A Phase Ib/II Randomized, Observer-Blind, Controlled, Single Centre Study of a Trivalent Group B Streptococcus Vaccine in Healthy Non-Pregnant Women Leading Into a Dose-Ranging Study in Pregnant Women in South Africa
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 380
- 试验地点
- 1
- 主要终点
- The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold at Day of Delivery.
研究概览
简要总结
This study will evaluate the safety and immunogenicity of a Group B Streptococcus vaccine at one dose in healthy non pregnant women and then in three different doses in healthy pregnant women.
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 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Group 1 (Non Pregnant Women): Healthy females 18-40 years of age inclusive.
- •Group 2 (Healthy Pregnant Women): Healthy pregnant women 18-40 yrs of age (between 28-35 weeks gestation)
排除标准
- •Group 1 (Non Pregnant Women): Pregnant or nursing; History of severe allergy to previous vaccines; Known HIV positive
- •Group 2 (Healthy Pregnant Women): History of severe allergy to previous vaccines; Known HIV positive
结局指标
主要结局
The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold at Day of Delivery.
时间窗: Day of delivery
The percentages of maternal subjects with antibody concentrations above a defined threshold per serotype following the administration of one of three different doses of the study vaccine or placebo.Antibody concentrations which exceed pre-defined serotype specific ELISA values are 1, 2, 3, 5 and 8 μg/mL.
The Percentages of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Month After the Second Vaccination.
时间窗: Day 61, one month after the second vaccination
The percentages of non-pregnant subjects with antibody concentrations above a defined threshold per serotype after the administration of two vaccine doses administered one month apart. Defined thresholds for antibody concentrations, which exceed pre-defined serotype specific ELISA values are 1, 2, 3, 5 and 8 μg/mL.
Antibody Geometric Mean Concentrations (GMC) in Non-pregnant Women at One Month After the Second Vaccination.
时间窗: Day 61, one month after the second vaccination
Antibody GMC per serotype in non-pregnant women after receiving two doses of the study vaccine administered one month apart .
Antibody GMC in Maternal Subjects at Day of Delivery
时间窗: Day of delivery
Antibody GMC per serotype in maternal subjects at day of delivery following one administration of one of three different doses of the study vaccine or placebo are reported.
次要结局
- The Percentage of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Year After the First Vaccination.(Day 361, one year after the first vaccination)
- Antibody GMC in Non-pregnant Subjects at One Year After the First Vaccination(Day 361, one year after the first vaccination)
- The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold Per Serotype at One Month After Vaccination.(Day 31, one month after vaccination)
- Number of Non-pregnant Subjects Reporting Solicited and Unsolicited Adverse Events(Day 61)
- Number of Maternal Subjects Reporting Solicited and Unsolicited Adverse Events(From day 1 to one year after delivery)
- Antibody GMC Per Serotype in Maternal Subjects at One Month After Vaccination(day 31)
- Antibody GMC Per Serotype at Different Time Points in Infants(Day 4, day 43 and day 91 after birth)
- Number of Infants Reporting Serious Adverse Events(one year after birth)