NCT01559831WithdrawnPhase 1
Immune Responses to Revaccination After Potentially Insufficient Priming With the Japanese Encephalitis Vaccine IXIARO Batch JEV09L37
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 1
- Status
- Withdrawn
- Sponsor
- Valneva Austria GmbH
- Locations
- 1
- Primary Endpoint
- Seroconversion rate (SCR) at Day 28
Study Overview
Brief Summary
IC51-319 is a single-arm, open-label study that investigates immune responses in subjects undergoing revaccination after receiving the subpotent batch of IXIARO JEV09L37 during primary immunization.
Detailed Description
IC51-319 is a single-arm, open-label study that investigates immune responses in subjects undergoing revaccination after receiving the subpotent batch of IXIARO JEV09L37 during primary immunization.
A total of up to 50 subjects having received primary immunization of IXIARO batch JEV09L37 and who have not yet been revaccinated.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Subjects 18 years or older having received IXIARO batch JEV09L37 during primary immunization
- •In female subjects, either childbearing potential terminated by surgery or 1 year post-menopausal, or a negative urine pregnancy test during screening and the willingness not to become pregnant during the entire study period by practicing reliable methods of contraception
- •Written informed consent obtained from the subject prior to any study-related procedures
Exclusion Criteria
- •Vaccination against Yellow fever, Dengue Fever, West Nile Fever or TBE or vaccination with any JE vaccine since primary immunization with IXIARO JEC09L37
- •Clinical manifestation of any flavivirus infection since primary immunization with IXIARO JEC09L37
- •Acute febrile infections or exacerbation of chronic infection on the day of IXIARO vaccination
- •Pregnancy, lactation or unreliable contraception in female subjects with child-bearing potential and unreliable contraception in male subjects.
- •Use of any other investigational or non-registered drug within 30 days prior to the first vaccination with IXIARO Visit 1 and during the study period
- •Any condition which might interfere with study objectives or would limit the subject's ability to complete the study in the opinion of the investigator
- •Persons who are committed to an institution
- •At Day 0, upcoming scheduled travel to a JE endemic region
Arms & Interventions
IXIARO
Other
IXIARO, applied according to licensed dose, intramuscular
Intervention: IXIARO (Biological)
Outcomes
Primary Outcomes
Seroconversion rate (SCR) at Day 28
Time Frame: at Day 28
Secondary Outcomes
- SCR at Day 0(Day 0)
- Geometric Mean Titer at Day 0 and 28(Day 0 and Day 28)
- Rate of Adverse Events up to Day 28(Day 28)
Investigators
Study Sites (1)
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