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Clinical Trials/NCT00605085
NCT00605085
Completed
Phase 3

Safety and Tolerability of the Japanese Encephalitis Vaccine IC51. Double Blind, Randomized, Placebo Controlled Phase 3 Study

Valneva Austria GmbH0 sites2,675 target enrollmentOctober 2005
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ConditionsJapanese Encephalitis

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Japanese Encephalitis
Sponsor
Valneva Austria GmbH
Enrollment
2675
Primary Endpoint
Safety and Tolerability up to Day 56
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

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

Registry
clinicaltrials.gov
Start Date
October 2005
End Date
November 2006
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility 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

Outcomes

Primary Outcomes

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 Outcomes

  • Changes in Laboratory Parameters(until Day 56)
  • Rates of Serious Adverse Events and Medically Attended Adverse Events(until Day 56)
  • SCR and GMT of Subjects With Concomitant Vaccinations(until Day 56)

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Safety and tolerability of the Japanese encephalitis vaccine IC51 (JE-PIV). Double blind, randomized, placebo controlled phase 3 study - IC51- 302Japanese encephalitis (JE) is the most common viral encephalitis, with over 50,000 cases reported annually. It is a considerable public health problem for many Asian countries (WHO 1997). Close to 3 billion people now live in regions at risk for the disease, particularly in rural areas where JE occurs sporadically in epidemics of variable magnitude. Vaccination against JE remains the single most important control measure worldwide.
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