A PHASE 1, OPEN-LABEL STUDY TO EVALUATE THE SAFETY AND TOLERABILITY OF A 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY CHINESE ADULTS, CHILDREN, AND INFANTS
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Pfizer
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Percentage of participants reporting prespecified local reactions within 7 days following each study intervention
研究概览
简要总结
The purpose of this study is to learn about the safety of the 20-valent pneumococcal conjugate vaccine (20vPnC) among adults, children, and infants, as well as the immunogenicity of 20vPnC among infants and children under 2 years of age in China. This vaccine will be given as per the age-specific dosing schedules among healthy adults, children and infants in China.
This study is seeking healthy participants of 6 groups:
- Group 1: Adults ≥18 to <50 years of age
- Group 2: Children ≥2 to <6 years of age
- Group 3: Children ≥12 months to <2 years of age
- Group 4: Infants ≥7 to <12 months of age
- Group 5: Infants ≥42 to ≤98 days of age
- Group 6: Infants ≥42 to ≤98 days of age
All participants in Group 1 to 5, in this study will receive 20vPnC as per the age-specific dosing schedules:
- Group 1: participants will receive 1 dose of 20vPnC.
- Group 2: participants will receive 1 dose of 20vPnC.
- Group 3: participants will receive 2 doses of 20vPnC. Dose 2 will be given 56 to 70 days after Dose 1.
- Group 4: participants will receive 3 doses of 20vPnC. Dose 2 will be given 28 to 56 days after Dose 1, and Dose 3 will be given at 365 to <455 days of age and at least 56 days after Dose 2.
- Group 5: participants will receive 4 doses of 20vPnC. Dose 2 will be given 42 to 63 days after Dose 1, and Dose 3 should be given 42 to 63 days after Dose 2, and Dose 4 should be given at 365 to <455 days of age.
Participants in Group 6 will be randomized in a 1:1 ratio to received either 20vPnC or 13vPnC:
- Group 6: participants will receive 4 doses of 20vPnC or 13vPnC. Dose 2 will be given 42 to 63 days after Dose 1, and Dose 3 should be given 42 to 63 days after Dose 2, and Dose 4 should be given at 365 to <455 days of age.
The study will look at the experiences of people receiving the study vaccine. The study will also look at the immune response of some people receiving the study vaccine. This will help decide if the study vaccine is safe.
The total duration of taking part in the study from each group is:
- Participants in Group 1 and Group 2 will take part for about 6 months, with 6 visits.
- Participants in Group 3 will take part for about 8 months, with 9 visits.
- Participants in Group 4 will take part for about 12 months, with 8 visits.
- Participants in Group 5 and 6 will take part for about 16 to 19 months, with 11 visits.
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
- None
盲法说明
This is an open label study. Participant, investigators, and sponsor will be unblinded to the participant's assigned study intervention.
入排标准
- 年龄范围
- 42 Days 至 49 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female participants:
- •Adults ≥18 to <50 years of age
- •Children ≥2 to <6 years of age
- •Children ≥12 months to <2 years of age
- •Infants ≥7 to <12 months of age
- •Infants ≥42 to ≤98 days of age
- •Healthy participants determined by clinical assessment and clinical judgment, to be eligible for the study.
排除标准
- •History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention, or any diphtheria toxoid-containing vaccine.
- •History of microbiologically proven invasive disease caused by S pneumoniae.
- •Congenital, functional, or surgical asplenia.
- •Previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt during study participation.
- •Determined as not eligible by the investigator based on the participant's past and present health condition(s), medication(s) and treatment(s).
- •Please refer to the study contact for further eligibility details.
研究组 & 干预措施
Cohort 1
Participants will receive 1 dose of 20vPnC Vaccine.
干预措施: 20vPnC (Biological)
Cohort 2
Participants will receive 1 dose of 20vPnC Vaccine.
干预措施: 20vPnC (Biological)
Cohort 3
Participants will receive 2 doses of 20vPnC Vaccine on Day 1 (Vaccination 1) and 56 to 70 days after Vaccination 1 (Vaccination 2).
干预措施: 20vPnC (Biological)
Cohort 4
Participants will receive 3 doses of 20vPnC Vaccine on Day 1 (Vaccination 1), 28 to 56 days after Vaccination 1 (Vaccination 2), and at 365 to <455 days of age and at least 56 days after Vaccination 2 (Vaccination 3).
干预措施: 20vPnC (Biological)
Cohort 5
Participants will receive 4 doses of 20vPnC Vaccine on Day 1 (Vaccination 1), 42 to 63 days after Vaccination 1 (Vaccination 2), 42 to 63 days after Vaccination 2 (Vaccination 3), and at 365 to <455 days of age (Vaccination 4).
干预措施: 20vPnC (Biological)
Cohort 6 (20vPnC)
Participants will receive 4 doses of 20vPnC Vaccine on Day 1 (Vaccination 1), 42 to 63 days after Vaccination 1 (Vaccination 2), 42 to 63 days after Vaccination 2 (Vaccination 3), and at 365 to <455 days of age (Vaccination 4).
干预措施: 20vPnC (Biological)
Cohort 6 (13vPnC)
Participants will receive 4 doses of 13vPnC Vaccine on Day 1 (Vaccination 1), 42 to 63 days after Vaccination 1 (Vaccination 2), 42 to 63 days after Vaccination 2 (Vaccination 3), and at 365 to <455 days of age (Vaccination 4).
干预措施: 13vPnC (Biological)
结局指标
主要结局
Percentage of participants reporting prespecified local reactions within 7 days following each study intervention
时间窗: Within 7 days of each study intervention
Prespecified local reactions following each study intervention
Percentage of participants reporting prespecified systemic events within 7 days following each study intervention
时间窗: Within 7 days of each study intervention
Prespecified systemic events following each study intervention
Percentage of participants reporting adverse events (AEs) from the first study intervention through 1 month following the last study intervention administration
时间窗: 1 month after the last vaccination
AEs occurring through 1 month following the last study intervention administration for participants of adults ≥18 to \<50 years of age at the time of consent, and children and infants ≥7 months to \<6 years of age at the time of consent.
Percentage of participants reporting AEs from the first study intervention through 1 month following the third study intervention.
时间窗: From the first study intervention to 1 month after the third study intervention
AEs occurring from the first study intervention through 1 month following the third study intervention in infants ≥42 to ≤98 days of age at the time of consent.
Percentage of participants reporting AEs from the fourth study intervention to 1 month following the fourth study intervention.
时间窗: From the fourth study intervention to 1 month after the fourth study intervention
AEs occurring from the fourth study intervention to 1 month following the fourth study intervention in infants ≥42 to ≤98 days of age at the time of consent.
Percentage of participants reporting serious adverse events (SAEs) throughout the study
时间窗: From the first study intervention to 6 months after the last study intervention
SAEs through 6 months following last study intervention
次要结局
未报告次要终点