Purified Inactivated Japanese Encephalitis Vaccine

NCT ID: NCT04223037

Last Updated: 2022-03-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 1050 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-01
• Study Completion Date: 2022-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Day 0，7 immunization shedule

Japanese Encephalitis Vaccine produced by Institute of Medical Biology, Chinese Academy of Medical Sciences (IMBCAMS) and Japanese Encephalitis Vaccine produced by Liaoning Chenda CO.,LTD Dosage form: 0.5mL/vial Two Dose injection with 7 days interval

Group Type: ACTIVE_COMPARATOR

Japanese Encephalitis Vaccine produced by IMBCAMS

Intervention Type: BIOLOGICAL

Dosage form: 0.5mL/vial

Japanese Encephalitis Vaccine produced by Liaoning Chenda

Intervention Type: BIOLOGICAL

Dosage form: 0.5mL/vial

Day 0，28 immunization shedule

Japanese Encephalitis Vaccine produced by IMBCAMS Dosage form: 0.5mL/vial Two Dose injection with 28 days interval

Group Type: EXPERIMENTAL

Japanese Encephalitis Vaccine produced by IMBCAMS

Intervention Type: BIOLOGICAL

Dosage form: 0.5mL/vial

Interventions

Japanese Encephalitis Vaccine produced by IMBCAMS

Dosage form: 0.5mL/vial

Intervention Type: BIOLOGICAL

Japanese Encephalitis Vaccine produced by Liaoning Chenda

Dosage form: 0.5mL/vial

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• 6-23 months old infants, no vaccination history of JE vaccine, no vaccination contraindication.
• informed consent of guardian / lawful written guardian, and signed informed consent;
• the guardian and family can comply with the requirements of the clinical trial scheme.
• there was no immunization history of immunoglobulins within three months, and there was no history of live vaccination within 14 days.
• the axillary temperature ≤ 37℃.

Exclusion Criteria

• Allergy to any ingredient in the vaccine (any previous history of vaccine allergy); There are allergic, convulsive, epileptic, encephalopathy and psychiatric symptoms or signs.
• People with known or suspected (or high-risk) impairment or abnormality of immune function, such as those receiving immunosuppressive or immunopotentiator therapy, receiving blood products or plasma extracts within three months, or having an immunodeficiency virus infection or related disease in the mother or child.
• A history of thrombocytopenia or other coagulation disorders clearly diagnosed by the medical department, or a history of hemorrhagic constitution or prolonged bleeding time;
• Infected patients with known or suspected to have respiratory diseases, acute infections or active chronic diseases and are receiving antibiotic or antiviral treatment;
• In the past 3 days, fever (axillary body temperature≥38℃), oral or steroid hormones were given.
• Infectious or allergic skin diseases.
• Participating in another clinical researcher; or any situation that the researcher considers likely to affect the evaluation of the trial

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 23 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chinese Academy of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Mingbo Sun

Director， WHO Prequalification Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shaohong Yan

Role: PRINCIPAL_INVESTIGATOR

Disease prevention and control center of Inner Mongolia autonomous region

Locations

Disease prevention and control center of Inner Mongolia autonomous region

Hohhot, Inner Mongolia, China

Countries

China

Other Identifiers

074201504

Identifier Type: -

Identifier Source: org_study_id