Immune Response in IXIARO Batch JEV09L37 Recipients Before and After Revaccination

Valneva

Status and phase: Withdrawn; Phase 1

Conditions: Japanese Encephalitis

Treatments: Biological: IXIARO

Study type: Interventional

Funder types: Industry

Identifiers

NCT01559831

IC51-319

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

0 participants in 1 patient group

IXIARO

Other group

Description:

IXIARO, applied according to licensed dose, intramuscular

Treatment:

Biological: IXIARO