NCT01053767已完成1 期
A Phase I Extension Study to Assess the Long-Term Persistence of GBS Serotypes Ib and III Antibodies in Women Previously Immunized With a GBS Ib and III Crm-Glycoconjugate Vaccine
Novartis Vaccines1 个研究点 分布在 1 个国家目标入组 95 人开始时间: 2010年1月最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 95
- 试验地点
- 1
- 主要终点
- Antibody (Ab) response data at 24-months after the last injection given in study V98P2 GMCs, GMRs and associated 95% confidence intervals will also be determined.
研究概览
简要总结
This study looks at the body's immune response to a GBS vaccine 2 years after the orginal vaccine(s) were given in the V98P2 study. Blood will be drawn and evaluated for GBS antibody levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Individuals who have given written consent.
- •Individuals who participated in V98P2 and received the complete schedule of vaccinations.
排除标准
- •Individuals who have not given written consent.
- •Subjects who did not receive the complete schedule of vaccination in V98P2.
结局指标
主要结局
Antibody (Ab) response data at 24-months after the last injection given in study V98P2 GMCs, GMRs and associated 95% confidence intervals will also be determined.
时间窗: 24- months post last injection from V98P2
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
A Study to Assess the Persistence of a GBS Antibody in Women Previously Immunized With a GBS VaccineGroup B Streptococcus (GBS) DiseaseNCT01052935Novartis50
已完成
不适用
Evaluation of the Long-term Persistence of GlaxoSmithKline (GSK) Biologicals' Candidate Cytomegalovirus (CMV) VaccineInfections, CytomegalovirusNCT01357915GlaxoSmithKline47
已完成
3 期
Long Term F/U Studies at Y5&6 to Demonstrate the Equivalence of 2 Vaccination Schedules of Combined Hepatitis A & B VaccineHepatitis BHepatitis ANCT00197171GlaxoSmithKline143
已完成
3 期
Study Evaluating Persistence Of Antibody Response Elicited By 13vPnC In Healthy Adults Previously VaccinatedHealthyNCT01025336Pfizer962
终止
不适用
Follow-up Study to Evaluate Long-term Safety and Tolerability of Immunization With AD03 Applied During AFF005AAlzheimer's DiseaseNCT01568086Affiris AG16