A Phase III Multicenter, Observer-Blinded, Randomized, Active Controlled, Immune Non-inferiority and Safety Study of Vi-DT Vaccine Compared to Typbar TCV® in Healthy 6 Months-45 Years Aged Nepalese Participants.
试验速览
- 阶段
- 3 期
- 入组人数
- 1,800
- 试验地点
- 5
- 主要终点
- Seroconversion rate1
研究概览
简要总结
This is a Multicenter, observer-blinded, randomized, Active controlled, Phase 3 study in healthy 6 months to 45 years aged Nepalese at the time of the first vaccine dose.
The study objectives are:
I. Demonstrate non-inferiority of Vi-DT compared to Typbar TCV® as measured by seroconversion rates of anti-Vi IgG ELISA antibody titers, 4 weeks after single dose (pooled immunogenicity of three lots of Vi-DT)
II. Demonstrate the equivalence of immunogenicity as measured by anti-Vi IgG GMT of three lots of Vi-DT vaccine 4 weeks after single dose.
详细描述
Subjects will be stratified according to age. The study procedure is as follows:
Visit 1 (day-1 to -7): Screen participants by medical/medications history, physical examination, Vital signs, Urine pregnancy test (UPT)
Visit 2 (day 0): Enroll, randomize and administer vaccine to eligible participants and assess participant safety by physical examination and Vital signs, Collect blood for immunogenicity assessments.
Visit 3 (day 7): Check solicited adverse reaction 7 days post vaccination and Assess participant safety by physical examination and Vital signs
Visit 4 (day 28): Assess participant safety by physical examination and Vital signs, Collect blood for immunogenicity assessments
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
This study is observer blind:
- Vaccine administrator and vaccine safety evaluator at site will be two distinct persons.
- Laboratory personnel who analyzes immunogenicity at sponsor is also blinded.
入排标准
- 年龄范围
- 6 Months 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy participants 6 months to 45 years of age at enrollment
- •Participants/Parents/LAR who have voluntarily given informed consent/assent
- •Participants/Parents/LAR willing to follow the study procedures of the study and available for the entire duration of the study
排除标准
- •Child with a congenital abnormality
- •Subject concomitantly enrolled or scheduled to be enrolled in another trial
- •Known history of immune function disorders including immunodeficiency diseases (Known HIV infection or other immune function disorders)
- •Chronic use of systemic steroids (>2 mg/kg/day or >20 mg/day prednisone equivalent for periods exceeding 10 days), cytotoxic or other immunosuppressive drugs
- •Receipt of blood or blood-derived products in the past 3 months
- •Subject with a previously ascertained or suspected disease caused by S. Typhi
- •Subject who have had household contact with/and or intimate exposure to an individual with laboratory-confirmed S. Typhi
- •Individual who has previously received a typhoid vaccine
- •Subject who has received or is expected to receive other vaccines from 1 month prior to IP vaccination to Visit 4 (approx.1 month post IP) except PVC booster as per EPI schedule
- •Known history or allergy to vaccines or other medications
- •History of uncontrolled coagulopathy or blood disorders
- •Any abnormality or chronic disease which in the opinion of the investigator might be detrimental for the safety of the subject and interfere with the assessment of the study objectives
- •Any female participant who is lactating, pregnant* or planning for pregnancy during the course of study period
- •Participants/Parents/LAR planning to move from the study area before the end of study period
- •As per Investigator's medical judgement individuals could be excluded from the study inspite of meeting all inclusion/exclusion criteria mentioned above
- •Temporary Contraindication
- •Acute illness, in particular infectious disease or fever (axillary temperature ≥37.5°C), within three days prior to enrolment and vaccination.
- •Urine pregnancy test (UPT) will be performed in all married females prior to injection
结局指标
主要结局
Seroconversion rate1
时间窗: 4 weeks (28 days) after vaccination of Vi-DT(pooled)/ Typbar TCV® compared to baseline (D0)
Defined as a 4-fold increase of serum anti-Vi IgG antibody titer
Geometric Mean Titers (GMT)1
时间窗: 4 weeks after vaccination of Vi-DT
Measurement of the Geometric Mean Titers (GMT) following 4 weeks after vaccination of three lots of Vi-DT
次要结局
- Geometric Mean Titers (GMT) 2(4 weeks and 24 weeks after vaccination of Vi-DT(pooled)/ Typbar TCV®)
- Seroconversion rate 2(24 weeks (168 days) after vaccination of Vi-DT(pooled)/ Typbar TCV® compared to baseline (D0).)
- Seroconversion rate 3(4 weeks (28 days) after vaccination of Vi-DT(pooled))
- Seroconversion rate 4(4 weeks (28 days) after vaccination of Vi-DT(pooled))
- Seroconversion rate 5(4 weeks (28 days) after vaccination of MR compared to baseline (D0))
- Safety endpoints for solicited adverse events (reactogenicity)(7days after vaccination of Vi-DT(pooled)/ Typbar TCV®)