A Phase 2/3 Multicenter, Double blind, Randomized Study of SII Yellow Fever Vaccine to Compare Safety and Immunogenicity with STAMARIL in Adults
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 580
- 试验地点
- 5
- 主要终点
- To demonstrate the non-inferiority between the SII-Yellow Fever vaccine and Stamaril with respect to seroconversion rates (four fold rise to baseline PRNT50 titres) post-vaccination
研究概览
简要总结
The study is designed as a multi center, double-blind, randomized clinical study to compare safety and immunogenicity of SII yellow fever vaccine with STAMARIL in healthy adults.
The participants will be screened after informed consent and those eligible will be enrolled.
A total of 580 participants will be randomized to the two groups in a ratio of 1:1 and will receive either a single dose of SII Yellow Fever Vaccine or STAMARIL via subcutaneous route.
During the entire study, a participant will have three scheduled visits – Screening, Vaccine administration on Day 0, and post-vaccination visits on Day 28 (+14), 180 (+28).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or female volunteers aged ≥ 18 years
- •Healthy volunteers as determined by medical history and clinical examination
- •Participants willing to adhere to the protocol requirements and to provide informed consent.
- •Intend to remain residing in study area throughout study participation
- •Female participants of childbearing potential having a negative pregnancy test within 24 hours prior to IP administration and agreeing to practice.
排除标准
- •Fever Axillary Temperature more than 37.5 C or any clinically significant acute infection at time of vaccination Temporary exclusion criteria participants may be reassessed for eligibility at least 48 hours after the last recorded fever
- •Previous history of infection with yellow fever, and other flaviviruses dengue fever, tick-borne-encephalitis, Japanese encephalitis, West Nile virus, zika virus, etc.
- •Previous vaccination against yellow fever, TBE, JE, or dengue fever.
- •A known hypersensitivity to any of the vaccine components (including gelatin, eggs, egg products, or chicken protein) or history of a life-threatening reaction to any past vaccine.
- •Receipt of any immunoglobulin therapy and or blood products in the past 60 days or planned administration until completion of Day 28 visit.
- •Participation in a drug research study, involving investigational products, within past 3 months or planned participation during the entire study period.
- •Receipt of any investigational or unlicensed medication (drug or vaccine) in the preceding 28 days, or planned use until completion of Day 28 visit
- •Pregnant or lactating women
- •Requirement of Yellow Fever vaccination certificate for travelling purpose
- •Major congenital or genetic defect.
结局指标
主要结局
To demonstrate the non-inferiority between the SII-Yellow Fever vaccine and Stamaril with respect to seroconversion rates (four fold rise to baseline PRNT50 titres) post-vaccination
时间窗: PRNT50 titres will be measured at baseline pre-vaccination and post-vaccination at Day 28
次要结局
- safety, solicited and unsolicited events(solicited till day 10 post vaccination and unsolicited day 28 post vaccination and SAE till day 180 post vaccination)
研究者
Dr Prasad Kulkarni
Serum Institute of India Pvt Ltd