Comparison of Three Batches of the Japanese Encephalitis Vaccine IC51
1 other identifier
interventional
639
0 countries
N/A
Brief Summary
The objective is to demonstrate equivalence of three IC51 batches in terms of Geometric Mean Titers for anti-JEV neutralizing antibody.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2006
Shorter than P25 for phase_3
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, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
September 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
January 23, 2014
CompletedMarch 21, 2024
March 1, 2024
7 months
January 4, 2008
December 5, 2013
March 20, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
GMT for Anti-JEV Neutralizing Antibody
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 Outcomes (2)
Safety
study duration
SCR for Anti-JEC Neutralizing Antibody Titer
day 56
Study Arms (3)
IC51 Group A
ACTIVE COMPARATORIC51 (JE-PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches
IC51 Group B
ACTIVE COMPARATORIC51 (JE-PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches
IC51 Group C
ACTIVE COMPARATORIC51 (JE-PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches
Interventions
6 mcg, intramuscularly \[i.m.\], 0.5 mL
Eligibility Criteria
You may qualify if:
- Male and female subjects aged at least 18 years with written informed consent and either no childbearing potential or negative pregnancy test
You may not qualify if:
- History of immunodeficiency or immunosuppressive therapy, known HIV, drug addiction including alcohol dependence
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
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- 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, 2006
Primary Completion
April 1, 2007
Study Completion
September 1, 2007
Last Updated
March 21, 2024
Results First Posted
January 23, 2014
Record last verified: 2024-03