Safety, Tolerability and Immunogenicity of Pneumovax 23 (V110) in Healthy Adults in India
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 133
- 主要终点
- Percentage of subjects exhibiting a >= 2 fold increase in IGG antibody level from pre-vaccination to post-vaccination for both serotypes 1 and 6b
研究概览
简要总结
To describe the safety, tolerability and immunogenicity of pneumovax 23 (V110) in healthy adults in India.
详细描述
This was an open-label non-randomized study to assess the safety and immunogenicity of PNEUMOVAXTM 23 in healthy adults in India. The participants enrolled in this study were healthy Indian adults, 50 years of age or older, with no prior history of having received a pneumococcal vaccination (14-valent or 23-valent) and no prior history of Pneumococcal disease. All participants enrolled in the study received one 0.5 mL dose of PNEUMOVAXTM 23 by intramuscular (deltoid) injection on Day 1. Serum samples were obtained prior to vaccination on Day 1 and on Day 28 (+/-7 days) postvaccination. The duration of participation for each participant was approximately one month, with the study completion at the Day 28 postvaccination bleed and return of the Vaccination Report Card (VRC). Enrollment was completed within approximately 2 months. The last postvaccination blood sample was collected within 3 months of study initiation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy indian adults of 50 years of age
- •In good health; any underlying chronic illness must be documented to be in stable condition
- •Signed and dated informed consent prior to receipt of the study vaccine
排除标准
- •Functional or anatomic asplenia
- •History of auto immune disease
- •Hypersensitivity to any of the components of the study vaccine,including phenol
- •Known or suspected immune dysfunction, including persons with congenital immunodeficiency
- •Prior vaccination with any pneumococcal vaccine
结局指标
主要结局
Percentage of subjects exhibiting a >= 2 fold increase in IGG antibody level from pre-vaccination to post-vaccination for both serotypes 1 and 6b
时间窗: post-vaccination
次要结局
- Any AE within 15 days after vaccination, with particular attention to injection site AE and fever(15 days after vaccination)