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Completed

NCT Number: NCT00604708

Immunogenicity Study of the Japanese Encephalitis Vaccine IC51

The objective is to demonstrate the non-inferiority of the Japanese Encephalitis vaccine IC51 compared to JE-VAX in healthy subjects aged > or = 18 years

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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

  • 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

Treatment and study plan

IC51

Biological

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

Other names: Japanese Encephalitis purified inactivated vaccine

JE-VAX

Biological

JE-VAX, 1mL s.c. injection, 3 vaccinations, days 0, 7 and 28

Primary outcomes

  1. SCR (Seroconversion Rate)of IC51 Compared to JE-VAX at Day 56

    Time frame: Day 56

    SCR: anti-JEV neutralizing antibody titer ≥1:10

  2. GMT (Geometric Mean Titer) of IC51 Compared to JE-VAX at Day 56

    Time frame: Day 56

    GMT: geometric mean of PRNT50

Secondary outcomes

  1. Safety and Adverse Events

    Time frame: until Day 56

  2. Immunogenicity at Day 28

    Time frame: Day 28

  3. Immunogenicity at Day 56 for North America vs. Europe

    Time frame: Day 56

  4. Immunogenicity at Day 56 for Subjects Older vs. Younger Than 50 Years of Age

    Time frame: Day 56

Sponsors and collaborators

Lead sponsor

Valneva Austria GmbH

Industry

Registry information

Official study title

Observer Blinded, Randomized Phase 3 Study to Investigate the Non-Inferiority of IC51 vs. JE-VAX as Vaccines for Japanese Encephalitis in Healthy Subjects

Important dates

Study start
2005
Primary completion
2006
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.

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