A PHASE 1, RANDOMIZED, DOUBLE-BLIND, THIRD-PARTY-UNBLINDED STUDY TO EVALUATE THE SAFETY AND TOLERABILITY OF A VACCINE AGAINST E COLI IN HEALTHY ADULTS
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- Pfizer
- 入组人数
- 310
- 试验地点
- 9
- 主要终点
- Percentage of participants reporting prespecified systemic events within 7 days following each vaccination
研究概览
简要总结
This study evaluates an investigational vaccine designed to protect against Escherichia coli (E coli). The primary objective is to assess the safety and tolerability of E coli vaccines administered intramuscularly to healthy adults.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ages Eligible for Study: 18 to 64 Years (Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: Yes
- •Key Inclusion Criteria
- •Adult Participants >= 18 through < 64 years of age at the time of enrollment.
- •Healthy participants as determined by medical history, physical examination, and clinical judgement of the investigator to be eligible for inclusion in the study.
排除标准
- •Severe adverse reaction history associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s).
- •Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
- •Women who are pregnant, plan to become pregnant during the study, or are breastfeeding.
研究组 & 干预措施
E coli vaccine 1 Dose A
Candidate E coli vaccine on day 1 and day 180
干预措施: E coli vaccine 1 Dose A (Drug)
E coli vaccine 1 Dose B
Candidate E coli vaccine on day 1 and day 180
干预措施: E coli vaccine 1 Dose B (Drug)
E coli vaccine 2
Candidate E coli vaccine on day 1 and day 180
干预措施: E coli vaccine 2 (Drug)
E coli vaccine 3
Candidate E coli vaccine on day 1 and day 180
干预措施: E coli vaccine 3 (Drug)
E coli Vaccine 4 Dose A
Candidate E coli vaccine on day 1 and day 180
干预措施: E coli Vaccine 4 Dose A (Drug)
E coli Vaccine 4 Dose B
Candidate E coli vaccine on day 1 and day 180
干预措施: E coli Vaccine 4 Dose B (Drug)
E coli Vaccine 4 Dose C
Candidate E coli vaccine on day 1 and day 180
干预措施: E coli Vaccine 4 Dose C (Drug)
E coli Vaccine 5 Dose A
干预措施: E coli Vaccine 5 Dose A (Drug)
E coli Vaccine 5 Dose B
干预措施: E coli Vaccine 5 Dose B (Drug)
Placebo
Placebo received on day 1 and day 180
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of participants reporting prespecified systemic events within 7 days following each vaccination
时间窗: 7 days after each vaccination
Prespecified systemic events (fever, fatigue, headache, chills, vomiting, diarrhea, joint pain, and muscle pain) following each vaccination
Percentage of participants reporting prespecified local events within 7 days following each vaccination
时间窗: 7 days after each vaccination
Prespecified local reactions (redness, swelling, and pain at the injection site) following each vaccination
Percentage of participants reporting Adverse Events (AEs) from vaccination 1 through 1 month after the last dose of study intervention
时间窗: From signing of ICD to 1 month after the last assigned vaccination
Adverse events occurring up to 1 month after the last dose of study intervention
Percentage of participants reporting Medically Attended Adverse Events (MAEs) from vaccination 1 through 12 months after the last dose of study intervention
时间窗: Baseline up to month 18 with final visit being 12 months after last assigned vaccination
MAEs occurring up to 12 months after the last dose of study intervention
Percentage of participants reporting Serious Adverse Events (SAEs) from vaccination 1 through 12 months after the last dose of study intervention
时间窗: Baseline up to month 18 with final visit being 12 months after last assigned vaccination
SAEs occurring up to 12 months after the last dose of study intervention
次要结局
未报告次要终点