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

Tracking Information

First Received Date ^ICMJE

January 4, 2008

Last Updated Date

January 15, 2008

Start Date ^ICMJE

September 2005

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Immunogenicity of IC51 2 months after the first vaccination and HAVRIX® 1440 1 month after the first vaccination

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00596271 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Rate of adverse events, serious adverse events and medically attended adverse events during the vaccination period until 6 months after the last vaccination

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Safety and Immunogenicity of Concomitant Vaccination With IC51 and HARVIX® 1440 in Healthy Subjects. A Single-Blind Randomized, Controlled Phase 3 Study

Brief Summary

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

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Safety Study

Condition ^ICMJE

Japanese Encephalitis

Intervention ^ICMJE

Biological: Japanese Encephalitis purified inactivated vaccine

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

192

Completion Date

May 2007

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00596271

Responsible Party

Intercell AG

Study ID Numbers ^ICMJE

IC51-308

Study Sponsor ^ICMJE

Intercell AG

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Astrid Kaltenboeck, Ph.D.

Intercell AG

Information Provided By

Intercell AG

Verification Date

March 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP