A Phase III Open-label Study to Evaluate the Immunogenicity and Safety of Typhoid Tetanus Toxoid Conjugate Vaccine, Typbar TCV® in Adults (greater than 65 Years).
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 4
- 主要终点
- 1. 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
A Phase III Open-label Study to Evaluate the Immunogenicity and Safety of Typhoid Tetanus Toxoid Conjugate Vaccine; Typbar TCV® in Adults (>65 Years)
A total of 300 healthy subjects of age group > 18 year will participate in this study in which approximately 150 subjects will be of age 18-65 years and 150 subjects will be >65 years.
On Day 0 (baseline) and Day 28 ±2, 5mL of blood will be collected for immunogenicity testing.
Primary objective
To evaluate the immunogenicity of Typbar TCV® through the measurement of seroconversion and geometric mean titers of anti-Vi IgG antibodies.
Secondary objective
To evaluate the Safety of Typbar TCV® in all age groups throughout the study period.
Immune responses will be assessed as GMTs and seroconversion rates (> fourfold rise). GMTs will be compared using a 2-sample Student t-test on log transformed
titers, and seroconversion rates will be compared using the Pearson χ2 test. Confidence intervals will be calculated from log-transformed titers, using t distribution for GMTs and by adjusted Wald method for seroconversion.
Chi-square test or fisher’s exact test will be used to calculate differences in categorical variables and proportion of adverse events reported. Significance will be set at p < 0.025 (1-sided) or p < 0.05 (2-sided).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects of age ≥18 without significant medical history or abnormal clinical findings
- •Subject who has been explained about all risks and benefits of the Trail and is willing to provide written informed consent.
- •Agrees to be available for all Trail related visits and procedures throughout the duration of the Trail.
- •Female subjects 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 clinical judgement of the Principal Investigator.
排除标准
- •Subjects who are under the age of 18 years
- •Fever of any origin or duration for more than 3 days prior to intended Trail immunization
- •History of Typhoid vaccination in the last 5 years
- •History of Typhoid disease in the last 5 years
- •History of any illness or any laboratory abnormality that, in the opinion of the investigator, might interfere with the results of the Trail or pose additional risk to the subjects due to participation in the Trail
- •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 immunodeficient 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 Trail protocol.
- •History of allergy or allergic reactions to vaccine or any vaccine component
- •Women who are pregnant or breast-feeding.
- •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 Trail participation or intent to participate in any other clinical trial during the conduct of the Trail.
结局指标
主要结局
1. 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±2.
2. Anti-Vi IgG GMT will be assessed on Day 0 and Day 28±2.
时间窗: Day 0 and Day 28±2.
次要结局
- 1. Occurrence of solicited local and systemic adverse events, unsolicited adverse events and proportion of subjects with Serious Adverse Events(1.30 minutes after vaccination)
研究者
Dr V Krishna Mohan
Bharat Biotech international limited