Phase 3 Randomized, Double-blind, Placebo-Controlled 3-Lot Study in Healthy Volunteers to Assess Immunogenicity, & Acceptability of a Single-dose of Live Oral Cholera Vaccine, Vibrio Cholerae O1 Serotype Inaba Vaccine Strain CVD 103-HgR
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 3,146
- 试验地点
- 50
- 主要终点
- Geometric Mean Ratio (GMR) at Day 11 for Vaccine Lots A and B
研究概览
简要总结
The primary goal of this Phase III study is to compare 3 lots for consistency of manufacture.
详细描述
The primary goal of this Phase III study is to compare three lots for consistency of manufacture.
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
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy men or women,
- •age 18 to 45 years inclusive;
- •normal medical history and physical examination
- •Women must have a negative pregnancy test.
排除标准
- •travel to a cholera endemic area in the previous 5 years;
- •abnormal stool pattern or regular use of laxatives;
- •Currently active unstable or undiagnosed medical conditions
- •current or recent antibiotic use;
- •pregnancy or nursing;
- •Previously received a licensed or investigational cholera vaccine
- •History of cholera or enterotoxigenic E. coli infection
- •History of Guillain-Barré Syndrome
- •Received or plans to receive any other licensed vaccines, except for seasonal influenza
- •Recipient of bone marrow or solid organ transplant
- •Malignancy (excluding non-melanotic skin cancers) or lymphoproliferative disorders diagnosed or treated during the past 5 years
- •Use of systemic chemotherapy in the previous 5 years prior to the study
- •any immunosuppressive medical condition
结局指标
主要结局
Geometric Mean Ratio (GMR) at Day 11 for Vaccine Lots A and B
时间窗: Day 11
The primary analysis consisted of three between-lot equivalence tests of serum vibriocidal antibody titer measured at Day 11. The GMT of each lot - µA, µB, and µC - was calculated by first log-transforming (base 10) the serum vibriocidal antibody titers, computing the means of the transformed data by lot, and then exponentiating the log-scale means to return to the original, untransformed scale. The resulting GMTs were combined to form three geometric mean ratios: µA/µB, µA/µC, and µB/µC.The ratios were required to be within +/- 50% of each other lot with 95% confidence, which implied that the limits of the 95% confidence interval on each pairwise GMR had to be within 0.67 - 1.5. Placebo GMT values were not included in the primary analysis.
Geometric Mean Ratio (GMR) at Day 11 for Vaccine Lots B and C
时间窗: Day 11
The primary analysis consisted of three between-lot equivalence tests of serum vibriocidal antibody titer measured at Day 11. The GMT of each lot - µA, µB, and µC - was calculated by first log-transforming (base 10) the serum vibriocidal antibody titers, computing the means of the transformed data by lot, and then exponentiating the log-scale means to return to the original, untransformed scale. The resulting GMTs were combined to form three geometric mean ratios: µA/µB, µA/µC, and µB/µC.The ratios were required to be within +/- 50% of each other lot with 95% confidence, which implied that the limits of the 95% confidence interval on each pairwise GMR had to be within 0.67 - 1.5.
Geometric Mean Ratio (GMR) at Day 11 for Vaccine Lots A and C
时间窗: Day 11
The primary analysis consisted of three between-lot equivalence tests of serum vibriocidal antibody titer measured at Day 11. The GMT of each lot - µA, µB, and µC - was calculated by first log-transforming (base 10) the serum vibriocidal antibody titers, computing the means of the transformed data by lot, and then exponentiating the log-scale means to return to the original, untransformed scale. The resulting GMTs were combined to form three geometric mean ratios: µA/µB, µA/µC, and µB/µC.The ratios were required to be within +/- 50% of each other lot with 95% confidence, which implied that the limits of the 95% confidence interval on each pairwise GMR had to be within 0.67 - 1.5.
次要结局
- SVA and Anti-CT IgG GMT at Day 1, 11, 29, 91 and 181(Day 1 - 181)
- SVA and Anti-CT IgG Seroconversion at Day 1, 11, 29, 91 & 181(Day 1 - 181)
- Adverse Events(Day 1 - 29)
- SVA Seroconversion at Day 11(Day 11)