A Phase III, Multicenter, Double Blind, Randomized Study of SII Yellow Fever Vaccine to Compare Safety and Immunogenicity With STAMARIL® In Healthy Infants
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 2,216
- 试验地点
- 4
- 主要终点
- YF neutralizing antibody (NAb) seroconversion
研究概览
简要总结
The study is designed as a Phase III, double-blind, multi-center, randomized, active-controlled study in which four groups of participants (n=554 per group) will receive either one of three different manufacturing lots of SII-YFV or STAMARIL® - a licensed and WHO pre-qualified YFV.
详细描述
The study is designed as a Phase III, double-blind, multi-center, randomized, active-controlled study in which four groups of participants (n=554 per group) will receive either one of three different manufacturing lots of SII-YFV or STAMARIL® - a licensed and WHO pre-qualified YFV.
A single dose of either SII-YFV or STAMARIL® will be administered concomitantly with an MMR and a Men A vaccine. The study will start only after the approval from the applicable ethics committees and national regulatory agencies. Following parental / guardian consent, participants will be screened for eligibility based on the defined inclusion and exclusion criteria for the trial. There will be three scheduled visits during the study. A screening and vaccination visit (Day 0) followed by additional study visits on Day 28 and on Day 180 post-vaccination.
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)
入排标准
- 年龄范围
- 9 Months 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy infants as established by medical history and clinical examination
- •Male or female infants aged 9 to < 12 months (from the day they reach 9 months-of-age until the day before they reach 12-months/1-year-of-age)
- •Parental/ guardian ability and willingness to provide informed consent (as per local requirements/procedures), and to adhere to the protocol requirements.
- •Intend to remain residing in the study area throughout study participation
- •Parents/guardians willing to avoid the use of traditional/herbal local medications and treatments in infants for the duration of the study
排除标准
- •Fever (> 37.5°C) or any clinically significant acute infection at time of vaccination [Temporary exclusion criteria - participants may be rescreened at least 48 hours after the last recorded fever].
- •Previous history of laboratory confirmed infection with yellow fever, measles, mumps, rubella, Neisseria meningitidis serogroup A, and other flaviviruses e.g., dengue fever, tick-borne-encephalitis (TBE), Japanese encephalitis (JE), West Nile virus (WNV), zika virus, etc.
- •Previous vaccination against yellow fever, measles, mumps, rubella, Neisseria meningitidis serogroup A, TBE, JE, or dengue fever.
- •Receipt of any vaccine within past 28 days or planned vaccination until completion of day 28 study visit
- •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 immunoglobulin therapy and/or blood products since birth or planned administration until completion of Day 28 visit
- •Current or planned participation in another interventional study at any point throughout the entire study period
- •Receipt of any other investigational product or unlicensed medication in the preceding 28 days, or planned use until completion of Day 28 visit
- •Presence of significant malnutrition (weight-for-height z-score < -3SD)
结局指标
主要结局
YF neutralizing antibody (NAb) seroconversion
时间窗: Day 28 post-vaccination
Non-inferiority of the immune responses generated by SII-YFV compared to STAMARIL® in terms of YF neutralizing antibody (NAb) seroconversion rates as determined by plaque reduction neutralization test (PRNT50). Percentage seroconversion\* on Day 28 post-vaccination \* Seroconversion is defined as a four-fold rise in YF NAb (PRNT50) titres from baseline
次要结局
- Yellow Fever Vaccine GMTs(Day 0 pre-vaccination and Day 28 post-vaccination)