A Phase 2/3, Double-Blind, Randomized, Active-Controlled, Multicentric study to evaluate the Safety, Immunogenicity and Lot-to-Lot consistency of a bivalent conjugate vaccine against Salmonella enterica serovars Typhi and Paratyphi A in healthy individuals aged 6 months to 65 years
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 2,729
- 试验地点
- 16
- 主要终点
- 1.Immediate adverse events within 30 minutes post-vaccination.
研究概览
简要总结
A Phase 2/3, Double-Blind, Randomized, Active-Controlled, Multicentric study to evaluate the Safety, Immunogenicity and Lot-to-Lot consistency of a bivalent conjugate vaccine against Salmonella enterica serovars Typhi and Paratyphi A in healthy individuals aged 6 months to 65 years. The Study will be conducted in 2 phases. Phase 2 will be conducted in 18 to 65 years age group, 150 participants. In Phase 3 Healthy male or female participants aged 6 months to 65 years will be divided into four age groups: 6 months to <2 years, 2 to < 10 years, 10 to < 18 years and 18 to 65 years. The study will have two groups SII-TCV (B) and Typbar-TCV given to participants randomized in 2:1 ratio. Either SII-TCV(B) or Typbar-TCV will be administered as single dose of 05.mL via intramuscular route to the participants. The participants will be followed up until 180 days after the vaccination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 6.00 Month(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or female participants aged between more than 6 months to less than 65 years
- •Normal health as determined by medical history and clinical examination.
- •Intend to remain residing near study area throughout study participation.
- •Female participants of childbearing potential with negative pregnancy test prior to IP administration.
排除标准
- •History of S.
- •Typhi or S.
- •Paratyphi A infection.
- •Previous vaccination for typhoid fever
- •Planning to receive any vaccine until Day 29 post-vaccination.
- •Major congenital or genetic defect
- •Pregnant or lactating women
- •History or presence of significant alcoholism or drug abuse in the past one year.
结局指标
主要结局
1.Immediate adverse events within 30 minutes post-vaccination.
时间窗: 1. 30 minutes post-vaccination | 2. Day 7 post-vaccination
2.Solicited local and systemic adverse events up to Day 7 post-vaccination
时间窗: 1. 30 minutes post-vaccination | 2. Day 7 post-vaccination
次要结局
- To compare the safety(and tolerability of SII-TCV()