Skip to main content
OpenTrials
Completed

NCT Number: NCT00605085

Safety and Tolerability of the Japanese Encephalitis Vaccine IC51

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Japanese Encephalitis Arbovirus Infections Brain Diseases Central Nervous System Diseases Central Nervous System Infections Central Nervous System Viral Diseases Encephalitis Encephalitis, Arbovirus Encephalitis, Japanese Encephalitis, Viral Flaviviridae Infections Flavivirus Infections Infections Infectious Encephalitis Mosquito-Borne Diseases Nervous System Diseases Neuroinflammatory Diseases RNA Virus Infections Vector Borne Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Japanese Encephalitis purified inactivated vaccine (IC51)

Biological

IC51 (JE-PIV), 6 mcg, i.m. injection, 2 vaccinations, days 0 and 28

Placebo

Biological

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Valneva Austria GmbH

Industry

Registry information

Official study title

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

Important dates

Study start
2005
Study completion
2006
First posted
Jan 30, 2008
Registry last updated
Mar 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.