CTRI/2019/07/020451已完成3 期
A multicentre single arm non-comparative Phase-III study to evaluate the safety and tolerability of single intramuscular dose of Biological E’s Vi-capsular Polysaccharide-CRM197 Conjugate Typhoid Vaccine in =6 months old infants to 45 years old adults. - None
Biological ELimited0 个研究点目标入组 1,770 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,770
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. Healthy subjects of either gender between =6 months to =45 years of age at the time of vaccination
- •2. Subject or Subject’s Parent(s) or LAR who after the nature of the study has been explained to them, have given written consent according to local regulatory requirements.
- •3. Subject or Subject’s Parent(s) or LAR’s ability to understand information relevant to participation in the study and abide with the requirements of the subject diary and other study procedures;
- •4. Individuals in good health as determined by the outcome of medical history, physical examination based on clinical judgment of the investigator.
- •5. Negative to urine pregnancy test for female subjects of childbearing potential. Female of childbearing potential is defined as a pre-menopausal female capable of becoming pregnant. This does not include females who meet any of the following conditions: (1) menopause at least 2 years earlier, (2) tubal ligation at least 1 year earlier, or (3) total hysterectomy.
排除标准
- •1. Individuals who have previously received any vaccines against typhoid fever (either oral live attenuated or injectable vaccines);
- •2. Individuals with body temperature =100.4°F (=38.0°C) within 3 days of intended study immunization;
- •3. Individuals with any serious chronic or progressive disease according to judgment of the investigator (e.g., neurological, neoplasm, insulin dependent diabetes, cardiac, renal or hepatic disease);
- •4. Subject or Subject’s Parent(s) or LAR unwillingness or inability to understand and follow required study procedures, keep appointments, or are planning to relocate during the study period;
- •5. Individuals with history of any illness or any laboratory abnormality that, in the opinion of the investigator, which might pose additional risk to the subjects due to participation in the study;
- •6. Subject with a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time or history of receipt of anti-coagulants in the past 3 weeks;
- •7. History of allergy or allergic reaction to any vaccine-related component;
- •8. Individuals participated/participating in any other clinical trial within 30 days prior to first study visit or intent to participate in another clinical study at any time during the conduct of this study;
- •9. Women who are pregnant or breast-feeding or of childbearing age who have not used or do not plan to use acceptable birth control measures, for the duration of the study. Female of childbearing potential or age is defined as a pre-menopausal female capable of becoming pregnant. This does not include females who meet any of the following conditions: (1) menopause at least 2 years earlier, (2) tubal ligation at least 1 year earlier, or (3) total hysterectomy.
- •10. Any other reason that in the opinion/judgement of the investigator may interfere with the evaluation required by the study objectives.
研究者
相似试验
已完成
4 期
A post licensure clinical trial to assess the safety and tolerability of BE’s Measles-Rubella vaccine in 9 to 12 months old healthy infants in a single dose.CTRI/2019/04/018683Biological ELimited1,000
进行中（未招募）
1 期
Mifepristone 50mg as a weekly ContraceptivePrevention of unwanted pregnancyEUCTR2020-000866-41-Outside-EU/EEAWomen on Web International Foundation
已完成
3 期
A phase III clinical trial to assess efficacy and safety of YW17 (laronidase; CinnaGen)Patients with Mucopolysaccharidosis type I (MPS I).Mucopolysaccharidosis, type IE76.0IRCT20150303021315N30CinnaGen company12
进行中（未招募）
1 期
An international study of durvalumab in combination with platinum and etoposide for the treatment of small cell lung cancerExtensive-stage Small Cell Lung CancerEUCTR2020-005537-32-BGAstraZeneca AB150
进行中（未招募）
1 期
An international study of durvalumab in combination with platinum and etoposide for the treatment of small cell lung cancerMedDRA version: 21.1Level: PTClassification code 10041068Term: Small cell lung cancer extensive stageSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Extensive-stage Small Cell Lung CancerEUCTR2020-005537-32-CZAstraZeneca AB150