Immunogenicity Study of the Japanese Encephalitis Vaccine IC51 - Full Text View

Sponsored by:	Intercell AG
Information provided by:	Intercell AG
ClinicalTrials.gov Identifier:	NCT00604708

Purpose

The objective is to demonstrate the non-inferiority of the Japanese Encephalitis vaccine IC51 compared to JE-VAX in healthy subjects aged > or = 18 years

Condition	Intervention	Phase
Japanese Encephalitis	Biological: Japanese Encephalitis purified inactivated vaccine (IC51) Biological: JE-VAX	Phase III

MedlinePlus related topics: Encephalitis

Drug Information available for: Japanese Encephalitis Vaccines

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Observer Blinded, Randomized Phase 3 Study to Investigate the Non-Inferiority of IC51 vs. JE-VAX as Vaccines for Japanese Encephalitis in Healthy Subjects

Further study details as provided by Intercell AG:

Primary Outcome Measures:

Immunogenicity of IC51 compared to JE-VAX 4 weeks after the last vaccination

Secondary Outcome Measures:

Safety and Adverse Events

Enrollment:	1271
Study Start Date:	September 2005
Study Completion Date:	September 2006

Arms	Assigned Interventions
1: Experimental IC51 (JE-PIV)	Biological: Japanese Encephalitis purified inactivated vaccine (IC51) IC51 (JE-PIV), 6 mcg, i.m. injection, 2 vaccinations, days 0 and 28
2: Active Comparator JE-VAX	Biological: JE-VAX JE-VAX, 1mL s.c. injection, 3 vaccinations, days 0, 7 and 28

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

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)
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
Immunodeficiency including post-organ-transplantation or immunosuppressive therapy
A family history of congenital or hereditary immunodeficiency
History of autoimmune disease
Any acute infections within 4 weeks prior to enrollment
Infection with HIV, Hepatitis B or Hepatitis C
Pregnancy, lactation or unreliable contraception in female subjects

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00604708

Sponsors and Collaborators

Intercell AG

Investigators

Study Director:

Astrid Kaltenboeck, Ph.D.

Intercell AG

More Information

Responsible Party:	Intercell AG
Study ID Numbers:	IC51-301
Study First Received:	January 4, 2008
Last Updated:	January 16, 2008
ClinicalTrials.gov Identifier:	NCT00604708
Health Authority:	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 January 14, 2009