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Long Term Persistence and Effect of a Booster Dose of the Japanese Encephalitis Vaccine IC51

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Intercell AG
ClinicalTrials.gov Identifier:
NCT00595270
First received: January 4, 2008
Last updated: October 18, 2012
Last verified: October 2012
History of Changes
  Purpose

The study investigates the long term persistence the Japanese encephalitis vaccine IC51 and the need of a booster dose


Condition Intervention Phase
Japanese Encephalitis
 Biological: IC51
 Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Long Term Persistence and Effect of a Booster Dose of the Japanese Encephalitis Vaccine IC51

Resource links provided by NLM:

MedlinePlus related topics: Encephalitis
U.S. FDA Resources

Further study details as provided by Intercell AG:

Primary Outcome Measures:
  • Long term immunogenicity of IC51 vaccine 24 months after the primary vaccination [ Time Frame: - 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Immunogenicity of IC51 vaccine 6 and 12 months after the primary vaccination [ Time Frame: - 6 months ] [ Designated as safety issue: No ]

Enrollment: 357
Study Start Date: October 2005
Study Completion Date: April 2009
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: IC51
6 mcg, i.m. injection,
 Biological: IC51
Other Name: Japanese Encephalitis purified inactivated vaccine

Detailed Description:

This is an open label, non‐randomized multi‐center phase 3 follow‐up study. All volunteers having completed trial IC51‐304 will be enrolled into this trial at 2 sites

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • At least 18 years of age
  • Written informed consent obtained prior to study entry
  • Subjects correctly included in and having completed study IC51-304 according to the protocol.

Exclusion Criteria:

  • Use of any other investigational or non-registered drug or vaccine in addition to the study vaccine during the study period
  • Immunodeficiency including post-organ-transplantation or immunosuppressive therapy
  • Pregnancy, lactation or unreliable contraception in female subjects
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00595270

Sponsors and Collaborators
Intercell AG
Investigators
Study Director: Susanne Eder Intercell AG
  More Information

No publications provided

Responsible Party: Intercell AG
ClinicalTrials.gov Identifier: NCT00595270     History of Changes
Other Study ID Numbers: IC51-305
Study First Received: January 4, 2008
Last Updated: October 18, 2012
Health Authority: Germany: Paul-Ehrlich-Institut
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

Additional relevant MeSH terms:
Encephalitis
Encephalitis, Japanese
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 May 19, 2013