Rapid Immunization Study of the Japanese Encephalitis Vaccine IC51
Phase 3 Study to Compare a Rapid Immunization Regime With the Standard Regime of IC51 as Vaccine for Japanese Encephalitis
1 other identifier
interventional
374
0 countries
N/A
Brief Summary
The study investigates a rapid immunization regime of the Japanese Encephalitis vaccine IC51 (JE-PIV) in healthy subjects aged \> or = 18 years
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Sep 2005
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2007
CompletedFirst Submitted
Initial submission to the registry
January 4, 2008
CompletedFirst Posted
Study publicly available on registry
January 16, 2008
CompletedResults Posted
Study results publicly available
March 26, 2014
CompletedApril 29, 2014
April 1, 2014
5 months
January 4, 2008
December 5, 2013
April 9, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
SCR (Seroconversion Rate) at Day 56
Seroconversion rate: percentage of subjects with \>= 1:10 anti-JEV neutralizing antibody titer
day 56
Secondary Outcomes (3)
SCR at Day 10, 28 and 35
Day 10, 28 and 35
GMT at Day 10, 28, 35 and 56
Day 10, 28, 35 and 56
Safety
Study duration
Study Arms (3)
IC51 2 x 6 mcg
ACTIVE COMPARATOR2 x 6 mcg (microgram)
IC51 1 x 12 mcg
ACTIVE COMPARATOR1 x 12 mcg (microgram)
IC51 1 x 6 mcg
ACTIVE COMPARATOR1 x 6 mcg (microgram)
Interventions
Eligibility Criteria
You may qualify if:
- At least 18 years of age
- Written informed consent obtained prior to study entry
You may not qualify if:
- History of clinical manifestation of any flavivirus infection
- 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
- Immunodeficiency including post-organ-transplantation or immunosuppressive therapy
- A family history of congenital or hereditary immunodeficiency
- History of autoimmune disease
- Any acute infections within 4 weeks prior to enrollment
- Infection with HIV, Hepatitis B or Hepatitis C
- Pregnancy, lactation or unreliable contraception in female subjects
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Manager Clinical Research
- Organization
- Intercell AG
Study Officials
- STUDY DIRECTOR
Susanne Eder, Mag.
Valneva Austria GmbH
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 4, 2008
First Posted
January 16, 2008
Study Start
September 1, 2005
Primary Completion
February 1, 2006
Study Completion
November 1, 2007
Last Updated
April 29, 2014
Results First Posted
March 26, 2014
Record last verified: 2014-04