A Phase 1, Randomized, Double-Blind, Third-Party-Unblinded Trial to Evaluate the Safety and Immunogenicity of 20-valent Pneumococcal Conjugate Vaccine (20vPnC) and 13-valent Pneumococcal Conjugate Vaccine (13vPnC) in Pneumococcal Vaccine-Naïve Adults 50 Years of Age and Older in China
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 400
- 试验地点
- 3
- 主要终点
- Percentage of participants reporting prompted systemic events within 7 days following investigational product administration
研究概览
简要总结
This Phase 1, randomized, double-blind, third-party-unblinded study will be conducted at investigational sites in China. The purpose of the study is to learn about the safety and immune response of 20vPnC and 13vPnC in Chinese adults 50 years of age and older who did not receive any of pneumococcal vaccine in the past
详细描述
The purpose of the study is to learn about the safety and immune response of 20vPnC and 13vPnC vaccines in Chinese adults. This study is seeking for participants who:
- are 50 years of age and older
- did not receive any of vaccines used to treat infections caused by the bacteria called Streptococcus pneumonia in the past.
The participants will be grouped by three age groups:
- Adults between 50 to 59 years of age
- Adults between 60 to 64 years of age
- Adults who are 65 years of age or above
All participants in this study will receive a single dose of 20vPnC or 13vPnC at study clinic. The study will look at the experiences of people receiving 20vPnC and 13vPnC. This will help decide if the study vaccine is safe.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •1.Generally healthy adults including those with preexisting stable disease determined to be eligible based on clinical assessment, medical history and clinical judgment.
排除标准
- •History of microbiologically-proven invasive disease caused by Streptococcus pneumoniae
- •Previous vaccination with any licensed or investigational pneumococcal vaccine or planned receipt through study participation.
研究组 & 干预措施
20vPnC
Single dose of 20-valent pneumococcal conjugate vaccine
干预措施: 20vPnC (Biological)
13vPnC
Single dose of 13-valent pneumococcal conjugate vaccine
干预措施: 13vPnC (Biological)
结局指标
主要结局
Percentage of participants reporting prompted systemic events within 7 days following investigational product administration
时间窗: Within 7 days after vaccination
Prespecified systemic events (fever, headache, fatigue, muscle pain, and joint pain)
Percentage of participants reporting serious adverse events (SAEs) throughout the study
时间窗: Within 6 months after vaccination
SAEs occurring within 6 months after vaccination
Percentage of participants reporting adverse events (AEs) through 1 month following investigational product administration
时间窗: Within 1 month after vaccination
Adverse events occurring within 1 month after vaccination
Percentage of participants reporting prompted local reactions within 7 days following investigational product administration
时间窗: Within 7 days after vaccination
Prespecified local reactions (redness, swelling, and pain at the injection site)
Percentage of participants reporting abnormal hematology, biochemistry, and urinalysis and microscopy laboratory values
时间窗: 3 to 5 days after vaccination
Abnormal hematology, biochemistry, and urinalysis and microscopy laboratory values
次要结局
- Pneumococcal serotype-specific Opsonophagocytic activity (OPA) geometric mean titer (GMT)(1 month after vaccination)
- Pneumococcal serotype-specific OPA geometric mean fold rise (GMFR)(Before vaccination to 1 month after vaccination)