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Comparison of Three Batches of the Japanese Encephalitis Vaccine IC51

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Intercell AG
ClinicalTrials.gov Identifier:
NCT00594958
First received: January 4, 2008
Last updated: October 19, 2012
Last verified: October 2012
History of Changes

January 4, 2008
October 19, 2012
September 2006
April 2007   (final data collection date for primary outcome measure)
GMT for anti-JEV neutralizing antibody [ Time Frame: day 56 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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
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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00594958
IC51-309
No
Intercell AG
Intercell AG
Not Provided
Study Director: Astrid Kaltenboeck, Ph.D. Intercell AG
Intercell AG
October 2012

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