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Immunogenicity and Safety of the Japanese Encephalitis Vaccine IC51 (IXIARO®, JESPECT®) in a Pediatric Population in Non-endemic Countries

2014-07-23 21:11:09 | BioPortfolio

Summary

The primary objective is to assess immunogenicity of the purified inactivated Japanese Encephalitis (JE) vaccine IC51 using the Seroconversion rates (SCRs) and Geometric Mean Titers (GMTs) at Day 56 in a pediatric population from regions where JE is not endemic.

Study Design

Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Conditions

Encephalitis

Intervention

IC51, IC51, IC51

Location

Tampa Clinical Research Inc.
Tampa
Florida
United States
33624

Status

Recruiting

Source

Intercell AG

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:11:09-0400

Clinical Trials [84 Associated Clinical Trials listed on BioPortfolio]

Immunogenicity Study of the Japanese Encephalitis Vaccine IC51

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

Effect of a Booster Dose of the Japanese Encephalitis Vaccine IC51

The objective is to assess the effect of a booster vaccination on immunogenicity of IC51 in terms of seroconversion rate.

Long Term Immunity and Safety Following Vaccination With the JEV IC51 (IXIARO®, JESPECT®) in Pediatric Population In Non Endemic Countries. Uncontrolled, Ph3 FU-Study

The study investigates long-term immunity and safety of IC51 (IXIARO®, JESPECT®) in a pediatric population vaccinated in the parent study IC51-322.

Comparison of Three Commercial Batches of the Japanese Encephalitis Vaccine IC51

The objective is to demonstrate equivalence of three commercial IC51 batches in terms of geometric mean titers for anti-JEV neutralizing antibody

Comparison of Three Batches of the Japanese Encephalitis Vaccine IC51

The objective is to demonstrate equivalence of three IC51 batches in terms of Geometric Mean Titers for anti-JEV neutralizing antibody.

PubMed Articles [207 Associated PubMed Articles listed on BioPortfolio]

Anti-N-methyl-D-aspartate receptor encephalitis associated with acute Toxoplasma gondii infection: A case report.

Anti-N-methyl-D-aspartate receptor (NMDAR) encephalitis has been recognized as the most frequent autoimmune encephalitis in children. Several infectious agents have been implicated in anti-NMDA enceph...

Development of an improved RT-qPCR Assay for detection of Japanese encephalitis virus (JEV) RNA including a systematic review and comprehensive comparison with published methods.

Japanese encephalitis virus (JEV) is a major cause of encephalitis in Asia, and the commonest cause of mosquito-borne encephalitis worldwide. Detection of JEV RNA remains challenging due to the charac...

Acute encephalitis - diagnosis and management.

Encephalitis, inflammation of the brain, is most commonly caused by a viral infection (especially herpes simplex virus [HSV] type 1 in the UK) although autoimmune causes, such as N-methyl D-aspartate ...

LGI1 antibody encephalitis - Detailed clinical, laboratory and radiological description of 13 cases in China.

LGI1 antibody encephalitis is a synaptic autoimmune disorder that was first reported in 2010. To date, LGI1 antibody encephalitis is a widely-recognized disease in neurology and psychiatry. In order t...

Age-dependent susceptibility to reovirus encephalitis in mice is influenced by maturation of the type-I interferon response.

Infants and young children are particularly susceptible to viral encephalitis, but the mechanisms are unknown. We determined the age-dependent contribution of innate and adaptive immune functions to r...

Medical and Biotech [MESH] Definitions

A subgroup of the genus FLAVIVIRUS which comprises a number of viral species that are the etiologic agents of human encephalitis in many different geographical regions. These include Japanese encephalitis virus (ENCEPHALITIS VIRUS, JAPANESE), St. Louis encephalitis virus (ENCEPHALITIS VIRUS, ST. LOUIS), Murray Valley encephalitis virus (ENCEPHALITIS VIRUS, MURRAY VALLEY), and WEST NILE VIRUS.

A species of FLAVIVIRUS, one of the Japanese encephalitis virus group (ENCEPHALITIS VIRUSES, JAPANESE), found in Australia and New Guinea. It causes a fulminating viremia resembling Japanese encephalitis (ENCEPHALITIS, JAPANESE).

Encephalitis caused by neurotropic viruses that are transmitted via the bite of TICKS. In Europe, the diseases are caused by ENCEPHALITIS VIRUSES, TICK-BORNE, which give rise to Russian spring-summer encephalitis, central European encephalitis, louping ill encephalitis, and related disorders. Powassan encephalitis occurs in North America and Russia and is caused by the Powassan virus. ASEPTIC MENINGITIS and rarely encephalitis may complicate COLORADO TICK FEVER which is endemic to mountainous regions of the western United States. (From Joynt, Clinical Neurology, 1996, Ch26, pp14-5)

A species of FLAVIVIRUS, one of the Japanese encephalitis virus group (ENCEPHALITIS VIRUSES, JAPANESE), which is the etiologic agent of ST. LOUIS ENCEPHALITIS in the United States, the Caribbean, and Central and South America.

A serotype of the species California encephalitis virus (ENCEPHALITIS VIRUS, CALIFORNIA), in the genus ORTHOBUNYAVIRUS, causing human MENINGOENCEPHALITIS. This is the agent most responsible for California encephalitis (ENCEPHALITIS, CALIFORNIA), the most prevalent mosquito-borne disease recognized in the United States.

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Pediatrics is the general medicine of childhood. Because of the developmental processes (psychological and physical) of childhood, the involvement of parents, and the social management of conditions at home and at school, pediatrics is a specialty. With ...


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