Immune Response in IXIARO Batch JEV09L37 Recipients Before and After Revaccination

NCT01559831 | Withdrawn Phase 1

• 1 other identifier: IC51-319
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Japanese Encephalitis

Keywords

Japanese Encephalitis; IXIARO; Japanese Encephalitis Vaccine

Outcome Measures

Primary Outcomes (1)

• Seroconversion rate (SCR) at Day 28

  at Day 28

Secondary Outcomes (3)

• 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

Study Arms (1)

IXIARO

OTHER

IXIARO, applied according to licensed dose, intramuscular

Biological: IXIARO

Interventions

IXIARO BIOLOGICAL

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

IXIARO

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Valneva Austria GmbH: lead

Study Sites (1)

UCLH Foundation Trust

London, London, WC1E 6JB, United Kingdom

Location

MeSH Terms

Conditions

Encephalitis, Japanese

Condition Hierarchy (Ancestors)

Encephalitis, Arbovirus; Encephalitis, Viral; Central Nervous System Viral Diseases; Central Nervous System Infections; Infections; Infectious Encephalitis; Arbovirus Infections; Vector Borne Diseases; Mosquito-Borne Diseases; Virus Diseases; RNA Virus Infections; Flavivirus Infections; Flaviviridae Infections; Encephalitis; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neuroinflammatory Diseases

Study Officials

• Vera Kadlecek, Mag.

  Valneva Austria GmbH

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2012
• First Posted: March 21, 2012
• Study Start: June 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: March 1, 2013
• Last Updated: March 8, 2013

Record last verified: 2013-03

Locations

GB (1)