TCTR20190927006已完成3 期
A phase III randomized, observer-blind, active-controlled study to compare the safety and immunogenicity of an investigational combined Tetanus-diphtheria-recombinant acellular pertussis vaccine (BioNet Tdap) and licensed recombinant TdaP vaccine (Boostagen), investigational recombinant monovalent acellular pertussis vaccine (BioNet ap) and licensed recombinant aP vaccine (Pertagen), and another licensed Tdap vaccine, when administered to healthy adults aged of 18-75 years old
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 734
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 Years 至 75 Years（—）
- 性别
- All
入选标准
- •1. Aged 18 to 64 years (less than 65 years full of age) or 65 to 75 years (less than 76 years full of age) on the day of inclusion;
- •2. Can provide written informed consent;
- •3. Healthy, as established by pertinent medical history and physical examination;
- •4. Capable of complying with the study protocol and procedures;
- •5. For women who have not had menopause, must have a negative urine pregnancy test at enrollment and willing to take reliable birth control measures for two months after vaccination.
排除标准
- •1. History of significant medical illness such as but not limited to immune deficiency, clinically significant psychiatric, hematologic, pulmonary, cardiovascular, or hepatic, renal, splenic or thymic functional abnormality as determined by the investigator based on medical history and physical examination that may interfere with the participations safety and the evaluation of investigational vaccines in this study;
- •2. Breastfeeding women or female participants who intend to become pregnant during the study period;
- •3. History of a severe allergic reaction to any vaccine (including its components);
- •4. History of serious adverse event or neurological adverse event to any vaccination;
- •5. Receipt of any investigational product or licensed vaccine within 30 days prior to enrollment (3 months for live-attenuated vaccines);
- •6. Plan to receive tetanus, diphtheria or pertussis vaccine or plan to participate in other clinical trial during the study period (approximately one year);
- •7. Having been experienced physician-diagnosed pertussis within 1 year prior to enrollment;
- •8. Receipt of diphtheria or tetanus or pertussis vaccine within 1 year prior to enrollment;
- •9. Any chronic or active neurologic disorder, including seizure, and epilepsy;
- •10. Has a known history of Guillain-Barr Syndrome;
- •11. Has an active malignancy or recent (<10 years) history of metastatic or hematologic malignancy;
- •12. Any bleeding disorder indicated;
- •13. Suspected or known alcoholism and/or illicit drug abuse within the past 5 years;
- •14. Administration of immunoglobulins and/or any blood products within 3 months preceding study entry or planned administration during the study period;
- •15. History of receiving immunosuppressive drugs or systemic corticosteroid (>0.5 mg/kg of prednisolone or equivalent for more than 14 days) within 3 months prior to study entry;
- •16. Has any active clinically significant finding or life-threatening disease that, in the opinion of the investigator, would increase the risk of the individual having an adverse outcome by participating in this study.
研究者
相似试验
尚未招募
2 期
CVIA 106 - Phase 2/3 study of the EuBiologics pentavalent meningococcal ACWYX conjugate vaccine compared to MENVEO® or Nimenrix ® in healthy children through adultsNervous System DiseasesPACTR202407771418605Eubiologics Co Ltd4,236
已完成
不适用
PsA-TT-006MeningitisNervous System DiseasesPACTR2010030001913177PATH6,000
进行中（未招募）
2 期
A trial to evaluate the ability to provoke an immune response and the safety of mRNA-1273.529 (Omicron Variant) in comparison with mRNA-1273 (prototype) booster vaccineISRCTN99890480ModernaTX, Inc. (USA)2,924
进行中（未招募）
1 期
A Study to Evaluate the Immunogenicity and Safety of Omicron Variant Vaccines in Comparison With mRNA-1273 Booster Vaccine for COVID-19SARS-CoV-2EUCTR2022-000063-51-Outside-EU/EEAModernaTX, Inc.
Unknown
3 期
Study to Assess Immunegnicity & Safety of Pentavalent Meningococcal Vaccine (NmCV-5)Meningococcal MeningitisPACTR201908558841221Serum Institute of India Pvt. Ltd.1,800