A PHASE 3, PLACEBO-CONTROLLED, DOUBLE-BLINDED, RANDOMIZED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF A CLOSTRIDIOIDES DIFFICILE VACCINE IN ADULTS 65 YEARS OF AGE AND OLDER
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Pfizer
- 入组人数
- 32,500
- 试验地点
- 297
- 主要终点
- The percentage of participants reporting local reactions
研究概览
简要总结
The purpose of the study is to learn about how effective, safe, and tolerable the Clostridioides difficile (C. difficile) vaccine is in decreasing the number of C. difficile infections (pCDI) in adults 65 years of age or older.
The participants will receive either the C. difficile vaccine or placebo (saline). A placebo does not contain any active ingredients. The vaccines will be given as a shot into the upper arm muscle.
This study looks at the number of diarrhea (loose stools) events related to a C. difficile infection, so the length of the study can change. If these events happen quickly, the study may finish sooner; if they happen slowly, it could take longer. Sometimes, the study might stop early if the vaccine clearly does not work. Participants will stay in the study until enough events have occurred to answer the main question. On average, each person is expected to take part for up to about three and a half years.
During this time, participants will have 3 planned clinic visits and 3 planned phone visits. After these visits, more scheduled clinic visits will happen every year until the end of study.
Besides the scheduled study visits, if at any time during the study a participant has 3 or more loose stools in 24 hours, they will be asked to save the next one (the fourth or later) and contact the study site. The study site will check to see if it could be a C. difficile infection. This check may happen at the clinic or through a phone or video call.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Who Can Join the Study (Inclusion Criteria):
- •People with recent or future planned contact with healthcare systems, recent antibiotic exposure, or a diagnosis of certain chronic medical conditions.
- •Who Cannot Join the Study (
排除标准
- •Anyone who has had CDI before.
- •Anyone who has had surgery to remove part of their small or large intestine.
- •Anyone who often has diarrhea (meaning three or more loose stools in a day, more than once a month).
- •Anyone who has already received a vaccine or special antibody treatment for C. difficile.
- •Anyone who has had a serious allergic reaction to a vaccine or to any part of the study vaccines.
- •Anyone who might not respond well to the vaccine because their immune system is weak (either from a disease or from treatment).
- •Anyone with cancer that has spread or another serious health problem.
研究组 & 干预措施
C.difficile vaccine
Novel vaccine formulation
干预措施: C.difficile vaccine (Biological)
Saline Placebo
干预措施: Saline Placebo (Other)
结局指标
主要结局
The percentage of participants reporting local reactions
时间窗: For 7 days after each vaccination
Injection site pain, redness, and swelling as self-reported in electronic diaries
The percentage of participants reporting systemic events
时间窗: For 7 days after each vaccination
Fever, vomiting, fatigue, headache, muscle pain, and joint pain as self-reported in electronic diaries
Percentage of participants reporting adverse events
时间窗: From each vaccination through 1 month after each vaccination
As elicited by investigator site staff
Percentage of participants reporting serious adverse events
时间窗: From Vaccination 1 (Day 1) through 12 months after Vaccination 2 (last dose) (18 months)
As elicited by investigator site staff
The incidence of the first episode of medically attended and clinically meaningful primary Clostridioides difficile infection (CDI)
时间窗: from 14 days after Vaccination 2 to the end of the surveillance period (up to approximately 3.5 years)
First episode of medically attended and clinically meaningful primary CDI incidence per 1000 person- years of follow- up
The incidence of the first episode of medically attended primary CDI
时间窗: from 14 days after Vaccination 2 to the end of the surveillance period (up to approximately 3.5 years)
First episode of medically attended primary CDI incidence per 1000 person- years of follow- up
The incidence of the first episode of clinically meaningful primary CDI
时间窗: from 14 days after Vaccination 2 to the end of the surveillance period (up to approximately 3.5 years)
First episode of clinically meaningful primary CDI incidence per 1000 person- years of follow- up
The percentage of participants reporting local reactions
时间窗: For 7 days after each vaccination
Injection site pain, redness, and swelling as self-reported in electronic diaries
The percentage of participants reporting systemic events
时间窗: For 7 days after each vaccination
Fever, vomiting, fatigue, headache, muscle pain, and joint pain as self-reported in electronic diaries
Percentage of participants reporting adverse events
时间窗: From each vaccination through 1 month after each vaccination
As elicited by investigator site staff
Percentage of participants reporting serious adverse events
时间窗: From Vaccination 1 (Day 1) through 12 months after Vaccination 2 (last dose) (18 months)
As elicited by investigator site staff
The incidence of the first episode of medically attended and clinically meaningful primary Clostridioides difficile infection (CDI)
时间窗: from 14 days after Vaccination 2 to the end of the surveillance period (up to approximately 3.5 years)
First episode of medically attended and clinically meaningful primary CDI incidence per 1000 person- years of follow- up
The incidence of the first episode of medically attended primary CDI
时间窗: from 14 days after Vaccination 2 to the end of the surveillance period (up to approximately 3.5 years)
First episode of medically attended primary CDI incidence per 1000 person- years of follow- up
The incidence of the first episode of clinically meaningful primary CDI
时间窗: from 14 days after Vaccination 2 to the end of the surveillance period (up to approximately 3.5 years)
First episode of clinically meaningful primary CDI incidence per 1000 person- years of follow- up
次要结局
- The incidence of antibiotic use in the treatment of a first episode of the primary CDI(from 14 days after Vaccination 2 to the end of the surveillance period (up to approximately 3.5 years))
- The incidence of severe primary CDI as defined by Infectious Diseases Society of America (IDSA)/ Society for Healthcare Epidemiology of America (SHEA)(from 14 days after Vaccination 2 to the end of the surveillance period (up to approximately 3.5 years))
- The incidence of a first episode of primary CDI (any severity)(from 14 days after Vaccination 2 to the end of the surveillance period (up to approximately 3.5 years))
- The incidence of all CDI (primary and recurrent)(from 14 days after Vaccination 2 to the end of the surveillance period (up to approximately 3.5 years))
- The incidence of severe or fulminant primary CDI(from 14 days after Vaccination 2 to the end of the surveillance period (up to approximately 3.5 years))
- The incidence of antibiotic use in the treatment of a first episode of the primary CDI(from 14 days after Vaccination 2 to the end of the surveillance period (up to approximately 3.5 years))
- The incidence of severe primary CDI as defined by Infectious Diseases Society of America (IDSA)/ Society for Healthcare Epidemiology of America (SHEA)(from 14 days after Vaccination 2 to the end of the surveillance period (up to approximately 3.5 years))
- The incidence of a first episode of primary CDI (any severity)(from 14 days after Vaccination 2 to the end of the surveillance period (up to approximately 3.5 years))
- The incidence of all CDI (primary and recurrent)(from 14 days after Vaccination 2 to the end of the surveillance period (up to approximately 3.5 years))