Trial record 18 of 56 for:    "Encephalitis, Japanese"

Longterm Immunogenicity of the Japanese Encephalitis Vaccine IC51

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Valneva Austria GmbH
ClinicalTrials.gov Identifier:
NCT00596102
First received: January 4, 2008
Last updated: June 27, 2014
Last verified: June 2014
  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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Geometric Mean Titers [ Time Frame: 6, 12, 36, 48 and 60 months ] [ Designated as safety issue: No ]
  • Adverse Events [ Time Frame: 6, 12, 24, 36, 48 and 60 months after 1st vaccination ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00596102

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

No publications provided

Responsible Party: Valneva Austria GmbH
ClinicalTrials.gov Identifier: NCT00596102     History of Changes
Other Study ID Numbers: IC51-303
Study First Received: January 4, 2008
Results First Received: November 14, 2013
Last Updated: June 27, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Encephalitis, Japanese
Encephalitis
Central Nervous System Viral Diseases
Virus Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Central Nervous System Infections
Encephalitis, Arbovirus
Arbovirus Infections
Encephalitis, Viral
RNA Virus Infections
Flavivirus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on August 18, 2014