NCT02014519已完成不适用
Seroprevalence of Bordetella Pertussis in Adults in Hungary
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,000
- 试验地点
- 6
- 主要终点
- Number of Seropositive Subjects in Terms of Anti-pertussis Toxin (Anti-PT) Concentrations
研究概览
简要总结
The purpose of this study is to perform an epidemiological survey of the adult population in Hungary to calculate the seroprevalence of pertussis.
详细描述
The protocol posting was amended to correct the detailed title. Since a sample of blood will be collected from all subjects (outside of routine hospital procedure), the study does not meet GSK's definition of an observational study and hence the term "observational" was deleted from the detailed title.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •Subjects who the investigator believes can and will comply with the requirements of the protocol.
- •Written informed consent will be obtained from subjects prior to performing any study procedures.
- •Males or females ≥ 18 years of age at the time of enrollment.
- •Agreeing to collection of a blood sample for the study.
排除标准
- •Confirmed or suspected immunological disorder.
结局指标
主要结局
Number of Seropositive Subjects in Terms of Anti-pertussis Toxin (Anti-PT) Concentrations
时间窗: At the time of enrollment of each subject (Day 0)
Seropositivity was defined as anti-PT IgG levels above the sensitivity limit of the assay (\> 0.3 Optical Density (OD) units)
Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection
时间窗: At the time of enrollment of each subject (Day 0)
The cut-off value for anti-PT IgG levels indicative of current/recent infection was greater than or equal to (≥) 1.0 OD units.
Number of Seronegative Subjects in Terms of Anti-PT Concentrations
时间窗: At the time of enrollment of each subject (Day 0)
Seronegativity was defined as anti-PT IgG levels under the sensitivity limit of the assay (≤ 0.3 OD units)
Number of Subjects With Anti-PT IgG Levels Strongly Indicative of Current/Recent Infection
时间窗: At the time of enrollment of each subject (Day 0)
The cut-off value for anti-PT IgG levels strongly indicative of current/recent infection was greater than or equal to (≥) 1.5 OD units
次要结局
- Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by Gender)(At the time of enrollment of each subject (Day 0))
- Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by History of Pertussis)(At the time of enrollment of each subject (Day 0))
- Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by History of Pertussis)(At the time of enrollment of each subject (Day 0))
- Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection (by History of Vaccination Against Pertussis)(At the time of enrollment of each subject (Day 0))
- Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by Medication)(At the time of enrollment of each subject (Day 0))
- Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by Age)(At the time of enrollment of each subject (Day 0).)
- Number of Subjects With Anti-PT IgG Levels Strongly Indicative of Current/Recent Infection (by Age)(At the time of enrollment of each subject (Day 0))
- Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection (by Age)(At the time of enrollment of each subject (Day 0))
- Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by Age)(At the time of enrollment of each subject (Day 0))
- Number of Subjects With Anti-PT IgG Levels Not Indicative of Current/Recent Infection (by Gender)(At the time of enrollment of each subject (Day 0))
- Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by Recent History of Long-lasting Cough)(At the time of enrollment of each subject (Day 0))
- Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by Recent History of Long-lasting Cough)(At the time of enrollment of each subject (Day 0))
- Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by Gender)(At the time of enrollment of each subject (Day 0))
- Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by Smoking Status)(At the time of enrollment of each subject (Day 0))
- Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by Smoking Status)(At the time of enrollment of each subject (Day 0))
- Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by History of Vaccination Against Pertussis)(At the time of enrollment of each subject (Day 0))
- Number of Subjects With Anti-PT IgG Levels Not Indicative of Current/Recent Infection (by History of Vaccination Against Pertussis)(At the time of enrollment of each subject (Day 0))
- Number of Subjects With Anti-PT IgG Levels Strongly Indicative of Current/Recent Infection (by Gender)(At the time of enrollment of each subject (Day 0))
- Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection (by Gender)(At the time of enrollment of each subject (Day 0))
- Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection (by Recent History of Long-lasting Cough)(At the time of enrollment of each subject (Day 0))
- Number of Subjects With Anti-PT IgG Levels Not Indicative of Current/Recent Infection (by Recent History of Long-lasting Cough)(At the time of enrollment of each subject (Day 0))
- Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection (by Smoking Status)(At the time of enrollment of each subject (Day 0))
- Number of Subjects With Anti-PT IgG Levels Not Indicative of Current/Recent Infection (by Smoking Status)(At the time of enrollment of each subject (Day 0))
- Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection (by History of Pertussis)(At the time of enrollment of each subject (Day 0))
- Number of Subjects With Anti-PT IgG Levels Not Indicative of Current/Recent Infection (by History of Pertussis)(At the time of enrollment of each subject (Day 0))
- Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by History of Vaccination Against Pertussis)(At the time of enrollment of each subject (Day 0))
- Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by Medication)(At the time of enrollment of each subject (Day 0))
- Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection (by Medication)(At the time of enrollment of each subject (Day 0))
- Number of Subjects With Anti-PT IgG Levels Not Indicative of Current/Recent Infection (by Medication)(At the time of enrollment of each subject (Day 0))
- Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by Hospitalization)(At the time of enrollment of each subject (Day 0))
- Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by Hospitalization)(At the time of enrollment of each subject (Day 0))
- Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection (by Hospitalization)(At the time of enrollment of each subject (Day 0))
- Number of Subjects With Anti-PT IgG Levels Not Indicative of Current/Recent Infection (by Hospitalization)(At the time of enrollment of each subject (Day 0))
研究者
研究点 (6)
Loading locations...
相似试验
已完成
不适用
Pertussis Infection in Adolescents and Adults With Prolonged CoughPertussisNCT01597687GlaxoSmithKline337
已完成
早期 1 期
Seroprevalence of Bordetella Pertussis Antibodies and Anti-pertussis Antibody Response After a Single Dose of Tdap in Pregnant Thai WomenPregnancy RelatedPertussisNCT03498300Mahidol University129
Unknown
不适用
Bordetella Pertussis Carriage in College-aged StudentsCarriage of Bordetella PertussisNCT02215564University of Virginia150
Unknown
不适用
Seroprevalence of Pertussis Among Children and Adolescents in CroatiaImmunogenicity, VaccineNCT04725669University Hospital for Infectious Diseases, Croatia1,500
Unknown
4 期
Vaccination Against Pertussis, Tetanus and Diphtheria in Patients Suffering From Rheumatoid ArthritisRheumatoid ArthritisNCT01301703Tel-Aviv Sourasky Medical Center100