NCT01437267已完成2 期
A Phase 2, Randomized, Controlled, Observer Blind, Single Center Study of the Safety, Reactogenicity and Immunogenicity of the NVGH Glycoconjugate Vaccine Against S. Typhi in Children, Older Infants and Infants
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Percentage of Subjects With at Least 4-fold Increase in Anti-Vi ELISA Titer
研究概览
简要总结
This phase 2 trial is aimed to obtain information on the safety and immunogenicity of the Vi-CRM197 in children and infants from various age groups in the Philippines where Typhoid Fever is highly endemic and an efficacious vaccine against this disease is very much needed.
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
- 6 Weeks 至 59 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects belonging to 3 age groups will be enrolled into the trial: children (24 to 59 months of age at enrollment), older infants (9 to 12 months of age at enrollment) and infants (6 weeks of age at enrolment).
- •Written informed consent will be obtained by the parents/ guardians before enrollment into the trial.
- •Infants who have been vaccinated with BCG and HBV at birth and OPV at any time since birth can be enrolled into the trial, while infants who have received DTwP+HBV+Hib due at 6 weeks of age as per local EPI schedule cannot be enrolled into the trial.
排除标准
- 未提供
结局指标
主要结局
Percentage of Subjects With at Least 4-fold Increase in Anti-Vi ELISA Titer
时间窗: At 6 months after last vaccination as compared to baseline
Percentage of Subjects With at Least 4-fold Increase in Anti-Vi Enzyme-linked Immunosorbent Assay (ELISA) Titer
时间窗: At 28 days after last vaccination as compared to baseline
Anti-Vi ELISA Geometric Mean Concentration (GMC)
时间窗: At 28 days after last vaccination
Anti-Vi ELISA GMC
时间窗: At 6 months after last vaccination
次要结局
- Number of Participants With Any Solicited Local and Systemic Reaction, After Any Vaccination(During the 7-day follow-up period after vaccination)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
2 期
Safety and Immunogenicity of Vi-CRM197 Vaccine Against S. Typhi in Adults, Children, Older Infants and InfantsTyphoid FeverNCT01229176Novartis200
进行中（未招募）
2 期
Safety and Immunogenicity of CRV-101 Vaccine for the Prevention of Herpes Zoster in Adults Aged 50 Years and OlderShinglesHerpes ZosterNCT05304351Curevo Inc1,516
已完成
1 期
Safety and Immunogenicity of Vi-CRM197 Vaccine Against S. Typhi in Adult (18-40 Years Old)Typhoid FeverNCT01123941Novartis50
已完成
1 期
Study of Varying Injection Schedules of TDENV-PIV Vaccine With AS03B Adjuvant and Placebo in Healthy US AdultsDengueNCT02421367U.S. Army Medical Research and Development Command140
撤回
2 期
Immunogenicity and Safety of Adjuvanted SCB-2020S Vaccines in AdultsCOVID-19NCT04950751Clover Biopharmaceuticals AUS Pty