Safety and Tolerability of the Japanese Encephalitis Vaccine IC51
Primary Purpose
Japanese Encephalitis
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Japanese Encephalitis purified inactivated vaccine (IC51)
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Japanese Encephalitis
Eligibility Criteria
Inclusion Criteria:
- At least 18 years of age
- Written informed consent obtained prior to study entry
Exclusion Criteria:
- Use of any other investigational or non-registered drug or vaccine in addition to the study vaccine during the study period or within 30 days preceding the first dose of study vaccine
- History of any previous JE vaccination (e.g. JE-VAX®)
- Immunodeficiency including post-organ-transplantation or immunosuppressive therapy
- A family history of congenital or hereditary immunodeficiency
- History of autoimmune disease
- Any acute infections within 2 weeks prior to enrollment
- Known or suspected HIV Infection
- Pregnancy, lactation or unreliable contraception in female subjects
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
IC51
Placebo
Outcomes
Primary Outcome Measures
Safety and Tolerability up to Day 56
calculation based on safety population, numbers provide percentages of participants with Adverse Events (AEs)
Secondary Outcome Measures
Rates of Serious Adverse Events and Medically Attended Adverse Events
Changes in Laboratory Parameters
SCR and GMT of Subjects With Concomitant Vaccinations
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00605085
Brief Title
Safety and Tolerability of the Japanese Encephalitis Vaccine IC51
Official Title
Safety and Tolerability of the Japanese Encephalitis Vaccine IC51. Double Blind, Randomized, Placebo Controlled Phase 3 Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Valneva Austria GmbH
4. Oversight
5. Study Description
Brief Summary
The objective is to investigate the safety and tolerability of Japanese Encephalitis vaccine IC51 with an inactive control in healthy subjects aged > or = 18 years
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Japanese Encephalitis
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
2675 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
IC51
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Biological
Intervention Name(s)
Japanese Encephalitis purified inactivated vaccine (IC51)
Intervention Description
IC51 (JE-PIV), 6 mcg, i.m. injection, 2 vaccinations, days 0 and 28
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Placebo: Phosphate-buffered saline (PBS) solution containing 0.1% aluminum hydroxide as an adjuvant, 0.5 mL, i.m. injection, 2 injections, days 0 and 28
Primary Outcome Measure Information:
Title
Safety and Tolerability up to Day 56
Description
calculation based on safety population, numbers provide percentages of participants with Adverse Events (AEs)
Time Frame
Day 56
Secondary Outcome Measure Information:
Title
Rates of Serious Adverse Events and Medically Attended Adverse Events
Time Frame
until Day 56
Title
Changes in Laboratory Parameters
Time Frame
until Day 56
Title
SCR and GMT of Subjects With Concomitant Vaccinations
Time Frame
until Day 56
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
At least 18 years of age
Written informed consent obtained prior to study entry
Exclusion Criteria:
Use of any other investigational or non-registered drug or vaccine in addition to the study vaccine during the study period or within 30 days preceding the first dose of study vaccine
History of any previous JE vaccination (e.g. JE-VAX®)
Immunodeficiency including post-organ-transplantation or immunosuppressive therapy
A family history of congenital or hereditary immunodeficiency
History of autoimmune disease
Any acute infections within 2 weeks prior to enrollment
Known or suspected HIV Infection
Pregnancy, lactation or unreliable contraception in female subjects
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Astrid Kaltenboeck, Ph.D.
Organizational Affiliation
Valneva Austria GmbH
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Safety and Tolerability of the Japanese Encephalitis Vaccine IC51
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