A PHASE 3, RANDOMIZED, DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE (20VPNC) IN HEALTHY CHINESE INFANTS
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Pfizer
- 入组人数
- 1,250
- 试验地点
- 4
- 主要终点
- Percentage of participants reporting prespecified local reactions
研究概览
简要总结
The purpose of this study is to evaluate a study vaccine called 20-valent pneumococcal conjugate vaccine (20vPnC). The study will assess whether the study vaccine is safe to use in healthy infants. It will also evaluate if the study vaccine can help the body make antibodies (known as immune response). These antibodies help protect against 20 types of pneumococcal bacteria. The study will compare 20vPnC with 13vPnC (control vaccine), which is approved for use in infants.
The study is seeking participants who:
- Are healthy infants
- Aged 42 to 98 days of age at the time of consent.
Infants will receive either 20vPnC or 13vPnC. Doses will be given at approximately 2, 4, and 6 months of age (Doses 1 through 3). A fourth dose will be given at 12 to 15 months of age. Infants will receive the same vaccine (20vPnC or 13vPnC) for all 4 doses.
The total time of the study will be about 16 to 19 months. A subset of infants will be asked to stay in the study for longer.
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
- Triple (Participant, Care Provider, Investigator)
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 male or female infants born at ≥37 weeks of gestation and who are approximately 2 months of age (≥42 to ≤98 days) at the time of consent (the day of birth is considered Day 1 of life) will be enrolled.
排除标准
- •history of a severe adverse reaction associated with a vaccine and/or severe allergic reactions to any component of the study intervention.
- •significant neurological disorder or history of seizure or significant stable or evolving disorders.
- •major known congenital malformation or serious chronic disorder.
- •history of microbiologically proven invasive disease caused by S. pneumoniae.
- •known or suspected immunodeficiency or other conditions associated with immunosuppression.
- •previous vaccination with any licensed or investigational pneumococcal vaccine or planned receipt through study participation.
研究组 & 干预措施
20vPnC group
Participants receive 20vPnC at approximately 2, 4, and 6 months of age (Doses 1 through 3) and 12 through 15 months of age (Dose 4)
干预措施: 20vPnC (Biological)
13vPnC group
Participants receive 13vPnC at approximately 2, 4, and 6 months of age (Doses 1 through 3) and 12 through 15 months of age (Dose 4)
干预措施: 13vPnC (Biological)
结局指标
主要结局
Percentage of participants reporting prespecified local reactions
时间窗: From Day 1 (the day of vaccination) through Day 7 following Vaccinations 1, 2, 3, and 4
Percentage of participants reporting prespecified systemic events
时间窗: From Day 1 (the day of vaccination) through Day 7 following Vaccinations 1, 2, 3, and 4
Percentage of participants reporting Adverse Events (AEs) from the first study vaccination through 1 month following the third study vaccination.
时间窗: From the first study vaccination to 1 month after the third study vaccination
Percentage of participants reporting AEs from the fourth study vaccination to 1 month following the fourth study vaccination.
时间窗: From the fourth study vaccination to 1 month after the fourth study vaccination
Percentage of participants reporting serious adverse events (SAEs) through 6 months post last vaccination
时间窗: From the first study vaccination to 6 months after the last study vaccination
The percentages of participants with predefined serotype-specific immunoglobulin G (IgG) concentrations in 20vPnC group compared to 13vPnC group at 1 month after Dose 3
时间窗: At 1 month after Dose 3
The serotype-specific IgG geometric mean concentrations (GMCs) in 20vPnC group compared to 13vPnC group at 1 month after Dose 3
时间窗: At 1 month after Dose 3
次要结局
- The percentages of participants with predefined serotype-specific immunoglobulin G (IgG) concentrations in 20vPnC group compared to 13vPnC group at 1 month after Dose 4(At 1 month after Dose 4)
- The serotype-specific IgG geometric mean concentrations (GMCs) in 20vPnC group compared to 13vPnC group at 1 month after Dose 4(At 1 month after Dose 4)
- To further describe the immune response of 20vPnC(At prior to Dose 1, 1 months after Dose 3, prior to Dose 4 and 1 month after Dose 4)