A Phase 3, Open-Label Trial, Evaluating the Safety, Tolerability, and Immunogenicity of 13-valent Pneumococcal Conjugate Vaccine in Healthy Children Previously Partially Immunized With Prevenar
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 234
- 试验地点
- 8
- 主要终点
- Geometric Mean Concentration (GMC) of Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibodies 1 Month After the Toddler Dose
研究概览
简要总结
The purposes of this study are to evaluate the safety of 13-valent pneumococcal Conjugate Vaccine (13vPnC) in children who have already been vaccinated with Prevenar. The study will also assess the immunological response (measure the amount of antibodies, i.e. proteins that fight off germs) produced by children after they have been given the 13-valent pneumococcal vaccine at 5 and 12 months or 12 months of age. In addition, reactions at the injection site will be assessed during the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 140 Days 至 392 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy children previously immunized with 1 or 2 doses of Prevenar.
- •Group 1: Male or female subjects between the age of >=140 and <=196 days of age at time of enrollment.
- •Group 2: Male or female subjects between the age of >=336 and <=392 days of age at time of enrollment
- •Available for entire study period.
排除标准
- •Previous reaction or contra-indication to pneumococcal vaccine or vaccine related component.
- •Previous vaccination with licensed or investigational pneumococcal vaccine other than Prevenar.
结局指标
主要结局
Geometric Mean Concentration (GMC) of Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibodies 1 Month After the Toddler Dose
时间窗: 1 month after the toddler dose (13 months of age)
Antibody geometric mean concentration (GMC) as measured by micrograms per milliliter (mcg/mL) for 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) were presented. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. GMCs were calculated using all participants with available data for the specified blood draw.
次要结局
- Percentage of Participants Achieving a Serotype-specific IgG Antibody Greater Than or Equal To (≥) 0.35 Mcg/mL, 1 Month After the Infant Dose(1 Month after the infant series (6 months of age))
- GMC of Serotype-Specific Pneumococcal IgG Antibodies Measured 1 Month After the Infant Dose(1 Month after the infant series (6 months of age))
- GMC of Serotype-Specific Pneumococcal IgG Antibodies Measured Before the Toddler Dose(12 months of age (prior to toddler dose))