CTRI/2023/02/049637已完成2 期
A prospective, randomized, two-arm, parallel, placebo-controlled, multicentre, superiority,phase II clinical trial to evaluate the immunogenicity and safety of Recombinant Hepatitis E Vaccine (Adsorbed) of M/s. Zydus Lifesciences Limited in healthy subjects
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 304
- 试验地点
- 6
- 主要终点
- Proportion of subjects with seroconversion for anti-HEV IgG antibodies
研究概览
简要总结
This will be a randomized, two-arm, single-blind, parallel, placebo-controlled, multicentre clinical study planned to evaluate the immunogenicity and safety of the hepatitis E vaccine administered to healthy subjects of 16 to 65 years of age. Hepatitis B vaccine of M/s. Serum Institute of India Pvt. Ltd. which is marketed in the country for past several decades and recommended for administration through the same 3-dose schedule will be used as placebo in this study. The randomized subjects will be enrolled in either study group as per their randomization number and will be followed up in a parallel manner till the completion of the study.
Immunogenicity will be evaluated at day 0 (pre-vaccination), day 30, day 60, day 180 and day 210. Safety will be evaluated by recording the adverse events occurring during the course of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 16.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy subjects of either gender between 16 to 65 years of age (both inclusive) at the time of enrollment
- •Subjects should be in a good health as determined by the medical history and physical examination based on clinical judgment of the investigator
- •No previous history of vaccination with any licensed or investigational Hepatitis E Vaccine
- •Informed consent from the adult subjects or from the parents of adolescent subjects (<18 years).
- •Additionally, assent from adolescent subjects
- •Adult subjects or parents of adolescent subjects literate enough to fill the diary card
- •Adult subjects or adolescent subjects and parents likely to be available for follow-up for entire duration of the study.
排除标准
- •History of hypersensitivity reaction or serious adverse event to any component of the vaccine
- •History of laboratory confirmed or suspected hepatitis / jaundice in the past
- •Fever of any origin or infectious disorder of 3 days or more within past one month
- •History of vaccination against Hepatitis B within past 10 years
- •Subjects with febrile illness (body temperature ≥37.5°C) at the time of enrollment
- •History of any vaccination within past one month
- •Clinically significant systemic disorder such as cardiovascular, respiratory, neurologic, gastrointestinal, hepatic, renal, endocrine, hematological or immunological disorder
- •Any confirmed or suspected immunosuppressive or immunodeficiency disorder (based on medical history); or subjects who have used any immunosuppressive or immunostimulant therapy in past 1 month
- •Known case of thrombocytopenia or any coagulation disorder, or subjects on anticoagulation therapy
- •Subjects administered blood, blood containing products or immunoglobulins within the last 3 months or planned administration during the study
- •Pregnant and lactating women & female subjects not using acceptable contraceptive measures (double barrier methods, oral or injectable hormonal contraceptives or surgical sterilization)
- •Subject participated in another clinical study in the past 3 months or subject intends to participate in another clinical study during the study period
- •Subject with history of alcohol or drug abuse in the past one year
- •Any other reason for which the investigator feels that subject should not participate.
结局指标
主要结局
Proportion of subjects with seroconversion for anti-HEV IgG antibodies
时间窗: At Day 210 (End of the study)
次要结局
- Local and systemic adverse events reported(Throughout the study duration)
- Serious adverse events reported(Throughout the study duration)
- Proportion of subjects with seroconversion for anti-HEV IgG antibodies(At Day 30 and Day 60)
- Geometric mean titre of anti-HEV IgG antibodies(At Day 0, Day 30, Day 60 and Day 210)
研究者
研究点 (6)
Loading locations...
相似试验
终止
3 期
Evaluation of BE1116 in Patients With Traumatic Injury and Acute Major Bleeding to Improve Survival ( TAP Study )Traumatic InjuryNCT05568888CSL Behring1,366
已完成
2 期
An Evaluation of the Efficacy and Safety of TOLAMBA™ for Ragweed-Allergic Rhinitis in an Environmental Exposure ChamberRhinitis, Allergic, SeasonalNCT00537355Dynavax Technologies Corporation271
已完成
2 期
Phase II Clinical Study to Evaluate Safety and Efficacy of Azelastine 0.1% Nasal Spray in Non-hospitalized Patients with Mild COVID-19 InfectionCTRI/2022/09/045465Ursapharm Arzneimittel GmbH290
招募中
不适用
A Clinical Study on the Efficacy and Safety of Xuanfei Baidu Granule in the Treatment of Acute Exacerbation of Chronic Obstructive Pulmonary DiseaseAcute Exacerbation of Chronic Obstructive Pulmonary DiseaseNCT06134063Peking University People's Hospital375
进行中（未招募）
3 期
A Study with perampanel as a treatment in children and adults with Lennox-Gastaut syndrome who have poorly controlled seizures.CTRI/2020/10/028718Eisai Ltd142