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
- 21
- 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.
研究组 & 干预措施
Group 4
Subjects ≥12 months to <2 years of age.
干预措施: 13-valent Pneumococcal Conjugate Vaccine (Biological)
Group 5
Subjects ≥2 years to <5 years of age
干预措施: 13-valent Pneumococcal Conjugate Vaccine (Biological)
Group 3
Subjects <12 months of age with 2 prior doses of Prevnar.
干预措施: 13-valent Pneumococcal Conjugate Vaccine (Biological)
Group 2
Subjects <12 months of age with 1 prior dose of Prevnar.
干预措施: 13-valent Pneumococcal Conjugate Vaccine (Biological)
Group1
Subjects 6 weeks to <10 months of age with 0 prior dose of Prevnar.
干预措施: 13-valent Pneumococcal Conjugate Vaccine (Biological)
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)