A Phase IV Study to Evaluate the Immunogenicity and Safety of Purified Vi capsular polysaccharide (of Salmonella typhi, Ty2 strain) tetanus toxoid conjugate vaccine; Typbar-TCV® in Adults
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 5
- 主要终点
- Proportion of subjects attaining seroconversion ( four-fold rise in anti-salmonella typhi Vi polysaccharide IgG antibody titre compared to baseline), 28±2 days after vaccine administration
研究概览
简要总结
Open-labelled study to evaluate theimmunogenicity and safety of Typhoid Conjugate vaccine (Typbar TCV®) in adults within the age group of ≥18 to≤65 years.
Visit 1:(Day 0+3days)--Subjects between ages≥18 to ≤65 years will be screened as per theeligibilty criteria, after obtaining written informed consent.5 mL of peripheral venous blood will becollected before vaccination for the baseline antibody titer estimation at Day0 (Visit 1). One dose of 0.5ml of BBIL’s Typbar TCV® will beadministered in the deltoid region of the arm. Subjects will be observed for 30minutes after vaccine administration for vaccine reactogenicity. If no adverseevent is observed subject is allowed to leave the site.
Visit 2: (Day 28±2)
Onday 28±2, the following activities will be recorded: current health status,physical examination, vital signs and body temperature. 5 mL of blood samplewill be collected for immunogenicity testing. Dairy card will be collected andreviewed.
Follow-up (3 months)
Telephonic follow-up will be done once at theend of 3 months from the day of vaccination to record the adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects of age ≥18 to ≤65years (inclusive) without significant medical history or abnormal clinical findings Subject or Subject’s Legally Acceptable Representative (LAR) who has been explained about all risks and benefits of the study and is willing to provide written informed consent Agree to be available for all study related visits and procedures throughout the entire duration of the study.
- •Female subject’s of child bearing potential must demonstrate a negative urine pregnancy test at the time of screening.
- •Individuals who are in good health as determined by the outcome of medical history, physical examination and based on the clinical judgement of the Principal Investigator.
排除标准
- •Subjects with age less than 18 years and more than 65 years.
- •Fever of any origin or duration for more than 3 days prior to intended study immunization Past history of Typhoid infection.
- •History of any illness or any laboratory abnormality 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 Individuals with any serious chronic or progressive diseases according to the judgment of Investigator (eg: neurological, neoplasm, insulin-dependent diabetes, hepatic, renal, cardiac diseases).
- •Any confirmed or suspected use of immunosuppressive drugs or Immuno deficient condition.
- •Use of any marketed/investigational/herbal medicine or non-registered drug or vaccine for Typhoid.
- •Any criteria, which in the opinion of the investigator, suggests that the subject may not be compliant with the study protocol.
- •History of allergy or allergic reactions to the vaccine or any vaccine component.
- •Women who are pregnant or breast-feeding or of childbearing age.
- •Married or sexually active participants who are not willing to follow effective birth control methods for at least 3 months after vaccine.
- •Individuals participating in any other clinical trial within one month prior to study participation or intent to participate in any other clinical trial during the conduct of the study.
结局指标
主要结局
Proportion of subjects attaining seroconversion ( four-fold rise in anti-salmonella typhi Vi polysaccharide IgG antibody titre compared to baseline), 28±2 days after vaccine administration
时间窗: Day 0 and Day 28
Compare GMT and Seroconversion at Day 0 and Day 28
时间窗: Day 0 and Day 28
次要结局
- Occurrence of solicited local and systemic adverse events, unsolicited adverse events and proportion of subjects with Serious Adverse Events(Day 0 and Day 28)