REVACCINATION WITH PREVENAR 13 - CHARACTERIZATION OF THE LATE IMMUNE RESPONSE AFTER POLYSACCHARIDE (REPLAY).
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 89
- 试验地点
- 4
- 主要终点
- Percentage of Participants Achieving a Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to ( ≥) 0.35 Micrograms Per Milliliter (mcg/mL) Measured 1 Month After Vaccination
研究概览
简要总结
The primary purpose of this study is to evaluate the immune response to 13-valent pneumococcal conjugate vaccine (13vPnCV) in children who as infants received either a complete series of PnCV versus a combination of PnCV and pneumococcal polysaccharide vaccine (PSV). This study is also intended to evaluate the safety of the 13vPnC.
详细描述
Follow-up measure for the EMEA supporting a Type II variation for Prevenar (PCV7) label
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fully vaccinated children who participated in a previous Wyeth study (Study D139-P506) and received a booster dose of either 23-valent pneumococcal polysaccharide vaccine (PPV23) or pneumococcal conjugate vaccine (PnCV) per the original protocol for that study.
- •Subjects must be in good health as determined by medical history, physical examination and clinical judgment.
排除标准
- •Known allergy to any component of the 7-valent pneumococcal conjugate vaccine (7vPnC) or 13-valent pneumococcal conjugate vaccine (13vPnC).
- •History of documented invasive pneumococcal disease (defined as a positive culture of S. pneumoniae from a normally sterile body site).
- •Any known or suspected disease or dysfunction of the immune system, including: HIV infection, Malignancy, Receipt of immunosuppressive therapy, Sickle cell hemoglobinopathy.
- •Receipt of immune-globulin within the past 3 months.
- •Receipt of either PSV or 7vPnCV since the completion of Study D139-P506.
结局指标
主要结局
Percentage of Participants Achieving a Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to ( ≥) 0.35 Micrograms Per Milliliter (mcg/mL) Measured 1 Month After Vaccination
时间窗: Day 28
Percentage of participants achieving predefined antibody threshold ≥ 0.35 mcg/mL along with the corresponding 95 percent (%) Confidence Interval (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. Exact 2-sided CI based on the observed proportion of participants.
Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥ 1:8 Measured 1 Month After Vaccination
时间窗: Day 28
Percentage of participants achieving OPA 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. Exact 2-sided CI based on the observed proportion of participants.
次要结局
- Antibody Response Measured 1 Month After Vaccination (Avidity Assay)(Day 28)
- Antibody Response Measured 1 Month After Vaccination (OPA)(Day 28)