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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

Tracking Information
First Submitted Date  ICMJE October 20, 2008
First Posted Date  ICMJE October 21, 2008
Results First Submitted Date  ICMJE December 5, 2013
Results First Posted Date  ICMJE January 23, 2014
Last Update Posted Date May 4, 2016
Study Start Date  ICMJE September 2008
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 29, 2016)
Primary: 1. Geometric Mean Titers (GMT) at Day 56 [ Time Frame: 56 days post 1st vaccination ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 20, 2008)
Primary: 1. Geometric Mean Titers (GMT) at Day 56 [ Time Frame: see above ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 20, 2008)
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Immunogenicity of a Commercial Batch of JEV IC51 up to 24 Months Post Filling
Official Title  ICMJE 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
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.
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

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Japanese Encephalitis
Intervention  ICMJE Biological: IC51
6 mcg im. at day 0 and day 28
Other Name: Japanese Encephalitis vaccine
Study Arms  ICMJE
  • Active Comparator: IC51 (~12 months post filling)
    6 mcg (~12 months post filling)
    Intervention: Biological: IC51
  • Active Comparator: IC51 (~18 months post filling)
    6 mcg (~18 months post filling)
    Intervention: Biological: IC51
  • Active Comparator: IC51 (~24 months post filling)
    6 mcg (~24 months post filling)
    Intervention: Biological: IC51
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 19, 2012)
304
Original Estimated Enrollment  ICMJE
 (submitted: October 20, 2008)
300
Actual Study Completion Date  ICMJE June 2010
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00776230
Other Study ID Numbers  ICMJE IC51-314
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Valneva Austria GmbH
Study Sponsor  ICMJE Valneva Austria GmbH
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Evelyn Hatzenbichler Valneva Austria GmbH
PRS Account Valneva Austria GmbH
Verification Date March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP