EUCTR2015-005196-24-Outside-EU/EEA进行中（未招募）不适用
Three-, Five-, and Ten-Year Data on the Long-Term Immunogenicity of Tetanus and Diphtheria Toxoids AdsorbedCombined with Component Pertussis Vaccine and Inactivated Poliomyelitis Vaccine (TdcP-IPV) in Adolescents 11–14 Years of Age
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 174
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1) Age 11 years and < 14 years of age.
- •2) Signed, witnessed and dated informed consent that is obtained prior to the first study intervention.
- •3) Judged to be in good health on the basis of reported medical history.
- •4) Plans to remain in the study area for the length of the trial.
- •5) All minors have a parent or legal guardian who can read, write and understand English or French.
- •6) Pregnancy test to be performed on all female participants at the time of enrollment into the study (prior to day of first immunization visit).
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 174
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1) Pregnancy.
- •2) Known or suspected primary disease of the immune system [conditions suspected of having an immunologic component such as autoimmune diseases (rheumatoid arthritis or inflammatory bowel disease) will not be excluded unless they meet exclusion criterion 3 or are sufficiently clinically active to meet exclusion criterion 5].
- •3) Malignancy or is receiving immunosuppressive therapy (e.g., daily systemic prednisone = 1 mg/kg would be excluded, participants who are taking topical and inhaled steroids could be included in the study as could participants on a short course of oral steroids, 5-7 days, as long as there are not two courses within the previous two week period).
- •4) Prior receipt of any pertussis, diphtheria, tetanus or polio containing vaccines, including Hepatitis B vaccine, within the past 5 years.
- •5) Any significant underlying chronic disease, including malignancy, cardiopulmonary disease, renal or hepatic dysfunction.
- •6) Known impairment of neurologic function or seizure disorder of any etiology.
- •7) Personal history of physician diagnosed or laboratory confirmed pertussis disease within the last 2 years.
- •8) Receipt of blood products or immunoglobulin within the previous 3 months.
- •9) Known or suspected allergy to any of the vaccines intended for use in the study or any of the vaccine components including neomycin, streptomycin and polymyxin B.
- •10) Receipt of any vaccine within 2 weeks of receiving a study vaccine.
- •11) Daily use of non-steroidal anti-inflammatory drugs.
研究者
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