Safety and Tolerability of the Japanese Encephalitis Vaccine IC51

This study has been completed.
Sponsor:
Information provided by:
Valneva Austria GmbH
ClinicalTrials.gov Identifier:
NCT00605085
First received: January 4, 2008
Last updated: October 19, 2012
Last verified: October 2012
  Purpose

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 Intervention Phase
Japanese Encephalitis
Biological: Japanese Encephalitis purified inactivated vaccine (IC51)
Biological: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Safety and Tolerability of the Japanese Encephalitis Vaccine IC51. Double Blind, Randomized, Placebo Controlled Phase 3 Study

Resource links provided by NLM:


Further study details as provided by Valneva Austria GmbH:

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


Secondary Outcome Measures:
  • Rates of Serious Adverse Events and Medically Attended Adverse Events [ Time Frame: until Day 56 ] [ Designated as safety issue: Yes ]
  • Changes in Laboratory Parameters [ Time Frame: until Day 56 ] [ Designated as safety issue: Yes ]
  • SCR and GMT of Subjects With Concomitant Vaccinations [ Time Frame: until Day 56 ] [ Designated as safety issue: No ]

Enrollment: 2675
Study Start Date: October 2005
Study Completion Date: November 2006
Arms Assigned Interventions
Experimental: 1
IC51
Biological: Japanese Encephalitis purified inactivated vaccine (IC51)
IC51 (JE-PIV), 6 mcg, i.m. injection, 2 vaccinations, days 0 and 28
Placebo Comparator: 2
Placebo
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  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: NCT00605085

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

No publications provided

Responsible Party: Intercell AG
ClinicalTrials.gov Identifier: NCT00605085     History of Changes
Other Study ID Numbers: IC51-302
Study First Received: January 4, 2008
Results First Received: June 1, 2012
Last Updated: October 19, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Encephalitis
Encephalitis, Japanese
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 July 20, 2014