Comparison of Three Batches of the Japanese Encephalitis Vaccine IC51

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Valneva Austria GmbH
ClinicalTrials.gov Identifier:
NCT00594958
First received: January 4, 2008
Last updated: May 5, 2014
Last verified: May 2014
  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:


Further study details as provided by Valneva Austria GmbH:

Primary Outcome Measures:
  • GMT for Anti-JEV Neutralizing Antibody [ Time Frame: day 56 ] [ Designated as safety issue: No ]
    Equivalence between batches with regards to GMT was postulated if all three pair-wise 95 % Confidence Intervals for GMT ratios were between 0.5 and 2.


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: 636
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators
Valneva Austria GmbH
Investigators
Study Director: Susanne Eder, Mag. Valneva Austria GmbH
  More Information

No publications provided

Responsible Party: Valneva Austria GmbH
ClinicalTrials.gov Identifier: NCT00594958     History of Changes
Other Study ID Numbers: IC51-309
Study First Received: January 4, 2008
Results First Received: December 5, 2013
Last Updated: May 5, 2014
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 September 18, 2014