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Immune Response in IXIARO Batch JEV09L37 Recipients Before and After Revaccination

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Valneva Austria GmbH
ClinicalTrials.gov Identifier:
NCT01559831
First received: March 19, 2012
Last updated: March 7, 2013
Last verified: March 2013

March 19, 2012
March 7, 2013
June 2012
December 2012   (final data collection date for primary outcome measure)
Seroconversion rate (SCR) at Day 28 [ Time Frame: at Day 28 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01559831 on ClinicalTrials.gov Archive Site
  • SCR at Day 0 [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
  • Geometric Mean Titer at Day 0 and 28 [ Time Frame: Day 0 and Day 28 ] [ Designated as safety issue: No ]
  • Rate of Adverse Events up to Day 28 [ Time Frame: Day 28 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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

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.

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.

Interventional
Phase 1
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Japanese Encephalitis
Biological: IXIARO
Vero-cell derived Japanese encephalitis (JE) vaccine IXIARO, 0.5 ml intramuscular
IXIARO
IXIARO, applied according to licensed dose, intramuscular
Intervention: Biological: IXIARO
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
March 2013
December 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01559831
IC51-319
No
Valneva Austria GmbH
Valneva Austria GmbH
Not Provided
Study Chair: Vera Kadlecek, Mag. Valneva Austria GmbH
Valneva Austria GmbH
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP