NCT01033877已完成3 期
Immunogenicity and Safety of a Tetanus, Diphtheria and Mono Component Acellular Pertussis (TdaP) Vaccine in Comparison to a Tetanus and Diphtheria (Td) Vaccine When Given as a Booster Vaccination to Adults
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 802
- 试验地点
- 2
- 主要终点
- Three co-primary outcome measures: Serum anti-PTx antibody conc. in pre- and post-vac. serum samples
研究概览
简要总结
The clinical trial is a phase III, double-blind, randomised, controlled, multi-centre, clinical trial, on the immunogenicity and safety of TdaP vaccine in comparison to Td vaccine when given as a booster vaccination to adults who were vaccinated with D, T and wP vaccine according to the Danish vaccination programme in their childhood.
Healthy, adult, female or male volunteers, who completed primary vaccination with diphtheria (D), tetanus (T) and whole cell pertussis vaccine (wP), typically during their childhood, is the target population.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy female or male adult of ≥ 18 years of age
- •Completed primary vaccination with diphtheria (D), Tetanus (T) and whole cell pertussis (wP) vaccines in Denmark
- •Signed informed consent
- •Prepared to grant authorised persons access to medical records
- •Likely to comply with instructions
排除标准
- •Congenital or acquired immunodeficiency or progressive neurologic disease
- •Uncontrolled epilepsy or progressive encephalopathy
- •Previous experience of serious adverse reaction(s) after vaccinations with diphtheria-, tetanus- acellular or whole cell pertussis- vaccines
- •Vaccinated with any diphtheria, tetanus or pertussis toxoid containing vaccine within 5 years before inclusion
- •Vaccinated with any tetanus toxoid, diphtheria toxoid or diphtheria CRM197 protein conjugated vaccine within 5 years before inclusion
- •Known tetanus-, diphtheria- or pertussis disease/infection within 5 years before inclusion
- •Known hypersensitivity or history of allergic reactions to any of the active or inactive constituents of the TdaP or Td vaccines
- •Vaccinated with a live or inactivated vaccine within 1 month before inclusion
- •Administration of immune modulating drugs (such as immunoglobulin, systemic corticosteroids, blood products, azathioprine, cyclosporine, infliximab) within 3 months before inclusion
- •Administration of any investigational drug product or vaccine within 1 month before inclusion
- •Females if pregnant or breastfeeding or not willing to use contraception during the trial
研究组 & 干预措施
TdaP vaccine
Experimental
干预措施: TdaP vaccine SSI (Biological)
Td vaccine
Active Comparator
干预措施: Td vaccine SSI (Biological)
结局指标
主要结局
Three co-primary outcome measures: Serum anti-PTx antibody conc. in pre- and post-vac. serum samples
时间窗: one month post-vaccination
Serum anti-diphtheria antibody conc. in post-vac. serum samples
时间窗: one month post -vaccination
Serum anti-tetanus antibody conc. in post-vac. serum samples
时间窗: one month post-vaccination
次要结局
- Three secondary outcome measures: Local and systemic adverse events reported during one month following the vaccination(one month post-vaccination)
- Serum anti-diphtheria antibody conc. in pre-vac. serum samples(one month post-vaccination)
- Serum anti-tetanus antibody conc. in pre-vac. serum samples(one month post- vaccination)
研究者
研究点 (2)
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