Safety and Tolerability of the Japanese Encephalitis Vaccine IC51 - Full Text View

Sponsored by:	Intercell AG
Information provided by:	Intercell AG
ClinicalTrials.gov Identifier:	NCT00605085

Purpose

The objective is to investigate the safety and tolerability of Japanese Encephalitis vaccine IC51 with an inactive control in healthy subjects aged > or = 18 years

Condition	Intervention	Phase
Japanese Encephalitis	Biological: Japanese Encephalitis purified inactivated vaccine (IC51) Biological: Placebo	Phase III

MedlinePlus related topics: Encephalitis

Drug Information available for: Sodium chloride Aluminum hydroxide Algeldrate Japanese Encephalitis Vaccines Aluminum

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety Study
Official Title:	Safety and Tolerability of the Japanese Encephalitis Vaccine IC51. Double Blind, Randomized, Placebo Controlled Phase 3 Study

Further study details as provided by Intercell AG:

Primary Outcome Measures:

Safety and tolerability of IC51 until 4 weeks after the last vaccination

Secondary Outcome Measures:

Rates of serious adverse events and medically attended adverse events

Enrollment:	2990
Study Start Date:	October 2005
Study Completion Date:	November 2006

Arms	Assigned Interventions
1: Experimental IC51	Biological: Japanese Encephalitis purified inactivated vaccine (IC51) IC51 (JE-PIV), 6 mcg, i.m. injection, 2 vaccinations, days 0 and 28
2: Placebo Comparator Placebo	Biological: Placebo Placebo: Phosphate-buffered saline (PBS) solution containing 0.1% aluminum hydroxide as an adjuvant, 0.5 mL, i.m. injection, 2 injections, days 0 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:

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
History of any previous JE vaccination (e.g. JE-VAX®)
Immunodeficiency including post-organ-transplantation or immunosuppressive therapy
A family history of congenital or hereditary immunodeficiency
History of autoimmune disease
Any acute infections within 2 weeks prior to enrollment
Known or suspected HIV Infection
Pregnancy, lactation or unreliable contraception in female subjects

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00605085

Sponsors and Collaborators

Intercell AG

Investigators

Study Director:

Astrid Kaltenboeck, Ph.D.

Intercell AG

More Information

Responsible Party:	Intercell AG
Study ID Numbers:	IC51-302
Study First Received:	January 4, 2008
Last Updated:	January 16, 2008
ClinicalTrials.gov Identifier:	NCT00605085
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

Arbovirus Infections
Brain Diseases
Encephalitis
Aluminum Hydroxide

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