EUCTR2005-000253-29-GB进行中（未招募）1 期
ONG TERM IMMUNOGENICITY OF THE JAPANESE ENCEPHALITIS VACCINE IC51 (JE-PIV). AN UNCONTROLLED PHASE 3 FOLLOW-UP STUDY - IC51-303
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Intercell AG
- 入组人数
- 4,333
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •-Subjects correctly included in and having completed clinical studies IC51-301 or
- •IC51-302 with at least one vaccination.
- •-Written informed consent for study IC51-303.
- •Only for the immunogenicity part:
- •-Subjects correctly included in and having completed study IC51-301 or IC51-302 according to the protocol with the required amount of injections (IC51-301: 3 / IC51-302: 2).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •-Inability or unwillingness to provide informed consent and to abide by the requirements of the study.
- •Only for the immunogenicity part:
- •-Known negative (< 1:10) anti-JEV neutralizing antibody titer (PRNT) 28 days after the last vaccination in the preceding study or thereafter.
- •-Subjects with any condition which in the opinion of the Investigator makes the subject unsuitable for inclusion.
研究者
相似试验
进行中（未招募）
不适用
ONG TERM IMMUNOGENICITY OF THE JAPANESE ENCEPHALITIS VACCINEIC51 (JE-PIV). AN UNCONTROLLED PHASE 3 FOLLOW-UP STUDY - IC51-303Japanese encephalitis. This study is a follow-up to the pivotal immunogenicity and safety studies IC51-301 and IC51-302.EUCTR2005-000253-29-DEIntercell AG3,300
进行中（未招募）
不适用
ONG TERM IMMUNOGENICITY OF THE JAPANESE ENCEPHALITIS VACCINEIC51 (JE-PIV). AN UNCONTROLLED PHASE 3 FOLLOW-UP STUDY - IC51-303EUCTR2005-000253-29-ATIntercell AG3,300
尚未招募
3 期
ong Term Immunogenicity of the JE Vaccine IC51Prophylactic Vaccine against Japanese EncephalitisNeurological - Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)ACTRN12605000681651Intercell AG600
进行中（未招募）
不适用
Immunogenicity and Safety of the Japanese Encephalitis Vaccine IC51 (IXIARO®, JESPECT®) in a Pediatric Population in Non-endemic CountriesJapanese Encephalitis (JE)MedDRA version: 13.1Level: PTClassification code 10014596Term: Encephalitis Japanese BSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 13.1Level: LLTClassification code 10023120Term: Japanese B viral encephalitisSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 13.1Level: LLTClassification code 10023123Term: Japanese encephalitisSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 13.1Level: LLTClassification code 10023122Term: Japanese B virus encephalitisSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 13.1Level: LLTClassification code 10023119Term: Japanese B encephalitisSystem Organ Class: 10021881 - Infections and infestationsEUCTR2009-015595-10-SEIntercell AG100
进行中（未招募）
不适用
IMMUNOGENICITY AND SAFETY OF THE JAPANESE ENCEPHALITIS VACCINE IC51 (IXIARO®, JESPECT®) IN A PEDIATRIC POPULATION IN NON-ENDEMIC COUNTRIES. UNCONTROLLED, OPEN-LABEL PHASE 3 STUDYJapanese Encephalitis (JE)MedDRA version: 12.0Level: LLTClassification code 10014596Term: Encephalitis Japanese BMedDRA version: 12.0Level: LLTClassification code 10023119Term: Japanese B encephalitisMedDRA version: 12.0Level: LLTClassification code 10023120Term: Japanese B viral encephalitisMedDRA version: 12.0Level: LLTClassification code 10023122Term: Japanese B virus encephalitisMedDRA version: 12.0Level: LLTClassification code 10023123Term: Japanese encephalitisEUCTR2009-015595-10-DKIntercell AG100