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Clinical Trials/EUCTR2005-000253-29-AT
EUCTR2005-000253-29-AT
Active, not recruiting
Not Applicable

ONG TERM IMMUNOGENICITY OF THE JAPANESE ENCEPHALITIS VACCINEIC51 (JE-PIV). AN UNCONTROLLED PHASE 3 FOLLOW-UP STUDY - IC51-303

Intercell AG0 sites3,300 target enrollmentJuly 18, 2005
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Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
Intercell AG
Enrollment
3300
Status
Active, not recruiting
Last Updated
13 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
July 18, 2005
End Date
TBD
Last Updated
13 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •\-Subjects correctly included in and having completed clinical studies IC51\-301 or
  • •IC51\-302 with at least one vaccination.
  • •\-Written informed consent for study IC51\-303\.
  • •Only for the immunogenicity part:
  • •\-Subjects correctly included in and having completed study IC51\-301 or IC51\-302 according to the protocol with the required amount of injections (IC51\-301: 3 / IC51\-302: 2\).
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range
  • •F.1\.3 Elderly (\>\=65 years) yes

Exclusion Criteria

  • •\-Inability or unwillingness to provide informed consent and to abide by the requirements of the study.
  • •Only for the immunogenicity part:
  • •\-Known negative (\< 1:10\) anti\-JEV neutralizing antibody titer (PRNT) 28 days after the last vaccination in the preceding study or thereafter.
  • •\-Subjects with any condition which in the opinion of the Investigator makes the subject unsuitable for inclusion.
  • •\-Known randomization to JE\-VAX® or placebo

Outcomes

Primary Outcomes

Not specified

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