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Trial record 5 of 7 for:    "Encephalitis" | "Pharmaceutical Solutions"

Safety and Tolerability 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: NCT00605085
Recruitment Status : Completed
First Posted : January 30, 2008
Results First Posted : November 20, 2012
Last Update Posted : November 20, 2012
Information provided by:
Valneva Austria GmbH

Brief Summary:
The objective is to investigate the safety and tolerability of Japanese Encephalitis vaccine IC51 with an inactive control in healthy subjects aged > or = 18 years

Condition or disease Intervention/treatment Phase
Japanese Encephalitis Biological: Japanese Encephalitis purified inactivated vaccine (IC51) Biological: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2675 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Safety and Tolerability of the Japanese Encephalitis Vaccine IC51. Double Blind, Randomized, Placebo Controlled Phase 3 Study
Study Start Date : October 2005
Actual Study Completion Date : November 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Encephalitis

Arm Intervention/treatment
Experimental: 1
Biological: Japanese Encephalitis purified inactivated vaccine (IC51)
IC51 (JE-PIV), 6 mcg, i.m. injection, 2 vaccinations, days 0 and 28

Placebo Comparator: 2
Biological: Placebo
Placebo: Phosphate-buffered saline (PBS) solution containing 0.1% aluminum hydroxide as an adjuvant, 0.5 mL, i.m. injection, 2 injections, days 0 and 28

Primary Outcome Measures :
  1. Safety and Tolerability up to Day 56 [ Time Frame: Day 56 ]
    calculation based on safety population, numbers provide percentages of participants with Adverse Events (AEs)

Secondary Outcome Measures :
  1. Rates of Serious Adverse Events and Medically Attended Adverse Events [ Time Frame: until Day 56 ]
  2. Changes in Laboratory Parameters [ Time Frame: until Day 56 ]
  3. SCR and GMT of Subjects With Concomitant Vaccinations [ Time Frame: until 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:

  • 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
  • History of any previous JE vaccination (e.g. JE-VAX®)
  • Immunodeficiency including post-organ-transplantation or immunosuppressive therapy
  • A family history of congenital or hereditary immunodeficiency
  • History of autoimmune disease
  • Any acute infections within 2 weeks prior to enrollment
  • Known or suspected HIV Infection
  • 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): NCT00605085

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: Intercell AG Identifier: NCT00605085     History of Changes
Other Study ID Numbers: IC51-302
First Posted: January 30, 2008    Key Record Dates
Results First Posted: November 20, 2012
Last Update Posted: November 20, 2012
Last Verified: October 2012
Additional relevant MeSH terms:
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Encephalitis, Japanese
Encephalitis, Arbovirus
Encephalitis, Viral
Infectious Encephalitis
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Arbovirus Infections
Virus Diseases
Central Nervous System Viral Diseases
RNA Virus Infections
Flavivirus Infections
Flaviviridae Infections
Central Nervous System Infections
Immunologic Factors
Physiological Effects of Drugs