A Clinical Trial in Healthy Infants to Assess Lot-to-lot Consistency of Japanese Encephalitis Live Attenuated SA 14-14-2 Vaccine and Non-inferiority With Respect to an Earlier Product.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 818
- 试验地点
- 1
- 主要终点
- Number/Percentage of Subjects With Demonstrated Seroprotection
研究概览
简要总结
The proposed study is a four-arm double-blind randomized controlled single center trial to evaluate, by examining post-vaccination seroprotection titers, the lot-to-lot consistency of three lots of Japanese Encephalitis live attenuated SA 14-14-2 vaccine (LJEVac) manufactured in a new good manufacture practice (GMP) facility, and to establish non-inferiority of the new vaccine in comparison to a single lot of the same vaccine manufactured in the existing facility. The study aimed to enroll a total of 1,000 Bangladeshi infants aged 10 to 12 months. In addition to providing immunogenicity data, this study provided local safety data of JE live attenuated SA 14-14-2 vaccine among Bangladeshi children. This is the first step to secure licensure for this life-saving vaccine in Bangladesh as well as provide data to support WHO prequalification of JE live attenuated SA 14-14-2 vaccine.
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
- 10 Months 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Infant's parent(s) or legal guardian(s) willing to provide signed informed consent.
- •Healthy infants aged 10 to 12 months at enrolment residing in Matlab Health and Demographic Surveillance System (HDSS) intervention area who have completed all doses of Expanded Programme on Immunization (EPI) immunizations at least 4 weeks prior to enrolment: Bacillus Calmette-Guerin vaccine (BCG), Diphtheria-pertussis-tetanus vaccine (DPT), Hepatitis B (HBV), Haemophilus influenzae type (Hib), oral polio vaccine (OPV) and measles
排除标准
- •Acute medical illness with or without fever within the last 72 hours or an axillary temperature (≥ 37.5°C ) at the time of vaccination.
- •Use of antibiotics or antipyretics within the last 72 hours prior to enrolment.
- •Severely or moderately malnourished infants (<-3 Z score).
- •History of prematurity (< 36 weeks of pregnancy).
- •Underlying medical condition such as failure to thrive, inborn errors of metabolism, bronchopulmonary dysplasia, or any major congenital abnormalities requiring surgery or chronic treatment.
- •History of serious chronic disease (e.g., cardiac, renal, neurologic, metabolic, rheumatologic, hematologic, or bleeding disorder).
- •Known or suspected impairment of immunologic function.
- •History of documented or suspected encephalitis or meningitis.
- •History of seizures, including history of febrile seizures, or any other neurologic disorder.
- •History of JE infection.
- •Prior receipt of a JE vaccine.
- •Received measles vaccine within 4 weeks prior to, or scheduled to receive a vaccination during, the conduct of this trial.
- •Prior or anticipated receipt of immune globulin or other blood products, or injected or oral corticosteroids or other immune modulator therapy within 6 weeks of administration of the study vaccine.
- •Serious adverse reactions (e.g. urticaria, angioedema, shock, breathlessness following vaccination or any life threatening condition) with any previous EPI vaccine.
- •Unable to attend the scheduled visits or comply with the study procedures.
- •Enrolled in another clinical trial involving any therapy.
- •Any condition that in the opinion of the investigator, would pose a health risk to the child, or interfere with the evaluation of the study objectives.
研究组 & 干预措施
Reference Lot
Lot of Vaccine produced in existing facility
干预措施: Vaccine produced in existing facility (Biological)
New Lot #1
First lot of vaccine produced in new facility
干预措施: Vaccine produced in new facility (Biological)
New Lot #2
Second lot of vaccine produced in new facility
干预措施: Vaccine produced in new facility (Biological)
New Lot #3
Third lot of vaccine produced in new facility
干预措施: Vaccine produced in new facility (Biological)
结局指标
主要结局
Number/Percentage of Subjects With Demonstrated Seroprotection
时间窗: 28 days post-vaccination
Seroprotection was defined as a serum antibody titer equal to or greater than 1:10, as measured by Plaque reduction neutralization test (PRNT). The end point for neutralization was the highest dilution of serum reducing the number of plaques by 50%, compared with a negative serum control. In 2004, a group of experts under the leadership of the WHO recommended that seroprotection (SP) against JEV be defined as a neutralizing anti-JEV antibody serum titer ≥1:10 as determined by PRNT \[Hombach et al. 2005\]. Accordingly, a titer of ≥1:10 was adopted as an indicator of seroprotection in this study.
Geometric Mean Titers (GMT)
时间窗: 28 days post-vaccination
Geometric Mean Titers of Neutralizing anti-JEV antibody
次要结局
- Number/Percentage of Subjects With an Immediate Solicited Local or Systemic Reactogenicity Event (RE)(Within 30 minutes of vaccination)
- Number/Percentage of Subjects With a Solicited Local or Systemic Reactogenicity Event Within 7 Days After Vaccination(Within 7 days of vaccination)
- Number/Percentage of Subjects With Other Adverse Events (AE) During the Study(Between 7 and 28 days of vaccination)