A Phase 3, Open Label Trial Evaluating the Safety, Immunogenicity and Impact of 13-valent Pneumococcal Conjugate Vaccine in Alaskan Native Children.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 373
- 试验地点
- 22
- 主要终点
- Percentage of Participants Achieving Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Level ≥0.35 Micrograms Per Milliliter (Mcg/mL) 1 Month After the Infant Series
研究概览
简要总结
This study is to evaluate the safety, immunogenicity and impact of 13-valent Pneumococcal conjugate vaccine in Alaskan Native Children.
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
- 42 Days 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female infants 6 weeks to < 5years of age in good health, available for the entire study period and reachable by phone, parents able to complete all relevant study procedures.
- •Infants who have received Prevnar are eligible to participate, but this is not required.
- •Infants participating in the blood draws must live in a specific identified area (Yukon Kuskokwim Delta region)
排除标准
- •Contraindication to vaccination with pneumococcal vaccine or allergic reaction to any vaccines or vaccine related components, immune deficiency, bleeding disorder or major known congenital malformation.
结局指标
主要结局
Percentage of Participants Achieving Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Level ≥0.35 Micrograms Per Milliliter (Mcg/mL) 1 Month After the Infant Series
时间窗: 28 to 56 days after vaccination 3 for Group 1, after vaccination 2 for Group 2, and after vaccination 1 for Group 3.
Percentage of participants in 13vPnC Groups 1, 2 and 3 achieving predefined antibody threshold ≥0.35 mcg/mL along with the corresponding 95% 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 upon the observed proportion of participants.
Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Toddler Dose
时间窗: 28 to 56 days after vaccination 4 for Group 1, after vaccination 3 for Group 2, and after vaccination 2 for Group 3.
Percentage of participants in 13vPnC Groups 1, 2, and 3 achieving predefined antibody threshold ≥0.35 mcg/mL 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 upon the observed proportion of participants.
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Relevant Catch-Up Dose
时间窗: 28 to 56 days after vaccination 2 for Group 4, and after the single vaccination in Group 5.
Percentage of participants in 13vPnC Groups 4 and 5 achieving predefined antibody threshold ≥0.35 mcg/mL 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 upon the observed proportion of participants.
次要结局
- Percentage of Participants Achieving Serum IgG Antibody Level ≥0.35 Mcg/mL Prior to Vaccination With 13vPnC (Groups 4 and 5 Only)(28 to 56 days before vaccination 2 for Group 4, and before the single vaccination in Group 5.)
- Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Infant Series(28 to 56 days after vaccination 3 for Group 1, after vaccination 2 for Group 2, and after vaccination 1 for Group 3.)
- Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Toddler Dose(28 to 56 days after vaccination 4 for Group 1, after vaccination 3 for Group 2, and after vaccination 2 for Group 3.)
- Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Relevant Catch-up Dose(28 to 56 days after vaccination 2 for Group 4, and after the single vaccination in Group 5.)
- Percentage of Participants Reporting Pre-Specified Local Reactions: Catch-up Dose 1(Day 1 through Day 7 after vaccination 1 for Group 4 and after the single vaccination in Group 5.)
- Percentage of Participants Reporting Pre-Specified Local Reactions: Catch-up Dose 2(Day 1 through Day 7 after vaccination 2 for Group 4)
- Percentage of Participants Reporting Pre-Specified Systemic Events: Catch-up Dose 1(Day 1 through Day 7 after vaccination 1 for Group 4 and after the single vaccination in Group 5.)
- Percentage of Participants Reporting Pre-Specified Systemic Events: Catch-up Dose 2(Day 1 through Day 7 after vaccination 2 for Group 4)