NCT04223037

Purified Inactivated Japanese Encephalitis Vaccine

Phase III Clinical Trial of Purified Inactivated Japanese Encephalitis Vaccine

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,050 (actual)
• Sponsor: Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 6 Months – 23 Months
• Healthy volunteers: Accepted

Summary

This study evaluates the immunogenicity and safety of a purified inactivated JE vaccine compared to a commercialized JE vaccine. In this phase III, randomized, blind trial, infants at 6-23 months of age were randomly assigned to three groups to receive experimental vaccine or control vaccine with two different vaccination schedule respectively.

Detailed description

The clinical study used randomized, blind method, commercialize inactivated Japanese encephalitis vaccine as control. In Infants at 6-23 months of age were injected with experimental vaccine with 0,7 days and 0,28 days vaccination schedule to evaluate immunogenicity and safety of the experimental vaccine and the effectiveness of different vaccination schedule. Participates were assigned to three groups (350 per group): group 1 with experimental vaccine using 0,7 days vaccination schedule; group 2 with control vaccine using 0, 7 days vaccination schedule; group 3 with experimental vaccine using 0, 28 vaccination schedule. Blood samples were collected before immunization and 30 days after immunization, and the neutralization antibody of Japanese encephalitis was detected by plaque reduction neutralization test. Medical observation was conducted 30 minutes after each injection. Body temperature of participates was continuously measured for 7 days, and any adverse events were observed and recorded from the first dose to 30 days after the whole vaccination. Serious adverse events were collected within 6 months after the first dose.

Conditions

• Japanese Encephalitis Virus Disease

Interventions

Type	Name	Description
BIOLOGICAL	Japanese Encephalitis Vaccine produced by IMBCAMS	Dosage form: 0.5mL/vial
BIOLOGICAL	Japanese Encephalitis Vaccine produced by Liaoning Chenda	Dosage form: 0.5mL/vial

Timeline

• Start date: 2015-09-01
• Primary completion: 2018-03-07
• Completion: 2022-12-31
• First posted: 2020-01-10
• Last updated: 2022-03-09

Locations

1 site across 1 country: China