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Rapid Immunization Study of the Japanese Encephalitis Vaccine IC51

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ClinicalTrials.gov Identifier: NCT00595790
Recruitment Status : Completed
First Posted : January 16, 2008
Results First Posted : March 26, 2014
Last Update Posted : April 29, 2014
Information provided by (Responsible Party):
Valneva Austria GmbH

Brief Summary:
The study investigates a rapid immunization regime of the Japanese Encephalitis vaccine IC51 (JE-PIV) in healthy subjects aged > or = 18 years

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

Detailed Description:

This is a multicenter, observer blinded, controlled, randomized phase 3 study. The study population consists of healthy male and female volunteers, aged at least 18 years.

Approximately 375 volunteers will be enrolled at approximately 2 to 3 sites.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 374 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Phase 3 Study to Compare a Rapid Immunization Regime With the Standard Regime of IC51 as Vaccine for Japanese Encephalitis
Study Start Date : September 2005
Primary Completion Date : February 2006
Study Completion Date : November 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Encephalitis
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: IC51 2 x 6 mcg
2 x 6 mcg (microgram)
Biological: IC51
Other Name: Japanese Encephalitis purified inactivated vaccine
Active Comparator: IC51 1 x 12 mcg
1 x 12 mcg (microgram)
Biological: IC51
Other Name: Japanese Encephalitis purified inactivated vaccine
Active Comparator: IC51 1 x 6 mcg
1 x 6 mcg (microgram)
Biological: IC51
Other Name: Japanese Encephalitis purified inactivated vaccine

Primary Outcome Measures :
  1. SCR (Seroconversion Rate) at Day 56 [ Time Frame: day 56 ]
    Seroconversion rate: percentage of subjects with >= 1:10 anti-JEV neutralizing antibody titer

Secondary Outcome Measures :
  1. SCR at Day 10, 28 and 35 [ Time Frame: Day 10, 28 and 35 ]
  2. GMT at Day 10, 28, 35 and 56 [ Time Frame: Day 10, 28, 35 and 56 ]
  3. Safety [ Time Frame: Study duration ]
    AEs, Local and systemic tolerability, Safety laboratory parameters

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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 ClinicalTrials.gov identifier (NCT number): NCT00595790

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

Responsible Party: Valneva Austria GmbH
ClinicalTrials.gov Identifier: NCT00595790     History of Changes
Other Study ID Numbers: IC51-304
First Posted: January 16, 2008    Key Record Dates
Results First Posted: March 26, 2014
Last Update Posted: April 29, 2014
Last Verified: April 2014

Additional relevant MeSH terms:
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