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

2014-08-27 03:39:52 | BioPortfolio

Summary

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

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Conditions

Japanese Encephalitis

Intervention

ChimeriVax(TM)-JE, Japanese Encephalitis Inactivated Mouse Brain Vaccine

Location

Dr Atul's Child Hospital
Jaipur
Rajasthan
India
302016

Status

Active, not recruiting

Source

Sanofi-Aventis

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:39:52-0400

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Medical and Biotech [MESH] Definitions

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).

A species of FLAVIVIRUS, one of the Japanese encephalitis virus group (ENCEPHALITIS VIRUSES, JAPANESE), which is the etiological agent of Japanese encephalitis found in Asia, southeast Asia, and the Indian subcontinent.

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 mosquito-borne encephalitis caused by the Japanese B encephalitis virus (ENCEPHALITIS VIRUS, JAPANESE) occurring throughout Eastern Asia and Australia. The majority of infections occur in children and are subclinical or have features limited to transient fever and gastrointestinal symptoms. Inflammation of the brain, spinal cord, and meninges may occur and lead to transient or permanent neurologic deficits (including a POLIOMYELITIS-like presentation); SEIZURES; COMA; and death. (From Adams et al., Principles of Neurology, 6th ed, p751; Lancet 1998 Apr 11;351(9109):1094-7)

Vaccines or candidate vaccines used to prevent infection with Japanese B encephalitis virus (ENCEPHALITIS VIRUS, JAPANESE).

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