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OpenTrials
Completed

NCT Number: NCT00595309

Effect of a Booster Dose of the Japanese Encephalitis Vaccine IC51

The objective is to assess the effect of a booster vaccination on immunogenicity of IC51 in terms of seroconversion rate.

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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

Primary location

Medizinische Universität Wien, Universitätsklinik für Klinische Pharmakologie, Vienna, Austria

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Who can participate

Healthy volunteers accepted: Yes

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

Main Inclusion Criteria:

  • Healthy adults who completed the primary immunization in study IC51 309
  • Male and female healthy subjects aged at least 18 years with written informed consent and either no childbearing potential or negative pregnancy test

Main Exclusion Criteria:

  • History of immunodeficiency or immunosuppressive therapy, known Human Immunodeficiency Virus (HIV), or drug addiction including alcohol dependence

Treatment and study plan

IC51

Biological

IC51, 6 mcg, intramuscular (i.m.) booster vaccination 15 months after the primary immunization

Primary outcomes

  1. Seroconversion Rate

    Time frame: at Month 12 after booster

Secondary outcomes

  1. Safety and Adverse Events

    Time frame: up to Month 12 after booster

  2. Seroconversion

    Time frame: at D28 and Month 6 after booster

  3. Geometric Mean Titer

    Time frame: D28, Month 6 and Month 12 after booster

Sponsors and collaborators

Lead sponsor

Valneva Austria GmbH

Industry

Registry information

Official study title

Effect of a Booster Dose of the Japanese Encephalitis Vaccine IC51 on Long Term Immunogenicity. An Uncontrolled, Open-label Phase 3 Study.

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Jan 16, 2008
Registry last updated
May 16, 2014

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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