Comparison of Three Batches of the Japanese Encephalitis Vaccine IC51
March 20, 2024 updated by: Valneva Austria GmbH
Comparison of Three Batches of the Japanese Encephalitis Vaccine IC51. Double Blind, Randomized, Controlled Phase 3 Study.
The objective is to demonstrate equivalence of three IC51 batches in terms of Geometric Mean Titers for anti-JEV neutralizing antibody.
Study Overview
Detailed Description
This is a randomized, controlled, multi-center, double blind phase 3 study. The study population consists of male and female healthy subjects, aged at least 18 years.
624 subjects will be enrolled at approximately 6 sites in study centers in Austria and Germany.
Study Type
Interventional
Enrollment (Actual)
639
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Main Inclusion Criteria:
- Male and female subjects aged at least 18 years with written informed consent and either no childbearing potential or negative pregnancy test
Main Exclusion Criteria:
- History of immunodeficiency or immunosuppressive therapy, known HIV, drug addiction including alcohol dependence
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: IC51 Group A
IC51 (JE-PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches
|
6 mcg, intramuscularly [i.m.], 0.5 mL
Other Names:
|
|
Active Comparator: IC51 Group B
IC51 (JE-PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches
|
6 mcg, intramuscularly [i.m.], 0.5 mL
Other Names:
|
|
Active Comparator: IC51 Group C
IC51 (JE-PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches
|
6 mcg, intramuscularly [i.m.], 0.5 mL
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
GMT for Anti-JEV Neutralizing Antibody
Time Frame: day 56
|
Equivalence between batches with regards to GMT (Geometric Mean Titer) was postulated if all three pair-wise 95 % Confidence Intervals for GMT ratios were between 0.5 and 2.
|
day 56
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Safety
Time Frame: study duration
|
Safety laboratory parameters, rate of SAEs and medically attended AEs, systemic and local tolerability
|
study duration
|
|
SCR for Anti-JEC Neutralizing Antibody Titer
Time Frame: day 56
|
day 56
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Susanne Eder, Mag., Valneva Austria GmbH
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2006
Primary Completion (Actual)
April 1, 2007
Study Completion (Actual)
September 1, 2007
Study Registration Dates
First Submitted
January 4, 2008
First Submitted That Met QC Criteria
January 15, 2008
First Posted (Estimated)
January 16, 2008
Study Record Updates
Last Update Posted (Actual)
March 21, 2024
Last Update Submitted That Met QC Criteria
March 20, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Encephalitis, Arbovirus
- Encephalitis, Viral
- Central Nervous System Viral Diseases
- Central Nervous System Infections
- Infectious Encephalitis
- Arbovirus Infections
- Vector Borne Diseases
- Flavivirus Infections
- Flaviviridae Infections
- Neuroinflammatory Diseases
- Mosquito-Borne Diseases
- Encephalitis, Japanese
- Encephalitis
- Physiological Effects of Drugs
- Immunologic Factors
- Vaccines
Other Study ID Numbers
- IC51-309
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.