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Concomitant Vaccination With the Japanese Encephalitis Vaccine IC51 and HARVIX® 1440 | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

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

NCT00596271•Valneva Austria GmbH

View on ClinicalTrials.gov

Summary

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

Detailed Description

This is a randomized, controlled, multi-center, single-blind phase 3 study. The study population consists of male and female healthy subjects, aged at least 18 years. 192 subjects will be enrolled at 2 sites in Europe.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

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
+1 more criteria

Key Dates

Start Date

September 1, 2005

Primary Completion Date

July 1, 2006

Completion Date

August 1, 2008

Last Updated

May 13, 2014

Enrollment

192

ACTUAL participants

Conditions

Japanese Encephalitis

Interventions

IC51

BIOLOGICAL

HAVRIX

BIOLOGICAL

Placebo

OTHER

Safety Observation of the Japanese Encephalitis Vaccine Given With a Primary Immunization

NCT06372665

Japanese Encephalitis

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COMPLETEDPHASE3

Comparison of Three Batches of the Japanese Encephalitis Vaccine IC51

NCT00594958

Japanese Encephalitis

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UNKNOWNPHASE4

Seroprevalence of Neutralizing Antibodies Against Japanese Encephalitis Virus Among 6 Years Old Children With 5 Different Immunization Strategies in Zhejiang Province

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 13, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Safety Observation of the Japanese Encephalitis Vaccine Given With a Primary Immunization

Comparison of Three Batches of the Japanese Encephalitis Vaccine IC51

Seroprevalence of Neutralizing Antibodies Against Japanese Encephalitis Virus Among 6 Years Old Children With 5 Different Immunization Strategies in Zhejiang Province

Study of a Single Primary Dose Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) in Healthy Subjects

Safety of Vero Cell - Derived Inactivated Japanese Encephalitis Vaccine (JECEVAX) in Children From 9-24 Months of Age

Post-licensure Safety Study of IMOJEV® in Thailand