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Comparison of Three Batches of the Japanese Encephalitis Vaccine IC51

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ClinicalTrials.gov Identifier: NCT00594958
Recruitment Status : Completed
First Posted : January 16, 2008
Results First Posted : January 23, 2014
Last Update Posted : May 4, 2016
Sponsor:
Information provided by (Responsible Party):
Valneva Austria GmbH

January 4, 2008
January 16, 2008
December 5, 2013
January 23, 2014
May 4, 2016
September 2006
April 2007   (Final data collection date for primary outcome measure)
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.
Geometric Mean Titers for anti-JEV neutralizing antibody
Complete list of historical versions of study NCT00594958 on ClinicalTrials.gov Archive Site
  • Safety [ Time Frame: study duration ]
    Safety laboratory parameters, rate of SAEs and medically attended AEs, systemic and local tolerability
  • SCR for Anti-JEC Neutralizing Antibody Titer [ Time Frame: day 56 ]
Safety and Adverse Events
Not Provided
Not Provided
 
Comparison of Three Batches of the Japanese Encephalitis Vaccine IC51
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.

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.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Japanese Encephalitis
Biological: IC51
6 mcg, intramuscularly [i.m.], 0.5 mL
Other Name: Japanese Encephalitis purified inactivated vaccine
  • 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
    Intervention: Biological: IC51
  • 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
    Intervention: Biological: IC51
  • 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
    Intervention: Biological: IC51
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
639
731
September 2007
April 2007   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00594958
IC51-309
No
Not Provided
Not Provided
Valneva Austria GmbH
Valneva Austria GmbH
Not Provided
Study Director: Susanne Eder, Mag. Valneva Austria GmbH
Valneva Austria GmbH
March 2016

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