A PHASE 1, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN STUDY TO DESCRIBE THE SAFETY AND TOLERABILITY OF A MULTIVALENT PNEUMOCOCCAL CONJUGATE VACCINE IN ADULTS
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Pfizer
- 入组人数
- 380
- 试验地点
- 25
- 主要终点
- Percentage of participants reporting serious adverse events.
研究概览
简要总结
The purpose of this study is to learn about the safety and tolerability of a pneumococcal vaccine in adults.
Participants will receive either:
- an experimental PG4 vaccine
- a PG4 vaccine comparator
- a standard 20vPnC vaccine comparator
- placebo. A placebo does not have any medicine in it but looks just like the study medicine.
Participants will take part in this study for up to 18 months depending on which group they are assigned to. During this time, the participants will receive up to two doses of study vaccine or comparator and take part in follow-up visits.
At these clinic visits, participants will be asked if any side effects were experienced. The participants will also have to give blood samples during clinic 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 65 Years 至 84 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study.
- •Participants either with no history of ever receiving a pneumococcal vaccine or who have received a pneumococcal vaccine more than 5 years prior to vaccination in this study
排除标准
- •Participants with a history of microbiologically proven invasive disease caused by S pneumoniae.
研究组 & 干预措施
PG4 vaccine; dose schedule 1
干预措施: PG4 vaccine in Buffer 2 (Biological)
20vPnC; dose schedule 1
干预措施: 20-valent pneumococcal conjugate vaccine (Biological)
20vPnC; dose schedule 1
干预措施: Saline injection (Biological)
20vPnC; dose schedule 2
干预措施: 20-valent pneumococcal conjugate vaccine (Biological)
20vPnC; dose schedule 2
干预措施: Saline injection (Biological)
PG4 vaccine with high dose adjuvant PA-002; dose schedule 1
干预措施: PG4 vaccine in Buffer 1 with high dose PA-002 (Biological)
PG4 vaccine with low dose adjuvant PA-002; dose schedule 2
干预措施: PG4 in Buffer 1 with low dose PA-002 (Biological)
PG4 vaccine with low dose adjuvant PA-001; dose schedule 1
干预措施: PG4 vaccine in Buffer 1 with low dose PA-001 (Biological)
PG4 vaccine with low dose adjuvant PA-002; dose schedule 1
干预措施: PG4 in Buffer 1 with low dose PA-002 (Biological)
PG4 vaccine with high dose adjuvant PA-001; dose schedule 1
干预措施: PG4 in Buffer 1 with high dose PA-001 (Biological)
PG4 vaccine with low dose adjuvant PA-001; dose schedule 2
干预措施: PG4 vaccine in Buffer 1 with low dose PA-001 (Biological)
PG4 vaccine with high dose adjuvant PA-001; dose schedule 2
干预措施: PG4 in Buffer 1 with high dose PA-001 (Biological)
PG4 vaccine with high dose adjuvant PA-002; dose schedule 2
干预措施: PG4 vaccine in Buffer 1 with high dose PA-002 (Biological)
PG4 vaccine; dose schedule 1
干预措施: Saline injection (Biological)
PG4 vaccine; dose schedule 2
干预措施: Saline injection (Biological)
PG4 vaccine; dose schedule 2
干预措施: PG4 vaccine in Buffer 2 (Biological)
结局指标
主要结局
Percentage of participants reporting serious adverse events.
时间窗: From signing of the ICD to 6 months after the last study intervention.
Serious Adverse Events (SAEs) occurring from Dose 1 through 6 months after the last vaccination.
Percentage of participants reporting prespecified local reactions after each dose.
时间窗: Within 7 days after each study intervention.
Prespecified local reactions (redness, swelling, and pain at the injection site) occurring within 7 days of each dose administered in the study.
Percentage of participants reporting prespecified systemic reactions after each dose.
时间窗: Within 7 days after each study intervention.
Prespecified systemic reactions (fever, vomiting, diarrhea, headache, fatigue, muscle pain, and joint pain) occurring within 7 days of each dose administered in the study.
Percentage of participants reporting adverse events.
时间窗: From signing of the ICD to 1 month after last study intervention.
Adverse Events (AEs) occurring from Dose 1 through 1 month after the last vaccination
Percentage of participants reporting serious adverse events.
时间窗: From signing of the ICD to 12 months after the last study intervention.
Serious Adverse Events (SAEs) occurring from Dose 1 through 12 months after the last vaccination.
Percentage of participants with abnormal hematology and chemistry laboratory values.
时间窗: Within 2 weeks after each study intervention.
Any abnormal hematology or chemistry laboratory values as compared to baseline within 2 weeks after each study intervention.
Percentage of participants reporting prespecified local reactions after each dose.
时间窗: Within 7 days after each study intervention.
Prespecified local reactions (redness, swelling, and pain at the injection site) occurring within 7 days of each dose administered in the study.
Percentage of participants reporting prespecified systemic reactions after each dose.
时间窗: Within 7 days after each study intervention.
Prespecified systemic reactions (fever, vomiting, diarrhea, headache, fatigue, muscle pain, and joint pain) occurring within 7 days of each dose administered in the study.
Percentage of participants reporting adverse events.
时间窗: From signing of the ICD to 1 month after last study intervention.
Adverse Events (AEs) occurring from Dose 1 through 1 month after the last vaccination
Percentage of participants reporting serious adverse events.
时间窗: From signing of the ICD to 12 months after the last study intervention.
Serious Adverse Events (SAEs) occurring from Dose 1 through 12 months after the last vaccination.
Percentage of participants with abnormal hematology and chemistry laboratory values.
时间窗: Within 2 weeks after each study intervention.
Any abnormal hematology or chemistry laboratory values as compared to baseline within 2 weeks after each study intervention.
次要结局
未报告次要终点