Immunogenicity of a Commercial Batch of JEV IC51 up to 24 Months Post Filling
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ClinicalTrials.gov Identifier: NCT00776230 |
Recruitment Status :
Completed
First Posted : October 21, 2008
Results First Posted : January 23, 2014
Last Update Posted : May 4, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Japanese Encephalitis | Biological: IC51 | Phase 3 |
Open-label, multicenter, phase 3 study assessing immunogenicity at various time points throughout the shelf-life of a commercial batch of IC51 (Batch IC51/07F/008) The study population consists of male and female healthy subjects, aged at least 18 years.
The study will be performed at 3 study centers in Germany and Austria. Three sequential cohorts, each containing 100 subjects, will be enrolled into the study at approximately 12, 18 and 24 months after filling of the commercial batch IC51/07F/008 of IC51
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 304 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Immunogenicity of a Commercial Batch of the Japanese Encephalitis Vaccine IC51 up to Twenty-four Months Post Filling. An Open-label, Multicenter, Phase 3 Study |
Study Start Date : | September 2008 |
Actual Primary Completion Date : | June 2010 |
Actual Study Completion Date : | June 2010 |

Arm | Intervention/treatment |
---|---|
Active Comparator: IC51 (~12 months post filling)
6 mcg (~12 months post filling)
|
Biological: IC51
6 mcg im. at day 0 and day 28
Other Name: Japanese Encephalitis vaccine |
Active Comparator: IC51 (~18 months post filling)
6 mcg (~18 months post filling)
|
Biological: IC51
6 mcg im. at day 0 and day 28
Other Name: Japanese Encephalitis vaccine |
Active Comparator: IC51 (~24 months post filling)
6 mcg (~24 months post filling)
|
Biological: IC51
6 mcg im. at day 0 and day 28
Other Name: Japanese Encephalitis vaccine |
- Primary: 1. Geometric Mean Titers (GMT) at Day 56 [ Time Frame: 56 days post 1st vaccination ]
- Secondary: 1. Seroconversion Rate 2. GMTs Day 28, Month 6 and Month 12 3. Treatment Emergent Adverse Events 4. Systemic and Local Tolerability [ Time Frame: see above ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Male and female healthy adults aged at least 18 years with written informed consent and either no childbearing potential or negative pregnancy test.
Exclusion Criteria:
- History of immunodeficiency or immunosuppressive therapy, known HIV infection, drug addiction including alcohol dependence, prior vaccination against JE

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00776230
Austria | |
Zentrum für Reisemedizin | |
Vienna, Austria, 1090 | |
Germany | |
Berliner Zentrum Reise- und Tropenmedizin | |
Berlin, Germany, 10117 | |
Universitätsklinikum Rostock | |
Rostock, Germany, 18057 |
Study Director: | Evelyn Hatzenbichler | Valneva Austria GmbH |
Responsible Party: | Valneva Austria GmbH |
ClinicalTrials.gov Identifier: | NCT00776230 |
Other Study ID Numbers: |
IC51-314 |
First Posted: | October 21, 2008 Key Record Dates |
Results First Posted: | January 23, 2014 |
Last Update Posted: | May 4, 2016 |
Last Verified: | March 2016 |
Encephalitis, Japanese Encephalitis Brain Diseases Central Nervous System Diseases Nervous System Diseases Encephalitis, Arbovirus Arbovirus Infections Virus Diseases Encephalitis, Viral |
Central Nervous System Viral Diseases RNA Virus Infections Flavivirus Infections Flaviviridae Infections Infectious Encephalitis Central Nervous System Infections Vaccines Immunologic Factors Physiological Effects of Drugs |