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Immunogenicity of a Commercial Batch of JEV IC51 up to 24 Months Post Filling

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00776230
Recruitment Status : Completed
First Posted : October 21, 2008
Results First Posted : January 23, 2014
Last Update Posted : May 4, 2016
Sponsor:
Information provided by (Responsible Party):
Valneva Austria GmbH

Brief Summary:
The objective is to assess immunogenicity of a commercial IC51 batch at 3 different time points post filling (12, 18, 24 months) in terms of Geometric Mean Titers (GMT) for anti-JEV neutralizing antibodies at Day 56 after the first vaccination.

Condition or disease Intervention/treatment Phase
Japanese Encephalitis Biological: IC51 Phase 3

Detailed Description:

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

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Encephalitis

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 Outcome Measures :
  1. Primary: 1. Geometric Mean Titers (GMT) at Day 56 [ Time Frame: 56 days post 1st vaccination ]

Secondary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

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


Locations
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Austria
Zentrum für Reisemedizin
Vienna, Austria, 1090
Germany
Berliner Zentrum Reise- und Tropenmedizin
Berlin, Germany, 10117
Universitätsklinikum Rostock
Rostock, Germany, 18057
Sponsors and Collaborators
Valneva Austria GmbH
Investigators
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Study Director: Evelyn Hatzenbichler Valneva Austria GmbH
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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
Additional relevant MeSH terms:
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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