A Phase Ib Randomized, Observer-Blind, Controlled, Single Center, Dose-Ranging Study of a Group B Streptococcus Vaccine in Healthy Women 18-40 Years of Age
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 678
- 试验地点
- 1
- 主要终点
- Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Group 1
研究概览
简要总结
This study will evaluate the safety and immunogenicity of a Group B Streptococcus vaccine.
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
- Single (Investigator)
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
- •Healthy females 18-40 years of age inclusive.
排除标准
- •Individuals who are pregnant or nursing.
- •Individuals who have had a previous immunization with a vaccine containing streptococcus antigens or any vaccine within 30 days of enrollment through 30 days of study completion.
- •Individuals with a history of severe allergic reactions after previous vaccination
- •Individuals with designated blood tests that are not within normal range
结局指标
主要结局
Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Group 1
时间窗: Day 1 and Day 61
The percentage of subjects achieving a specific threshold of antibody concentrations of ≥ 0.5 µg/mL as determined by ELISA at day 61 across cohorts 1 and 2 for potential use in pregnant women.
Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype
时间窗: Day 61/Day 1
Geometric mean ratios (GMRs) relative to baseline (Day 1) of serotype-specific (Ia, Ib, III) GBS IgG antibody levels measured at Day 61 for subjects across cohorts 1 and 2.
Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype at Day 361
时间窗: Day 1 and day 361
GMRs relative to baseline (Day 1) of serotype-specific (Ia, Ib, III) GBS IgG antibody levels in healthy subjects for potential use in non-pregnant women, measured at Day 361 across all cohorts.
Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2
时间窗: Day 1 and Day 361
The percentage of subjects achieving a specific threshold of antibody concentrations of ≥ 0.5 µg/mL at day 361 across all the cohorts for potential use in non-pregnant women.
Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 61
时间窗: Day 1 and Day 61
Serotype-specific (Ia, Ib \& III) group B streptococcus (GBS) IgG antibody levels in healthy subjects for potential use in pregnant woman was assessed in terms of Geometric Mean Concentrations (GMCs) at Day 61 in cohorts 1 and 2.
Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361
时间窗: Day 1 and Day 361
Serotype-specific (Ia, Ib \& III) GBS IgG antibody levels in healthy subjects for potential use in non-pregnant woman was assessed in terms of GMCs at Day 361 across all cohorts.
次要结局
- Number of Participants Reporting Unsolicited AE After Receiving GBS Trivalent Vaccine in Enrollment Group 2(Day 1 through Day 721)
- Number of Participants Reporting Unsolicited AE After Receiving GBS Trivalent Vaccine in Enrollment Group 1(Day 1 through Day 721)
- Geometric Mean Ratios of Serum GBS IgG Antibody Levels By Serotype for Subjects in Enrollment Group 2(Day 1 and Day 721)
- Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype for Subjects in Enrollment Group 1(Day 1 and Day 721)
- Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2(Day 1 to Day 7)
- Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype in Subjects in Enrollment Group 2(Day 1 and Day 721)
- Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1(Day 1 to Day 7)
- Geometric Mean Ratios of Serum GBS IgG Antibody Levels By Serotype for Subjects in Enrollment Group 1(Day 1 and Day 721)