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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
  Purpose

The objective is to demonstrate equivalence of three IC51 batches in terms of Geometric Mean Titers for anti-JEV neutralizing antibody.


Condition Intervention Phase
Japanese Encephalitis
 Biological: IC51
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Comparison of Three Batches of the Japanese Encephalitis Vaccine IC51. Double Blind, Randomized, Controlled Phase 3 Study.

Resource links provided by NLM:

MedlinePlus related topics: Encephalitis
U.S. FDA Resources

Further study details as provided by Intercell AG:

Primary Outcome Measures:
  • GMT for anti-JEV neutralizing antibody [ Time Frame: day 56 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 731
Study Start Date: September 2006
Study Completion Date: September 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
 Biological: IC51
6 mcg, intramuscularly [i.m.], 0.5 mL
Other Name: Japanese Encephalitis purified inactivated vaccine
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
 Biological: IC51
6 mcg, intramuscularly [i.m.], 0.5 mL
Other Name: Japanese Encephalitis purified inactivated vaccine
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
 Biological: IC51
6 mcg, intramuscularly [i.m.], 0.5 mL
Other Name: Japanese Encephalitis purified inactivated vaccine

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00594958

Sponsors and Collaborators
Intercell AG
Investigators
Study Director: Astrid Kaltenboeck, Ph.D. Intercell AG
  More Information

No publications provided

Responsible Party: Intercell AG
ClinicalTrials.gov Identifier: NCT00594958     History of Changes
Other Study ID Numbers: IC51-309
Study First Received: January 4, 2008
Last Updated: October 19, 2012
Health Authority: Germany: Paul-Ehrlich-Institut
Austria: Agency for Health and Food Safety
United States: Food and Drug Administration

Additional relevant MeSH terms:
Encephalitis, Japanese
Encephalitis
Central Nervous System Viral Diseases
Virus Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Central Nervous System Infections
Encephalitis, Arbovirus
Arbovirus Infections
Encephalitis, Viral
RNA Virus Infections
Flavivirus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on June 18, 2013