EUCTR2015-005843-15-Outside-EU/EEA进行中（未招募）不适用
One-, Three-, Five-, Eight- and Ten-Year Data on the Long- Term Immunogenicity of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap) in Adults and Adolescents
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
- 144
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
- •Subjects who were enrolled in Groups 3, 4 and 5 of the original Study TC9704, received Tdap Vaccine and provided blood samples.
- •Subjects in the other 2 study groups did not receive the investigational vaccine and thus were not followed for long-term immunogenicity (LTI) assessment.
- •Inclusion criteria are the same as in the original study (Td9704):
- •1. Age =12 years but <55 years of age.
- •2. Signed, witnessed and dated informed consent that was obtained prior to the first study intervention.
- •3. Judged to be in good health on the basis of medical history.
- •4. Able to cooperate with requirements of the study (i.e. able to speak, read and write English, have home telephone, expect to be available for adverse event monitoring for at least 3 months after the immunization).
- •5. If the participant was female, she confirmed she was using an effective method of contraception for the length of the trial and had a negative pregnancy test prior to vaccination OR had had a history of tubal ligation OR hysterectomy OR was post menopausal (at least 1 year no menses) from the
- •initiation of the study OR their only sexual partner had been sterilized (if male). (Effective method of contraception included abstinence, oral contraceptives, IUDs, diaphragm or condom providing they are used with contraceptive foam, sponge or cream.)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 144
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Exclusion criteria are the same as in the original study (Td9704):
- •1. Pregnancy or planning a pregnancy during the study period.
- •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 receiving immunosuppressive therapy (e.g. daily systemic prednisone =1 mg/kg would be excluded. Participants who were 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 were not two courses within the previous two week period.)
- •4. Receipt of any pertussis, diphtheria or tetanus containing vaccines within the previous 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 previous 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.
- •10. Receipt of any vaccine within 2 weeks of receiving a study vaccine.
- •11. Daily use of non-steroidal anti-inflammatory drugs (NSAIDS).
研究者
相似试验
进行中（未招募）
不适用
One-, Three-, Five- and Ten-Year Data on the Long-Term Immunogenicity of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap) in Adolescents 11–14 Years of AgeActive immunization against tetanus, diphtheria and pertussisMedDRA version: 18.1Level: PTClassification code 10054129Term: Diphtheria immunisationSystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 18.1Level: PTClassification code 10069577Term: Pertussis immunisationSystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 18.1Level: PTClassification code 10054131Term: Tetanus immunisationSystem Organ Class: 10042613 - Surgical and medical proceduresEUCTR2015-005844-32-Outside-EU/EEASanofi Pasteur Limited150
进行中（未招募）
不适用
A Follow-Up To Study Td506: Safety and Immunogenicity of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap) Compared to Tetanus and Diphtheria Toxoids Adsorbed (Td) in Adolescents and Adults 11 – 64 Years of AgeActive immunization against tetanus, diphtheria and pertussisMedDRA version: 18.1Level: PTClassification code 10054129Term: Diphtheria immunisationSystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 18.1Level: PTClassification code 10069577Term: Pertussis immunisationSystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 18.1Level: PTClassification code 10054131Term: Tetanus immunisationSystem Organ Class: 10042613 - Surgical and medical proceduresEUCTR2015-005845-30-Outside-EU/EEASanofi Pasteur Limited189
进行中（未招募）
不适用
Study of Tetanus and Diphtheria Toxoids Adsorbed Combined With Component Pertussis Vaccine and Inactivated PoliomyelitisPertussisTetanusDiphtheriaPoliomyelitisHepatitis BEUCTR2015-005196-24-Outside-EU/EEASanofi Pasteur Limited174
已完成
不适用
Ten year follow-up of subjects from 3 randomized controlled Bronchial Thermoplasty (BT) studies.10038716AstmaNL-OMON46716Boston Scientific Cooperation International7
进行中（未招募）
不适用
Immune Responses in Adults to Revaccination With ADACEL® 10 Years After a Previous DosePertussisTetanusDiphtheriaEUCTR2015-005197-38-Outside-EU/EEASanofi Pasteur Limited768