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Encephalitis, Japanese clinical trials

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NCT ID: NCT01158599 Completed - Clinical trials for Japanese Encephalitis

This is a Study to Assess the Safety and Immunogenicity of Ixiaro® (IC51) in an Elderly Population

Start date: June 2010
Phase: Phase 4
Study type: Interventional

This is an open-label, uncontrolled phase 4 study to assess the safety and immunogenicity of the Japanese encephalitis (JE) vaccine Ixiaro® (IC51) in an elderly population.

NCT ID: NCT01150942 Completed - Clinical trials for Japanese Encephalitis

Clinical Trial to Assess the Immunogenicity and Safety of the Vero Cell-derived JE Vaccine in Korea

Start date: August 2010
Phase: Phase 3
Study type: Interventional

To assess the immunogenicity and safety of the vero cell-derived inactivated JE vaccine in Korean healthy children aged 12~23 months

NCT ID: NCT01092507 Completed - Clinical trials for Japanese Encephalitis

A Study of Japanese Encephalitis Chimeric Virus Vaccine Compared With SA14-14-2 Vaccine in Infants and Toddlers

Start date: March 2010
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare a single dose of Japanese encephalitis (JE) chimeric virus vaccine (JE-CV) with a single dose of SA14-14-2 live vaccine as primary vaccination in infants and toddlers. Primary Objective: - To demonstrate the non-inferiority of the antibody response 28 days after vaccine administration of one dose of JE CV (administered on Day 0) compared to the antibody response after one dose of the SA14-14-2 control vaccine (administered on Day 0). Secondary Objectives: - To describe the immune response to JE in both vaccine groups in JE-CV virus and SA14-14-2 virus before and after a single dose of JE CV or a single dose of SA14-14-2 vaccine - To describe the safety profile in all vaccinated subjects up to 28 days and all serious adverse events (SAEs) up to 6 months after vaccination. - To describe only related SAEs and all death from 6 month to 12-month follow-up.

NCT ID: NCT01047839 Completed - Encephalitis Clinical Trials

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

Start date: January 2010
Phase: Phase 3
Study type: Interventional

The primary objective is to assess the safety profile of IC51 in a pediatric population from regions where JEV is not endemic

NCT ID: NCT01041573 Completed - Encephalitis Clinical Trials

Safety and Immunogenicity of the Japanese Encephalitis Vaccine IC51 (IXIARO®) in a Pediatric Population

Start date: March 2010
Phase: Phase 3
Study type: Interventional

The primary objective is to assess the systemic and local safety profile of purified inactivated Japanese Encephalitis Virus (JEV) vaccine IC51 administered in two doses in a 28 days interval up to Month 7 after the first IC51 vaccination in a pediatric population from endemic regions.

NCT ID: NCT01001988 Completed - Clinical trials for Japanese Encephalitis

Long-term Follow-up of Immunogenicity of a Single Dose of Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) in Toddlers

Start date: August 7, 2009
Phase: Phase 3
Study type: Interventional

This is a long-term follow-up of the persistence of immune response in participants who previously received a single dose of JE-CV at age 12 to 18 months in Study JEC02 (NCT00735644) . No vaccination was administered during the present long-term follow-up study. Primary Objective: - To describe the yearly persistence of humoral immune response to Japanese encephalitis after a single dose of JE-CV

NCT ID: NCT00982137 Completed - Clinical trials for Japanese Encephalitis

Study of Live Attenuated Japanese Encephalitis Vaccine (ChimeriVax™-JE) and Yellow Fever Vaccine (STAMARIL®)

Start date: July 2004
Phase: Phase 2
Study type: Interventional

The purpose of this study is to obtain safety, tolerability, and immunogenicity data on the co-administration or sequential administration of Chimeravax™-JE vaccine and STAMARIL®. Objectives: Safety: - Obtain safety and tolerability data of a single, fixed dose of ChimeriVax™-JE administered concurrently, one month before or one month after STAMARIL® to adult volunteers (≥ 18 to ≤ 55 years) without prior Japanese encephalitis (JE) or yellow fever (YF) vaccination. Immunogenicity: - Obtain data on the antibody response to a single, fixed dose of ChimeriVax™-JE administered concurrently, one month before or one month after STAMARIL® to adult volunteers without prior JE (or YF) vaccination. - Assess the durability of the immune response in adult volunteers 6 months after administration of ChimeriVax™-JE and STAMARIL®.

NCT ID: NCT00981630 Completed - Clinical trials for Japanese Encephalitis

Study of Live Attenuated ChimeriVax™-Japanese Encephalitis Vaccine

Start date: November 2004
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the safety, tolerability, and immunogenicity of a new formulation of lyophilised ChimeriVax™-JE, given at three dose levels, compared with placebo. Primary Objectives: Safety: - To obtain safety and tolerability data for a single subcutaneous vaccination with ChimeriVax™-JE, at three dose levels, in healthy adult volunteers (18-49 years old). Immunogenicity: - To obtain data on the antibody response to a single subcutaneous vaccination with ChimeriVax™-JE, at three dose levels, in healthy adult volunteers without prior Japanese encephalitis immunity. - To assess the durability of immune response up to 12 months following a single subcutaneous vaccination with ChimeriVax™-JE, at three dose levels.

NCT ID: NCT00981175 Completed - Clinical trials for Japanese Encephalitis

A Study of ChimeriVax™-JE Live Attenuated Vaccine in Healthy Adults

Start date: April 2003
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the safety, tolerability, immunogenicity, and duration of immunity of one or two doses of ChimeriVax™-JE vaccine separated by 5 or 6 months in adults. Objectives: Safety: - Obtain safety and tolerability data of a single, fixed dose of ChimeriVax™-JE compared with a placebo in adult volunteers (≥ 18 to <55 years) without prior Japanese encephalitis (JE) vaccination. Immunogenicity: - Obtain data on the antibody response in adult volunteers following administration of ChimeriVax™-JE - Assess the durability of the immune response in adult volunteers over 60 months following one or two doses of ChimeriVax™-JE.

NCT ID: NCT00776230 Completed - Clinical trials for Japanese Encephalitis

Immunogenicity of a Commercial Batch of JEV IC51 up to 24 Months Post Filling

Start date: September 2008
Phase: Phase 3
Study type: Interventional

The objective is to assess immunogenicity of a commercial IC51 batch at 3 different time points post filling (12, 18, 24 months) in terms of Geometric Mean Titers (GMT) for anti-JEV neutralizing antibodies at Day 56 after the first vaccination.