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Japanese Encephalitis clinical trials

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NCT ID: NCT00595309 Completed - Clinical trials for Japanese Encephalitis

Effect of a Booster Dose of the Japanese Encephalitis Vaccine IC51

Start date: December 2007
Phase: Phase 3
Study type: Interventional

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

NCT ID: NCT00595270 Completed - Clinical trials for Japanese Encephalitis

Long Term Persistence and Effect of a Booster Dose of the Japanese Encephalitis Vaccine IC51

Start date: October 2005
Phase: Phase 3
Study type: Interventional

The study investigates the long term persistence the Japanese encephalitis vaccine IC51 and the need of a booster dose

NCT ID: NCT00594958 Completed - Clinical trials for Japanese Encephalitis

Comparison of Three Batches of the Japanese Encephalitis Vaccine IC51

Start date: September 2006
Phase: Phase 3
Study type: Interventional

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

NCT ID: NCT00463684 Completed - Clinical trials for Japanese Encephalitis

Live Attenuated Japanese Encephalitis (JE) Vaccine Coadministered With Measles Vaccine in Infants 9 Months of Age

JEV03
Start date: July 7, 2007
Phase: Phase 4
Study type: Interventional

To facilitate introduction of live attenuated SA 14-14-2 Japanese encephalitis vaccine (LJEV) into the National Immunization Programme of Sri Lanka, we evaluated the safety and immunogenicity of co-administration of LJEV and measles vaccine at 9 months of age. The primary hypothesis was that the seropositivity rate at 28 days post vaccination in Japanese Encephalitis (JE) and measles concomitantly vaccinated subjects 9 months of age is greater than 80% for JE and greater than 90% for measles.

NCT ID: NCT00463476 Completed - Clinical trials for Japanese Encephalitis

Boosterability of Live Attenuated Japanese Encephalitis (JE) Vaccine in Children Who Have Previously Received Inactivated JE Vaccine

Start date: July 9, 2007
Phase: Phase 4
Study type: Interventional

To facilitate introduction of live attenuated SA 14-14-2 Japanese encephalitis vaccine (LJEV) into the National Immunization Programme of Sri Lanka, we evaluated the safety and immunogenicity of co-administration of LJEV and measles vaccine in children at 2 and 5 years of age. The primary hypothesis was that the seropositivity rate at 28 days post vaccination of SA 14-14-2 in subjects 2 and 5 years of age who have already received at least two doses of mouse brain-derived inactivated JE vaccine is greater than 80%. Japanese encephalitis virus is the leading cause of viral neurological disease and disability in Asia. The severity of sequelae, together with the volume of cases, make JE the most important cause of viral encephalitis in the world. Approximately 3 billion people—including 700 million children—live in areas at risk in Asia for JE. JE most commonly infects children between the ages of 1 and 15 years, and can also infect adults in areas where the virus is newly introduced. More than 50,000 cases are reported annually and cause an estimated 10,000 to 15,000 deaths. This figure is believed to represent only a small proportion of the disease burden that actually exists.

NCT ID: NCT00441259 Completed - Clinical trials for Japanese Encephalitis

Safety and Efficacy Study of ChimeriVax™-JE and JE Inactivated Mouse Brain Vaccine in Children of Descending Age

Start date: January 2007
Phase: Phase 2
Study type: Interventional

This randomised, double-blind study is to be conducted on 96 subjects at multiple sites in India. Subjects will be enrolled by age group and randomised to either ChimeriVax™-JE (JE-CV) or JE Mouse Brain Derived Vaccine (JE-MBDV). Study consists of a screening period, a treatment period and a 2 year follow-up period. Primary safety endpoints will be the adverse event (AE) rates 28 days after completion of vaccination course. The primary efficacy endpoints will be the rate of seroconversion 28 days after completing vaccination.

NCT ID: NCT00319592 Completed - Clinical trials for Japanese Encephalitis

A Safety and Efficacy Study of Two Japanese Encephalitis Vaccines ChimeriVaxTM-JE and JE-VAX

Start date: May 2005
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine non-inferiority in seroconversion and to compare the safety and tolerability between ChimeriVax™-JE and JE-VAX® to the respective homologous virus strain and several wild types strains after completion of vaccination course.

NCT ID: NCT00314145 Completed - Clinical trials for Japanese Encephalitis

A Safety and Efficacy Study of Two Japanese Encephalitis Vaccines ChimeriVax™-JE and JE-VAX

Start date: November 2005
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine non-inferiority in seroconversion and to compare the safety and tolerability between ChimeriVaxTM-JE and JE-VAX to the respective homologous virus strain after completion of vaccination course.

NCT ID: NCT00314132 Completed - Clinical trials for Japanese Encephalitis

Safety Study of ChimeriVax™-JE Vaccine to Prevent Japanese Encephalitis.

Start date: October 2005
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess whether ChimeriVax™ JE vaccine (a new vaccine to be used for vaccination against Japanese encephalitis) is safe and well tolerated when compared to placebo (dummy) vaccination.

NCT ID: NCT00216268 Recruiting - Clinical trials for Japanese Encephalitis

Treatment of Japanese Encephalitis

Start date: July 2005
Phase: Phase 2
Study type: Interventional

Japanese encephalitis is the single largest cause of viral encephalitis in the world today. It occurs in yearly post monsoon outbreaks in Uttar Pradesh and other parts of India and south east Asia. There is presently no antiviral drug of proven benefit for this illness and treatment is mostly supportive. The drug Ribavirin is already in the market in use for other indications. It has been found useful in West Nile encephalitis and various hemorrhagic fevers caused by related arboviruses. This is a double blind placebo of Ribavirin in Japanese encephalitis. To the best of our knowledge, this is the first such trial in the world. The study hypothesis is that children treated with ribavirin will be no different from those getting placebo in terms of mortality, length of hospital stay, days to return to consciousness and oral feeds, days to become afebrile and convulsion free and in 3 month sequelae rate.