Immunogenicity and Safety Study of GSK Biologicals' dTpa Vaccine, Boostrix™ (263855) in Pregnant Women
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 688
- 试验地点
- 1
- 主要终点
- Antibody Concentrations Against Pertussis Toxoid Antigen (Anti-PT), Filamentous Haemagglutinin Antigen (Anti-FHA) and Pertactin Antigen (Anti-PRN) in Cord Blood Samples
研究概览
简要总结
The purpose of this study is to assess the immunogenicity and safety of Boostrix™ when compared to a placebo given during 27-36 weeks of gestation in healthy women aged 18-45 years. Infants born to mothers enrolled in this study will be followed-up in two separate clinical studies: 201330 [DTPA (BOOSTRIX)-048 PRI] and 201334 [DTPA (BOOSTRIX)-049 BST: 048].
详细描述
The protocol was amended to include Spain in the study. The reasons for the Spain-specific amendment are listed below:
- Based on the feedback from the Spanish Ethics Committee, the evaluation related to the acceptance of cocooning was added in the protocol.
- The objectives and endpoints to include cocooning were added in the protocol.
- The eligibility criteria for participation of household contacts were defined in the protocol.
- The study procedures for household contacts were included.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Control Group
This group will consist of pregnant women who will receive a single dose of placebo at 27-36 weeks (i.e. completed 27 weeks until 36 weeks) of gestation (Visit 1) and will receive a dose of Boostrix™ post-delivery (within 72 hours).
干预措施: Boostrix™ (Biological)
dTpa Group
This group will consist of pregnant women who will receive a single dose of Boostrix™ at 27-36 weeks (i.e. completed 27 weeks until 36 weeks) of gestation (Visit 1) and will receive a dose of the placebo post-delivery (within 72 hours).
干预措施: Boostrix™ (Biological)
dTpa Group
This group will consist of pregnant women who will receive a single dose of Boostrix™ at 27-36 weeks (i.e. completed 27 weeks until 36 weeks) of gestation (Visit 1) and will receive a dose of the placebo post-delivery (within 72 hours).
干预措施: Saline placebo (Drug)
Control Group
This group will consist of pregnant women who will receive a single dose of placebo at 27-36 weeks (i.e. completed 27 weeks until 36 weeks) of gestation (Visit 1) and will receive a dose of Boostrix™ post-delivery (within 72 hours).
干预措施: Saline placebo (Drug)
结局指标
主要结局
Antibody Concentrations Against Pertussis Toxoid Antigen (Anti-PT), Filamentous Haemagglutinin Antigen (Anti-FHA) and Pertactin Antigen (Anti-PRN) in Cord Blood Samples
时间窗: At delivery - Visit 3 (anytime after 28 weeks of gestation)
Antibody concentrations were assessed by Enzyme-linked immunosorbent assay (ELISA), tabulated as Geometric Mean Concentrations (GMCs) and expressed in International units per mililiter (IU/mL) for the following assay cut-offs: 2.693 IU/mL for anti-PT, 2.046 IU/mL for anti-FHA and 2.187 IU/mL for anti-PRN.
次要结局
- Percentage of Subjects by Pregnancy Outcomes(From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study).)
- Percentage of Subjects With Listed Pregnancy/Neonate Related Adverse Events of Interest(From Day 0 (Visit 1) to Month 2 post-delivery (Visit 4, end of the study).)
- Percentage of Seroprotected Subjects Against Diphteria Antigen (Anti-D), Tetanus Antigen (Anti-T) and of Seropositive Subjects Against Anti-PT, Anti-FHA and Anti-PRN(One month post vaccination (Day 30) during pregnancy)
- Number of Subjects With Serious AEs (SAEs)(From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study).)
- Percentage of Infants With Unsolicited AEs(From delivery to Month 2 post delivery (Visit 4, end of the study).)
- Percentage of Seropositive Subjects Against Anti-PT, Anti-FHA and Anti-PRN in the Cord Blood Samples(At delivery - Visit 3 (anytime after 27 eligible weeks of gestation))
- Percentage of Household Contacts of the Infants Born to Pregnant Women Vaccinated in Spain(From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study).)
- Anti-D, Anti-T, Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations(One month post vaccination (Day 30) during pregnancy)
- Percentage of Subjects With Unsolicited AEs(Within 31 days (Day 0 - Day 30) after each vaccination)
- Percentage of Subjects With Vaccine Response to Anti-D and Anti-T(One month post vaccination (Day 30) during pregnancy)
- Percentage of Subjects With Vaccine Response to Anti-PT, Anti-FHA and Anti-PRN(One month post vaccination (Day 30) during pregnancy)
- Percentage of Subjects With Solicited Local Adverse Events (AEs)(During the 8-day (Day 0-Day 7) follow-up period after vaccination during pregnancy)
- Percentage of Subjects With Solicited General AEs(During the 8-day (Day 0-Day 7) follow-up period after vaccination during pregnancy)
- Percentage of Household Contacts With SAEs(During the 31-day (Days 0-30) follow-up period post-vaccination (Boostrix administered preferably 2 weeks before the birth of the infant, Visit 3).)