Immune Response in IXIARO Batch JEV09L37 Recipients Befor... | NCT01559831

Studies
Immune Response in IXIARO Batch JEV09L37 Recipients Before and After Revaccination

NCT01559831

Sponsor

Valneva Austria GmbH

Status

Withdrawn

Last Update Posted

Mar 8, 2013Estimated

Enrollment

0Actual

Phase

Phase 1

Conditions

Japanese Encephalitis

Interventions

IXIARO

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2013

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2012

Primary Completion Date

Dec 2012Estimated

Completion Date

Mar 2013Estimated

First Submitted Date

Mar 19, 2012

First Submission Date that Met QC Criteria

Mar 20, 2012

First Posted Date

Mar 21, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 7, 2013

Last Update Posted Date

Mar 8, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
IXIARO	Other	IXIARO, applied according to licensed dose, intramuscular	Biological: IXIARO

Interventions

Name	Type	Description	Arm Group Labels	Other Names
IXIARO	Biological	Vero-cell derived Japanese encephalitis (JE) vaccine IXIARO, 0.5 ml intramuscular	IXIARO

Measure	Description	Time Frame
Seroconversion rate (SCR) at Day 28		at Day 28

Measure	Description	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

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D004671	Encephalitis, Arbovirus
D018792	Encephalitis, Viral
D020805	Central Nervous System Viral Diseases
D002494	Central Nervous System Infections