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Longterm Immunogenicity of the Japanese Encephalitis Vaccine IC51

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00596102
First Posted: January 16, 2008
Last Update Posted: July 30, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Valneva Austria GmbH
  Purpose
The study investigates the long term safety and immunogenicity of the Japanese Encephalitis vaccine IC51 up to month 60.

Condition Intervention Phase
Japanese Encephalitis Biological: Japanese Encephalitis purified inactivated vaccine Phase 3

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Longterm Immunogenicity of the Japanese Encephalitis Vaccine IC51. An Uncontrolled Phase 3 Follow-up Study

Resource links provided by NLM:


Further study details as provided by Valneva Austria GmbH:

Primary Outcome Measures:
  • Percentage of Subjects With Seroconversion Rate (SCR) ≥ 1:10 Anti-JEV Neutralizing Antibody Titer (PRNT) [ Time Frame: 24 months after the first vaccination ]
    first vaccination refers to 1st vaccine administration in studies IC51-301 or IC51-302


Secondary Outcome Measures:
  • Percentage of Subjects With Seroconversion Rate (SCR) ≥ 1:10 Anti-JEV Neutralizing Antibody Titer (PRNT) [ Time Frame: 6, 12, 36, 48 and 60 months after 1st vaccination ]
  • Geometric Mean Titers [ Time Frame: 6, 12, 36, 48 and 60 months ]
  • Adverse Events [ Time Frame: 6, 12, 24, 36, 48 and 60 months after 1st vaccination ]

Enrollment: 3258
Study Start Date: October 2005
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: Japanese Encephalitis purified inactivated vaccine
    Japanese Encephalitis purified inactivated vaccine
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Approximately 3,300 subjects having completed IC51, JE-VAX or placebo treatment in studies IC51-301 or IC51-302 will take part in the safety follow up, up to month 6 after 1st vaccination in the study IC51-301 (NCT00604708) or IC51-302 (NCT00605085).

Only ~160 subjects, who have been treated with IC51 will take part in the immunogenicity and long-term analysis up to month 60.

Criteria

Inclusion Criteria:

  • Healthy subjects at least 18 years of age
  • Written informed consent obtained prior to study entry
  • Subjects correctly included and having completed clinical studies IC51-301 (NCT00604708) and IC51-302 (NCT00605085) with at least one vaccination

Exclusion Criteria:

  • Inability or unwillingness to provide informed consent and to abide the requirements of the study
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00596102


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

Responsible Party: Valneva Austria GmbH
ClinicalTrials.gov Identifier: NCT00596102     History of Changes
Other Study ID Numbers: IC51-303
First Submitted: January 4, 2008
First Posted: January 16, 2008
Results First Submitted: November 14, 2013
Results First Posted: July 30, 2014
Last Update Posted: July 30, 2014
Last Verified: June 2014

Additional relevant MeSH terms:
Encephalitis
Encephalitis, Japanese
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Encephalitis, Arbovirus
Arbovirus Infections
Virus Diseases
Encephalitis, Viral
Central Nervous System Viral Diseases
RNA Virus Infections
Flavivirus Infections
Flaviviridae Infections
Infectious Encephalitis
Central Nervous System Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs