A Phase 4, Open-label Study to Evaluate Persistence of the Antibody Response Elicited by Prevenar in Healthy Children in China Who Have Been Previously Immunized With a 4-dose Series of a Pneumococcal Conjugate Vaccine During Infancy in Study 0887x-101518
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 335
- 试验地点
- 10
- 主要终点
- Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 36 Months After the Toddler Dose
研究概览
简要总结
In 2005, Wyeth conducted study 0887X-101518 (NCT00488826) in which Chinese infants received either Prevenar alone (Group 1), Prevenar given with a Diphtheria, Tetanus and acellular Pertussis (DTaP) vaccine (Group 2) or DTaP alone (Group 3). This follow up study (at least 3 years after the last vaccination) will assess the antibody concentrations in children who previously completed Wyeth study 0887X-101518.
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
- 4 Years 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female subjects who participated in and completed Wyeth study 0887X
- •Healthy subject as determined by medical history, physical examination, and judgment of the investigator.
排除标准
- •Vaccination with any licensed or investigational pneumococcal vaccine since completion of Wyeth study 0887X
- •History of culture proven invasive disease caused by S pneumoniae since the completion of Wyeth study 0887X
- •Known or suspected immune deficiency or suppression since participation in Wyeth study 0887X 101518.
研究组 & 干预措施
All subjects
干预措施: Blood draw (Procedure)
结局指标
主要结局
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 36 Months After the Toddler Dose
时间窗: Day 1 (36 months after toddler dose)
Antibody geometric mean concentration (GMC) as measured by mcg/mL for 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F). GMC (7vPnC, 7vPnC/DTaP, and DTap) 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.
次要结局
未报告次要终点