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Concomitant Vaccination With the Japanese Encephalitis Vaccine IC51 and HARVIX® 1440

This study has been completed.

Sponsored by: Intercell AG
Information provided by: Intercell AG
ClinicalTrials.gov Identifier: NCT00596271
  Purpose

The objective is to investigate the immunogenicity of the Japanese Encephalitis vaccine IC51 (JE-PIV) single and concomitant with HAVRIX® 1440


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

MedlinePlus related topics:   Encephalitis   

ChemIDplus related topics:   Japanese Encephalitis Vaccines   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Prevention, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Safety Study
Official Title:   Safety and Immunogenicity of Concomitant Vaccination With IC51 and HARVIX® 1440 in Healthy Subjects. A Single-Blind Randomized, Controlled Phase 3 Study

Further study details as provided by Intercell AG:

Primary Outcome Measures:
  • Immunogenicity of IC51 2 months after the first vaccination and HAVRIX® 1440 1 month after the first vaccination

Secondary Outcome Measures:
  • Rate of adverse events, serious adverse events and medically attended adverse events during the vaccination period until 6 months after the last vaccination

Enrollment:   192
Study Start Date:   September 2005
Study Completion Date:   May 2007

  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
  • In female subjects either childbearing potential terminated by surgery or one year post-menopausal, or a negative serum pregnancy test during screening and the willingness not to become pregnant during the study period and 30 days after the last vaccination by practicing reliable methods of contraception
  • Written informed consent obtained prior to study entry

Exclusion Criteria:

  • History of clinical manifestation of any flavivirus infection
  • History of vaccination against Japanese encephalitis (JE), Yellow fever and Dengue fever (an anti-JEV neutralizing antibody titer >= 1:10 at baseline is acceptable for inclusion, these subjects will be part of the safety population, but will not be analyzed for immunogenicity in the per-protocol analysis)
  • History of any previous Hepatitis A vaccination and infection
  • Use of any other investigational or non-registered drug or vaccine in addition to the study vaccine during the study period or within 30 days preceding the first dose of study vaccine
  • Planned administration of another vaccine during the study period
  • Immunodeficiency including post-organ-transplantation or immunosuppressive therapy
  • A family history of congenital or hereditary immunodeficiency
  • History of autoimmune disease
  • Administration of chronic (defined as more than 14 days) immunosuppressants or other immune-modifying drugs within six months of vaccination.
  • Any acute infections within 4 weeks prior to enrollment
  • Infection with HIV, Hepatitis B (HBsAg) or Hepatitis C
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00596271

Sponsors and Collaborators
Intercell AG

Investigators
Study Director:     Astrid Kaltenboeck, Ph.D.     Intercell AG    
  More Information

Responsible Party:   Intercell AG
Study ID Numbers:   IC51-308
First Received:   January 4, 2008
Last Updated:   January 15, 2008
ClinicalTrials.gov Identifier:   NCT00596271
Health Authority:   Germany: Paul-Ehrlich-Institut;   Austria: Agency for Health and Food Safety;   United States: Food and Drug Administration

Study placed in the following topic categories:
Virus Diseases
Japanese encephalitis
Central Nervous System Infections
Central Nervous System Diseases
Encephalitis, Japanese
Healthy
Arbovirus Infections
Brain Diseases
Encephalitis

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

ClinicalTrials.gov processed this record on September 05, 2008




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