A Phase 4 Study to Assess the Safety and Immunogenicity of VAXCHORA (Cholera Vaccine, Live, Oral) in Children 2 to <18 Years of Age
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 550
- 试验地点
- 20
- 主要终点
- Cohort 2 (6 to <12 Years) Primary Endpoint - Seroconversion of Serum Vibriocidal Antibody Against V. Cholerae
研究概览
简要总结
VAXCHORA (Cholera Vaccine, Live, Oral) is a vaccine indicated for active immunization against disease caused by Vibrio cholerae serogroup O1. VAXCHORA is approved for use in adults 18 through 64 years of age travelling to cholera-affected areas. The primary goals of this Phase 4 study are to evaluate the safety and immunogenicity of a single dose of VAXCHORA (1 x 10e9 cfu/dose) in children ages 2 years to <18 years of age in developed countries.
详细描述
This is a randomized, placebo-controlled, double-blind, single-crossover study with three age cohorts and two treatment groups within each cohort.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The study will be conducted as a double-blind study through 181, where neither the sponsor, the statistical team, study volunteer subjects, nor clinical site personnel (except for the unblinded administration staff) will know subjects' treatment assignment. Once each subject has reached their Day 181 visit they will be individually unblinded.
入排标准
- 年龄范围
- 2 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or Female
- •Between 2 and <18 years of age on Day 1
- •In general good health
- •Able and willing to provide informed assent for study participation
- •Primary caregiver is able and willing to provide informed consent for study participation
- •(for females of childbearing potential) Using an acceptable method of contraception through Day 29
排除标准
- •Current acute gastrointestinal illness or loose stools within 3 days of Day 1 visit
- •Current acute febrile illness
- •History of cholera infection
- •History of cholera vaccination
- •History of severe allergic reaction (e.g. anaphylaxis) to any ingredient of VAXCHORA
- •Congenital or acquired immunodeficiency
- •Pregnancy (for females of childbearing potential)
- •Any other condition that, in the opinion of the Investigator, creates an unacceptable risk to the subject
- •Any other condition that, in the opinion of the Investigator, will interfere with the conduct of the study or the validity of the data
- •Duration of >2 weeks of abnormal stool pattern, defined as <3 stools per week or >2 stools per day in the past 6 months
- •Regular use of laxatives in the past 6 months
- •History of enterotoxigenic E. coli infection
- •Travel to cholera-endemic area in the previous 5 years
- •Nursing/Breastfeeding
- •Received or plans to receive the following from 14 days prior to the study vaccination through 11 days after vaccination: Any other licensed vaccines, antibiotics, or chloroquine
- •Received or plans to receive any other investigational agent throughout the main study (Day 181)
结局指标
主要结局
Cohort 2 (6 to <12 Years) Primary Endpoint - Seroconversion of Serum Vibriocidal Antibody Against V. Cholerae
时间窗: Day 11
The proportion of subjects achieving seroconversion of serum vibriocidal antibody (SVA) against the classical Inaba biotype of V. cholerae at Day 11 following one dose of VAXCHORA, defined as a 4-fold or greater rise over baseline Day 1 SVA titer.
Cohort 3 (2 to <6 Years) Primary Endpoint - Seroconversion of Serum Vibriocidal Antibody Against V. Cholerae
时间窗: Day 11
The proportion of subjects achieving seroconversion of serum vibriocidal antibody (SVA) against the classical Inaba biotype of V. cholerae at Day 11 following one dose of VAXCHORA, defined as a 4-fold or greater rise over baseline Day 1 SVA titer.
Cohort 2 (6-11 Yrs) Primary Endpoint - Non-inferiority of Seroconversion Rate at Day 11 Relative to Adults Aged 18 - 45 Years
时间窗: Day 11
The seroconversion rate is defined as the percentage of subjects with a 4-fold or greater rise over baseline Day 1 Serum Vibriocidal Antibody (SVA) titer against the classical Inaba biotype of V. cholerae at Day 11 following one dose of Vaxchora vaccine. The hypothesis was that the pediatric seroconversion rate would be non-inferior to the seroconversion rate at Day 11 in adults between the ages of 18 and 45 years.
Cohort 1 (12-17 Yrs) Primary Endpoint - Seroconversion of Serum Vibriocidal Antibody Against V. Cholerae
时间窗: Day 11
The proportion of subjects achieving seroconversion of serum vibriocidal antibody (SVA) against the classical Inaba biotype of V. cholerae at Day 11 following one dose of VAXCHORA, defined as a 4-fold or greater rise over baseline Day 1 SVA titer
Cohort 1 (12-17 Yrs) Primary Endpoint - Non-inferiority of Seroconversion Rate at Day 11 Relative to Adults Aged 18 - 45 Years
时间窗: Day 11
The seroconversion rate is defined as the percentage of subjects with a 4-fold or greater rise over baseline Day 1 Serum Vibriocidal Antibody (SVA) titer against the classical Inaba biotype of V. cholerae at Day 11 following one dose of Vaxchora vaccine. The hypothesis was that the pediatric seroconversion rate would be non-inferior to the seroconversion rate at Day 11 in adults between the ages of 18 and 45 years.
Cohort 3 (2-5 Yrs) Primary Endpoint - Non-inferiority of Seroconversion Rate at Day 11 Relative to Adults Aged 18 - 45 Years
时间窗: Day 11
The seroconversion rate is defined as the percentage of subjects with a 4-fold or greater rise over baseline Day 1 Serum Vibriocidal Antibody (SVA) titer against the classical Inaba biotype of V. cholerae at Day 11 following one dose of Vaxchora vaccine. The hypothesis was that the pediatric seroconversion rate would be non-inferior to the seroconversion rate at Day 11 in adults between the ages of18 and 45 years.
次要结局
- Cohort 1 (12 to <18 Years) - Seroconversion of SVA - Day 730(Day 730)
- Cohort 1 (12 to <18 Years) - Seroconversion of SVA - Day 29(Day 29)
- Cohort 1 (12 to <18 Years) - Seroconversion of SVA - Day 181(Day 181)
- Cohort 1 (12 to <18 Years) - Seroconversion of SVA - Day 91(Day 91)
- Cohort 1 (12 to <18 Years) - Seroconversion of SVA - Day 365(Day 365)
- Cohort 1 (12 to <18 Years) - Seroconversion of SVA - Day 547(Day 547)
- Cohort 2 (6 to <12 Years) - Seroconversion of SVA - Day 29(Day 29)
- Cohort 3 (2 to <6 Years) - Seroconversion of SVA - Day 29(Day 29)