NCT01396512已完成3 期
Immunogenicity and Safety of a Single Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV™) in Comparison With a Single Dose of SA14-14-2 Vaccine (CD.JEVAX™, Chengdu Institute of Biological Products, China) Administered in Healthy Toddlers in South-Korea
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 274
- 试验地点
- 6
- 主要终点
- Percentage of Participants With Seroconversion to Japanese Encephalitis Chimeric Virus Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine
研究概览
简要总结
The purpose of this study is to compare Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV™) with Japanese encephalitis live attenuated vaccine (SA14 14 2 vaccine [CD.JEVAX™]) after a single dose vaccination to support product registration.
Primary Objective:
- To demonstrate the non-inferiority of the antibody response 28 days after administration of one dose of IMOJEV™ compared to the antibody response 28 days after administration of one dose of the CD.JEVAX™ control vaccine.
Secondary Objectives:
- To describe the immune response to Japanese encephalitis (JE) in both vaccine groups using 50% plaque reduction neutralization assay (PRNT50) assays before and after a single dose of IMOJEV™ vaccine or a single dose of CD.JEVAX™ vaccine.
- To describe the safety of vaccination in all subjects up to 28 days and all serious adverse events up to 6-month after vaccination.
详细描述
All participants will receive a single dose of their assigned vaccination at Visit 1 (Day 0) and undergo immunogenicity assessment at Day 28 post-vaccination. Safety will be assessed from day of vaccination and up to 6 months 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
- 12 Months 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 12 to 24 months on the day of inclusion
- •In good general health, without significant medical history.
- •Provision of informed consent form signed by at least one parent or other legally acceptable representative.
- •Subject and parent/guardian able to attend all scheduled visits and comply with all trial procedures.
排除标准
- •Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the trial vaccination.
- •Planned participation in another clinical trial during the present trial period.
- •Known or suspected congenital or acquired immunodeficiency, or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy.
- •Known systemic hypersensitivity to any of IMOJEV™ components or history of a life-threatening reaction to a vaccine containing any of the same substances and vaccination,known systemic hypersensitivity to CD.JEVAX® main components and the other components (including Gelatin, kanamycin, and gentamicin).
- •Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator.
- •Receipt of blood or blood-derived products in the past 3 months, that might interfere with the assessment of the immune response.
- •Previous vaccination against flavivirus disease, including Japanese encephalitis (JE).
- •Administration of any anti-viral within 2 months preceding Visit 01 and up to the 4 weeks following the trial vaccination.
- •Receipt of any vaccine in the 4 weeks preceding the first trial vaccination, except for pandemic influenza vaccination, which may be received at least two weeks before the study vaccines.
- •Planned receipt of any vaccine from the inclusion up to the 4 weeks following the trial vaccination.
- •History of central nervous system disorder or disease, including seizures.
- •Planned receipt of any JE vaccine during the course of the study.
- •History of flavivirus infection (confirmed either clinically, serologically or virologically).
- •Administration of systemic corticosteroids for more than two consecutive weeks within the 4 weeks preceding vaccination.
- •Febrile illness (temperature ≥38.0°C) or moderate or severe acute illness/infection 3 days before vaccination as well as the day of vaccination, according to Investigator judgment.
- •Thrombocytopenia or bleeding disorder contraindicated for vaccination with same administration route, or receipt of anticoagulants in the 3 weeks preceding inclusion.
结局指标
主要结局
Percentage of Participants With Seroconversion to Japanese Encephalitis Chimeric Virus Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine
时间窗: Day 28 post-vaccination
Immunogenicity assessed using a Japanese encephalitis chimeric virus (JE-CV) 50% Plaque Reduction Neutralization Test (PRNT50). Seroconversion was defined as the percentage of participants who developed neutralizing antibody titers above 10 (1/dil) when seronegative at baseline (\<1/10) or who presented a ≥4-fold rise in their neutralizing antibody titers when seropositive (≥1/10) at baseline.
次要结局
- Geometric Mean Titers Against the Japanese Encephalitis Chimeric Virus Before And Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine(Day 0 (pre-vaccination) and Day 28 post-vaccination)
- Number of Participants With Seroprotection Against Japanese Encephalitis Chimeric Virus Before And Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine(Day 0 (pre-vaccination) and Day 28 post-vaccination)
- Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine(Day 0 up to Day 14 post-vaccination)
研究者
研究点 (6)
Loading locations...
相似试验
已完成
3 期
A Study of Japanese Encephalitis Chimeric Virus Vaccine Compared With SA14-14-2 Vaccine in Infants and ToddlersJapanese EncephalitisEncephalitisNCT01092507Sanofi Pasteur, a Sanofi Company300
已完成
3 期
Study of Japanese Encephalitis Chimeric Virus Vaccine Given With Measles-Mumps-Rubella Vaccine in Taiwanese ToddlersJapanese EncephalitisMeaslesRubellaMumpsNCT01188343Sanofi Pasteur, a Sanofi Company542
已完成
4 期
Live Attenuated Japanese Encephalitis (JE) Vaccine Coadministered With Measles Vaccine in Infants 9 Months of AgeJapanese EncephalitisNCT00463684PATH278
已完成
4 期
Boosterability of Live Attenuated Japanese Encephalitis (JE) Vaccine in Children Who Have Previously Received Inactivated JE VaccineJapanese EncephalitisNCT00463476PATH305
已完成
3 期
Concomitant Vaccination With the Japanese Encephalitis Vaccine IC51 and HARVIX® 1440Japanese EncephalitisNCT00596271Valneva Austria GmbH192