Immune Response in IXIARO Batch JEV09L37 Recipients Before and After Revaccination

Immune Responses to Revaccination After Potentially Insufficient Priming With the Japanese Encephalitis Vaccine IXIARO Batch JEV09L37

Status

Withdrawn

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01559831

Enrollment

Registered

2012-03-21

Start date

2012-06-30

Completion date

2013-03-31

Last updated

2013-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Japanese Encephalitis

Keywords

Japanese Encephalitis, IXIARO, Japanese Encephalitis Vaccine

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.

Interventions

BIOLOGICALIXIARO

Vero-cell derived Japanese encephalitis (JE) vaccine IXIARO, 0.5 ml intramuscular

Study design

Allocation

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Seroconversion rate (SCR) at Day 28	at Day 28

Secondary

Measure	Time frame
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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026