Concomitant Vaccination With the Japanese Encephalitis Vaccine IC51 and HARVIX® 1440 - Full Text View

Sponsor:	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

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

Resource links provided by NLM:

MedlinePlus related topics: Encephalitis

U.S. FDA Resources

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

No publications provided

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

Additional relevant MeSH terms:

RNA Virus Infections
Flaviviridae Infections
Flavivirus Infections
Nervous System Diseases
Encephalitis, Japanese
Central Nervous System Diseases
Central Nervous System Viral Diseases

Brain Diseases
Encephalitis
Virus Diseases
Encephalitis, Viral
Central Nervous System Infections
Arbovirus Infections
Encephalitis, Arbovirus

ClinicalTrials.gov processed this record on November 27, 2009