NCT00574795已完成3 期
A Phase 3, Open-Label Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants in Japan
Wyeth is now a wholly owned subsidiary of Pfizer24 个研究点 分布在 1 个国家目标入组 193 人开始时间: 2007年9月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 193
- 试验地点
- 24
- 主要终点
- Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the 3-Dose Infant Series
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of the 13-valent pneumococcal conjugate vaccine (13vPnC) in infants of Japanese descent.
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
- 2 Months 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy 2 to 6 month-old infant
- •Available for entire study period
排除标准
- •Previous vaccination with licensed or investigational pneumococcal vaccine.
- •Previous anaphylactic reaction to any vaccine or vaccine-related component.
- •Contraindication to vaccination with a pneumococcal conjugate vaccine.
- •Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate any type of injection.
- •Known or suspected immune deficiency or suppression.
结局指标
主要结局
Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the 3-Dose Infant Series
时间窗: one month after 3-dose infant series (at 7 months of age)
Percentages of participants achieving World Health Organization (WHO) predefined antibody threshold ≥ 0.35 μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
次要结局
- Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the 3-Dose Infant Series(one mone month after 3-dose infant series (at 7 months of age))
- Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the Toddler Dose(one month after the toddler dose (at 12 - 15 months of age))
- Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the Toddler Dose(one month after the toddler dose (at 12-15 months of age))
研究者
研究点 (24)
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