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Comparison of Three Batches of the Japanese Encephalitis Vaccine IC51

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: 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

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

Condition or disease Intervention/treatment Phase
Japanese Encephalitis Biological: IC51 Phase 3

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 639 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Comparison of Three Batches of the Japanese Encephalitis Vaccine IC51. Double Blind, Randomized, Controlled Phase 3 Study.
Study Start Date : September 2006
Actual Primary Completion Date : April 2007
Actual Study Completion Date : September 2007

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Safety [ Time Frame: study duration ]
    Safety laboratory parameters, rate of SAEs and medically attended AEs, systemic and local tolerability

  2. SCR for Anti-JEC Neutralizing Antibody Titer [ Time Frame: day 56 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00594958


Sponsors and Collaborators
Valneva Austria GmbH
Investigators
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Study Director: Susanne Eder, Mag. Valneva Austria GmbH
More Information
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Responsible Party: Valneva Austria GmbH
ClinicalTrials.gov Identifier: NCT00594958    
Other Study ID Numbers: IC51-309
First Posted: January 16, 2008    Key Record Dates
Results First Posted: January 23, 2014
Last Update Posted: May 4, 2016
Last Verified: March 2016
Additional relevant MeSH terms:
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Encephalitis, Japanese
Encephalitis
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Encephalitis, Arbovirus
Encephalitis, Viral
Central Nervous System Viral Diseases
Central Nervous System Infections
Infections
 Infectious Encephalitis
Arbovirus Infections
Vector Borne Diseases
Virus Diseases
RNA Virus Infections
Flavivirus Infections
Flaviviridae Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs