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WithdrawnNCT01559831Updated Mar 8, 2013

Immune Response in IXIARO Batch JEV09L37 Recipients Before and After Revaccination

A Phase 1 interventional study of IXIARO in Japanese Encephalitis, sponsored by Valneva Austria GmbH. Withdrawn at 1 site in United Kingdom. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-03-08.

Sponsored by Valneva Austria GmbH · Phase 1 and Interventional

Phase
Phase 1
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Japanese Encephalitis

Keywords

  • Japanese Encephalitis
  • IXIARO
  • Japanese Encephalitis Vaccine
03

In context

Encephalitis, Japanese

77 studies on the registry are indexed under Encephalitis, Japanese; 4 are open to participants now.

Browse Encephalitis, Japanese studies →

Lead sponsor

Valneva Austria GmbH is the lead sponsor of 44 studies on the registry; 2 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 4 (57%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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
05

Study design

Phase
Phase 1
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Other
    IXIARO

    IXIARO, applied according to licensed dose, intramuscular

    Biological: IXIARO

Interventions

  • BiologicalIXIARO

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

06

What researchers measure

Primary outcomes

  1. Seroconversion rate (SCR) at Day 28

    Time frame: at Day 28

Secondary outcomes

  1. SCR at Day 0

    Time frame: Day 0

  2. Geometric Mean Titer at Day 0 and 28

    Time frame: Day 0 and Day 28

  3. Rate of Adverse Events up to Day 28

    Time frame: Day 28

07

Study locations

1 site
  • UCLH Foundation Trust
    London, WC1E 6JB, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 8, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01559831
Lead sponsor
Valneva Austria GmbH
Responsible party
Sponsor
First posted
Mar 21, 2012
Start date
Jun 2012
Primary completion
Dec 2012 (estimated)
Completion
Mar 2013 (estimated)
Last update
Mar 8, 2013

Study contacts

Vera Kadlecek, Mag.
study chair · Valneva Austria GmbH

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Mar 2013. You cannot join it, but the record below documents what was studied.

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