A Phase 3, Randomized, Active-Controlled, Double-blind Trial Evaluating the Safety, Tolerability and Immunologic Noninferiority of a 13-valent Pneumococcal Conjugate Vaccine Compared to a 7-valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With Routine Pediatric Vaccinations in the United States
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 666
- 试验地点
- 37
- 主要终点
- Percentage of Participants Reporting Pre-specified Systemic Events
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of the 13-valent pneumococcal vaccine (13vPnC) compare to the 7-valent pneumococcal vaccine (7vPnC) and to compare the immune response to concomitant vaccines administered with 13vPnC and 7vPnC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double
入排标准
- 年龄范围
- 42 Days 至 98 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy 2-month-old infants.
- •Available for the entire study period.
- •Exclusion criteria:
- •Previous vaccination with any vaccine before the start of the study.
- •Known contraindication to vaccination.
排除标准
- 未提供
研究组 & 干预措施
13vPnC vaccine
干预措施: 13 valent pneumococcal conjugate vaccine (Biological)
7vPnC vaccine
干预措施: 7vPnc pneumococcal conjugate vaccine (Biological)
结局指标
主要结局
Percentage of Participants Reporting Pre-specified Systemic Events
时间窗: Within 7 days after each dose
Systemic events (any fever \[Fv\] ≥ 38 degrees Celsius \[C\], decreased (decr.) appetite, irritability, increased (incr.) sleep, decreased sleep, and hives \[urticaria\], use of antipyretic medication \[med\] to treat or prevent symptoms \[sx\]) were reported using an electronic diary. Participants may be represented in more than 1 category.
Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
时间窗: One month after the 3-dose infant series (7 months of age)
Percentages of Participants achieving World Health Organization (WHO) predefined antibody threshold ≥0.35 μg/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.
Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, and Pertussis Antigens in 13vPnC Group Relative to 7vPnC Group After the Infant Series
时间窗: One Month After the Infant Series (7 months of age)
Predefined Antibody Levels for Haemophilus Influenzae Type b (\[Hib\] 0.15 µg/mL or 1.0 µg/mL), Diphtheria Toxoid (0.1 International Units \[IU\]/mL), and Pertussis antigens (Pertussis filamentous hemagglutinin \[FHA\] 40.5 Elisa Units \[EU\]/mL, Pertussis toxoid \[PT\] 16.5 EU/mL, Pertussis pertactin \[PRN\] 26 EU/mL).
Percentage of Participants Reporting Pre-specified Local Reactions
时间窗: Within 7 days after each dose
Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (\[Sig.\], present and interfered with limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters \[cm\] to 2.0 cm); Moderate (\[Mod.\], 2.5 to 7.0 cm); Severe (\[Sev.\], \> 7.0 cm). Participants may have been represented in more than 1 category.
Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose
时间窗: 1 Month After the Toddler Dose
Antibody concentration/geometric mean concentration as measured by enzyme-linked immunosorbent assay (ELISA) 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) are presented.
次要结局
- Percentage of Participants Achieving Functional Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group the 3-Dose Infant Series and the Toddler Dose(One month after infant series and one month after toddler dose)
- Geometric Mean Antibody Concentration of Hib PRP in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose(one month after the toddler dose)
- Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Vaccine Antigens Induced by Measles, Mumps, Rubella, Varicella (MMR-V) and Haemophilus Influenzae Type b (Hib)(One month after toddler dose (13 to 16 months of age))
- Geometric Mean Antibody Concentration of Measles, Mumps, and Varicella ELISA in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose(one month after the toddler dose)
- Geometric Mean Antibody Concentration of Rubella in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose(one month after the toddler dose)
- Geometric Mean Titer (GMT) as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series and the Toddler Dose(one month after the infant series and the toddler dose)