A Phase 4, Open-label Trial to Assess the Safety, Tolerability and Immunogenicity of Prevenar in Older Infants and Young Children in China Who Are Naive to Previous Pneumococcal Vaccination.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 505
- 试验地点
- 5
- 主要终点
- Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar
研究概览
简要总结
A vaccine called Prevenar is already approved for use in China for vaccination of children younger than 6 years old against infections caused by Streptococcus pneumoniae.
This study is to measure the amount of antibodies (antibodies help people fight off diseases) Chinese children aged between 121 days and 6 years (72 months) produce when given Prevenar. The study will also provide more data on how safe and well tolerated Prevenar is in Chinese children.
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
- 121 Days 至 72 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Chinese male or female subjects.
- •Between 121 days to less than 72 months of age at the time of entry into the study.
排除标准
- •Receipt of previous vaccine against Pneumo
- •Previous anaphylactic reaction to any vaccine or part of a vaccine
- •Previous proven invasive Pneumo infection
- •Receipt of investigational drug or device within the proceeding 28 days
结局指标
主要结局
Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar
时间窗: 1 month after last dose in each group
Serotype-specific Pneumococcal Immunoglobulin G (IgG) antibody geometric mean concentration (GMC) after 1 month of last dose for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) are presented. GMC and corresponding 2-sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.
Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at Baseline in Each Group
时间窗: Baseline
Serotype-specific Pneumococcal IgG antibody GMC at baseline for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) are presented. GMC and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for the specified blood draw.
次要结局
- Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values in Group 1.(Pre-vaccination to 1 month after third dose of Prevenar in Group 1)
- GMFR of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values at 12 Months After the Last Dose.(Pre-vaccination to 12 months after the last dose)
- Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at 1 Month After the First Dose in Group 3(1 month after first dose of Prevenar in Group 3)
- Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at 1 Month After the Second Dose in Group 2(1 month after second dose of Prevenar in Group 2)
- GMFR of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values in Group 3.(Pre-vaccination to 1 month after first dose of Prevenar in Group 3)
- Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at 1 Month After the Third Dose in Group 1(1 month after third dose of Prevenar in Group 1)
- GMFR of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values in Group 2.(Pre-vaccination to 1 month after second dose of Prevenar in Group 2)
- Antibody Concentrations Against the 7 Pneumococcal Serotypes Contained in Prevenar at 12 Months After the Last Dose.(12 months after the last dose)