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Immunogenicity Study 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. Identifier: NCT00604708
Recruitment Status : Completed
First Posted : January 30, 2008
Results First Posted : November 29, 2012
Last Update Posted : June 2, 2016
Information provided by (Responsible Party):
Valneva Austria GmbH

Brief Summary:
The objective is to demonstrate the non-inferiority of the Japanese Encephalitis vaccine IC51 compared to JE-VAX in healthy subjects aged > or = 18 years

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 867 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Observer Blinded, Randomized Phase 3 Study to Investigate the Non-Inferiority of IC51 vs. JE-VAX as Vaccines for Japanese Encephalitis in Healthy Subjects
Study Start Date : September 2005
Actual Primary Completion Date : September 2006
Actual Study Completion Date : September 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Encephalitis
Drug Information available for: Ixiaro JE-Vax

Arm Intervention/treatment
Experimental: IC51
6 mcg (microgram) i.m. (intramuscular) on Day0, 14 and 28
Biological: IC51
IC51 (JE-PIV), 6 mcg, i.m. injection, 2 vaccinations, days 0 and 28
Other Name: Japanese Encephalitis purified inactivated vaccine

Active Comparator: JE-VAX
given s.c. on Day 0, 7 and 28
Biological: JE-VAX
JE-VAX, 1mL s.c. injection, 3 vaccinations, days 0, 7 and 28

Primary Outcome Measures :
  1. SCR (Seroconversion Rate)of IC51 Compared to JE-VAX at Day 56 [ Time Frame: Day 56 ]
    SCR: anti-JEV neutralizing antibody titer ≥1:10

  2. GMT (Geometric Mean Titer) of IC51 Compared to JE-VAX at Day 56 [ Time Frame: Day 56 ]
    GMT: geometric mean of PRNT50

Secondary Outcome Measures :
  1. Safety and Adverse Events [ Time Frame: until Day 56 ]
  2. Immunogenicity at Day 28 [ Time Frame: Day 28 ]
  3. Immunogenicity at Day 56 for North America vs. Europe [ Time Frame: Day 56 ]
  4. Immunogenicity at Day 56 for Subjects Older vs. Younger Than 50 Years of Age [ Time Frame: Day 56 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • At least 18 years of age
  • Written informed consent obtained prior to study entry

Exclusion Criteria:

  • History of clinical manifestation of any flavivirus infection
  • History of vaccination against Japanese encephalitis (JE), Yellow fever and Dengue fever (an anti-JEV neutralizing antibody titer >= 1:10 at baseline is acceptable for inclusion, these subjects will be part of the safety population, but will not be analyzed for immunogenicity in the per-protocol analysis)
  • Use of any other investigational or non-registered drug or vaccine in addition to the study vaccine during the study period or within 30 days preceding the first dose of study vaccine
  • Immunodeficiency including post-organ-transplantation or immunosuppressive therapy
  • A family history of congenital or hereditary immunodeficiency
  • History of autoimmune disease
  • Any acute infections within 4 weeks prior to enrollment
  • Infection with HIV, Hepatitis B or Hepatitis C
  • Pregnancy, lactation or unreliable contraception in female subjects

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 identifier (NCT number): NCT00604708

Sponsors and Collaborators
Valneva Austria GmbH
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Study Director: Astrid Kaltenboeck, Ph.D. Valneva Austria GmbH

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Responsible Party: Valneva Austria GmbH Identifier: NCT00604708     History of Changes
Other Study ID Numbers: IC51-301
First Posted: January 30, 2008    Key Record Dates
Results First Posted: November 29, 2012
Last Update Posted: June 2, 2016
Last Verified: May 2016

Additional relevant MeSH terms:
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Encephalitis, Japanese
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Encephalitis, Arbovirus
Arbovirus Infections
Virus Diseases
Encephalitis, Viral
Central Nervous System Viral Diseases
RNA Virus Infections
Flavivirus Infections
Flaviviridae Infections
Infectious Encephalitis
Central Nervous System Infections
Immunologic Factors
Physiological Effects of Drugs