CTRI/2018/03/012558已完成1 期
An open label single arm phase-I study to evaluate safety, reactogenicity and immunogenicity of single intramuscular dose of Biological Eâ??s Vi-capsular Polysaccharide-CRM197 Conjugate Typhoid Vaccine in 18-45 year-old healthy adults. - None
Biological ELimited0 个研究点目标入组 30 人开始时间: 待定最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
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
入选标准
- •1.Adult male volunteers >=18 to <=45 years of age;
- •2.Signed voluntary informed consent obtained prior to screening from subject;
- •3.Individuals or their legally acceptable representative (LAR) who, after the nature of the study has been explained to them, have given written consent according to local regulatory requirements;
- •4.Subject or LARâ??s ability to understand information relevant to participation in the study and abide with the requirements of the subject diary and other study procedures;
- •5.Individuals in good health as determined by the outcome of medical history, physical examination, routine haematological and biochemistry blood tests and clinical judgment of the investigator.
排除标准
- •1.Individuals or LAR unwillingness or inability to understand and follow required study procedures, keep appointments, or is planning to relocate during the study period
- •2.Individuals who have previously received any vaccines against typhoid fever (either oral live attenuated or injectable vaccines)
- •3.Individuals who have had household contact with/and or intimate exposure to an individual with laboratory confirmed S. Typhi.
- •4.Individuals who have a previously ascertained or suspected disease caused by S. Typhi.
- •5.Individuals with any progressive or severe neurological disorder, seizure disorder or Guillain-Barré syndrome.
- •6.Individuals with history of any illness that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subjects due to participation in the study.
- •7.Individuals with known or suspected HIV infection or HIV related disease, with history of an autoimmune disorder or any other known or suspected impairment /alteration of the immune system, or under immunosuppressive therapy including use of systemic corticosteroids or chronic use of inhaled high-potency corticosteroids within the previous 30 days, or were in chemotherapy treatment within the past 6 months.
- •8.Individuals with a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
- •9.Individuals with any serious chronic or progressive disease according to judgment of the investigator (e.g., neoplasm, insulin dependent diabetes, cardiac, renal or hepatic disease).
- •10.Individuals who have any malignancy or lymphoproliferative disorder.
- •11.Individuals with history of allergy or allergic reaction to any vaccine-related components.
- •12.Individuals participating in any clinical trial with another investigational product 30 days prior to first study visit or intent to participate in another clinical study at any time during the conduct of this study.
- •13.Individuals who received any other vaccines within 4 weeks prior to enrolment in this study or who are planning to receive any vaccine within 4 weeks from the study vaccine .
- •14.Individuals who have received blood, blood products and/or plasma derivatives including parenteral immunoglobulin preparations in the past 12 weeks.
- •15.Individuals who are part of study personnel or close family members to the personnel conducting this study.
- •16.Individuals with body temperature >100.4°F ( >38.0°C) within 3 days of intended study immunization.
- •17.Individuals with history of substance or alcohol abuse within the past 2 years.
- •18.Any condition, which, in the opinion of the investigator may interfere with the evaluation of the study objectives.
研究者
相似试验
招募中
1 期
Clinical research of filling extraction sockets with selective COX2 inhibitor-containing paste in patients with mandibular wisdom tooth extractions.third molarwisdom tooth extractionD008964JPRN-jRCTs051230162Kakei Yasumasa12
已完成
1 期
Study to evaluate the amount of ketoprofen remaining in the mouth and its concentration in saliva after mouthwash rinse with OKI gola® 1.6% collutorio in healthy male and female volunteersPhase I study in healthy volunteers of both sexesISRCTN14847288Dompé farmaceutici S.p.A.36
撤回
1 期
Evaluation of the Safety and Efficacy of CMB-012 in Subjects with Chemical Burns of theCornea and/or Persistent Corneal Epithelial Defects (PCED)Persistent Corneal Epithelial DefectChemical BurnEye - Diseases / disorders of the eyeInjuries and Accidents - BurnsACTRN12619001724167Combangio, Inc.6
已完成
1 期
A phase-I clinical study to assess the safety of Biological Es Inactived Polio vaccine in 18-45 year old healthy male adults.CTRI/2019/04/018656Biological ELimited24
已完成
1 期
A phase-I clinical study to assess the safety of Biological Es Inactived Polio vaccine in 18-45 yearold healthy male adults.CTRI/2019/04/018474Biological ELimited24