要终点
- To determine the immunogenicity of Prevenar in infants immunized at 2, 4 and 6 months of age
研究概览
简要总结
To determine the immunogenicity of Prevenar in infants immunized at 2, 4 and 6 months of age. To determine the antibody responses to the seven pneumococcal vaccine serotypes one month after second dose and determine the safety of Prevenar in infants immunized at 2,4 and 6 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
- 42 Days 至 100 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female children 2 months of age (42 to 100 days) in good health.
- •An informed consent must be signed by a parent or legal guardian following a detailed explanation of participation in the study.
- •Infants whose parent(s)/guardian(s) will be available for the entire study period.
排除标准
- •Hypersensitivity to any component of the vaccine, including diphtheria toxoid
- •Infants with thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection
- •Infants with known or suspected impairment of immunologic functions including HIV or those receiving immunosuppressive therapy.
- •Other exclusions apply.
结局指标
主要结局
To determine the immunogenicity of Prevenar in infants immunized at 2, 4 and 6 months of age
次要结局
- To determine the antibody responses to the seven pneumococcal vaccine serotypes after second dose and to determine the safety of Prevenar in infants immunized at 2, 4 and 6 months of age
研究者
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