JPRN-jRCT2031200302已完成3 期
A PHASE 3, SINGLE-ARM, OPEN-LABEL STUDY TO EVALUATE THE IMMUNOGENICITY, SAFETY, AND TOLERABILITY OF A TICK-BORNE ENCEPHALITIS VACCINE IN HEALTHY JAPANESE PARTICIPANTS 1 YEAR OF AGE AND OLDER
Kawai Norisuke0 个研究点目标入组 165 人开始时间: 2021年1月15日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 165
研究概览
简要总结
The 3-dose series of TBE vaccine was observed to elicit a robust immune response by TBEV neutralization in Japanese adult and pediatric participants. There was a >=98% TBEV neutralization seropositivity rate demonstrated in both adult and pediatric populations 4 weeks after Dose 3. The safety and tolerability of TBE vaccine in Japanese adult and pediatric participants was acceptable and consistent with the known profile of TBE vaccine.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 1age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Inclusion Criteria:
- •* Japanese male or female participants >=1 years old at Visit 1.
- •* Participants and/or a legally acceptable representative/parent/legal guardian are willing and able to comply with all scheduled visits, vaccination plan, and other study procedures including completion of the e-diary for 7 days for participants after each of 3 vaccinations.
- •* Participants and/or a legally acceptable representative/parent/legal guardian must be able to be contacted by telephone during study participation.
- •* Participants and/or a legally acceptable representative/parent/legal guardian are capable of giving signed informed consent.
排除标准
- •Exclusion Criteria:
- •*Major known congenital malformation or serious chronic disorder.
- •*Known history of TBEV infection.
- •*Known history of other flavivirus infection (eg, dengue fever, yellow fever, JEV, West e virus).
- •*Known history of infection with HIV, HCV, or HBV.
- •*Immunocompromised participants with known or suspected immunodeficiency.
- •*History of autoimmune disease or an active autoimmune disease requiring therapeutic intervention.
- •*Previous vaccination with any licensed or investigational TBE vaccine, or planned receipt of other flavivirus vaccines apart from JEV vaccine (eg, yellow fever, dengue fever) during the study. Administration of JEV vaccine is prohibited during participation.
研究者
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