TCTR20180321004已完成2 期
A phase II randomized controlled trial evaluating the immunogenicity and safety of a recombinant aP vaccine and various Tdap vaccine formulations in healthy women of child bearing age
BioNet-Asia Co.,Ltd.0 个研究点目标入组 250 人开始时间: 2018年3月21日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 250
研究概览
简要总结
From July 5 to 22, 2018, 250 women with median age of 31 years were enrolled in the study. Seroresponse rates for anti-PT were 92% (95% CI 80.8-97.8) for BioNet ap, 88% (95% CI 75.7-95.5) for BioNet Tdap (low dose), 80% (95% CI 66.3-90.0) for BioNet Tdap (medium dose), 94% (95% CI 83.5-98.8) for Boostagen and 78% (95% CI 64.0-88.5) for Boostrix. All formulations passed the seroresponse criterion and will be further evaluated in pregnant women.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 Years 至 40 Years（—）
- 性别
- Female
入选标准
- •1. Female, aged 18-40 years (inclusive) at the time of enrollment;
- •2. Willing and able to provide written informed consent prior to any study procedure;
- •3. Free of clinically significant health problems, as determined by pertinent medical history and clinical examination at study screening;
- •4. Must have a negative urine pregnancy test at enrollment and willing to take reliable birth control measures for 1 month after vaccination;
- •5. Able to attend all scheduled visits and to understand and comply with the study procedures in the principal investigator's judgment.
排除标准
- •1. Acute or chronic, clinically significant psychiatric, hematologic, pulmonary, cardiovascular, or hepatic or renal functional abnormality as determined by the Investigator based on medical history, physical exam;
- •2. Pregnant or breast-feeding women or female who intends to become pregnant during the study period;
- •3. History of severe local or systemic reactions to any vaccination or a history of severe allergic reactions;
- •4. Known hypersensitivity or allergy to diphtheria, tetanus, or pertussis vaccine (including excipients);
- •5. Receipt of investigational product up to 30 days prior to enrollment or ongoing participation in another interventional clinical trial;
- •6. Receipt of licensed vaccines within 30 days prior to enrollment (3 months for live attenuated vaccines) or plan to receive other vaccine during the study period;
- •7. Receipt of diphtheria or tetanus or pertussis vaccine within 1 year prior to enrollment;
- •8. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination;
- •9. Any chronic or active neurologic disorder, including seizures, and epilepsy;
- •10. Has a known history of Guillain-Barre Syndrome;
- •11. Has an active malignancy or recent (<10 years) history of metastatic or hematologic malignancy;
- •12. Suspected or known alcohol and/or illicit drug abuse within the past 5 years;
- •13. Administration of immunoglobulins and/or any blood products within 3 months preceding study entry or planned administration during the study period;
- •14. 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;
- •15. Has any active clinically significant finding or life-threatening disease that, in the opinion of the investigator, would increase the risk of the individual's having an adverse outcome by participating in this study.
研究者
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