Purified Inactivated Japanese Encephalitis Vaccine

NCT04223037 | Unknown Phase 3 DMC

• 1 other identifier: 074201504
• Study Type: interventional
• Target: 1,050
• Locations: 1 country
• Sites: 1

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.

Conditions

Japanese Encephalitis Virus Disease

Keywords

Japanese Encephalitis Vaccine; Phase III Clinical Trial

Outcome Measures

Primary Outcomes (2)

• Local and systemic adverse reactions

  The main endpoint of safety observation was 30 days after 2 doses vaccination. If serious adverse reactions related to vaccines occur during the observation period, or the adverse reactions of grade 3 and above reached 10%, or three symptoms similar to grade 3 and above occur within 24 hours, the trial should be suspended and vaccine-related adverse reactions occurred. The death of the subjects will be terminated at any time. Follow up and collection of serious adverse events within 6 months after first dose immunization via close monitoring or diary card.

  Within 6 months after immunization

• Immunogenecity detected by plaque reduction neutralization test

  Blood samples were collected from all subjects before and 30 days after the whole course of immunization, and neutralizing antibody was detected by plaque reduction neutralization test.

  1 month after immunization

Study Arms (2)

Day 0，7 immunization shedule

ACTIVE COMPARATOR

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

Biological: Japanese Encephalitis Vaccine produced by IMBCAMS; Biological: Japanese Encephalitis Vaccine produced by Liaoning Chenda

Day 0，28 immunization shedule

EXPERIMENTAL

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

Biological: Japanese Encephalitis Vaccine produced by IMBCAMS

Interventions

Japanese Encephalitis Vaccine produced by IMBCAMS BIOLOGICAL

Dosage form: 0.5mL/vial

Day 0，28 immunization shedule; Day 0，7 immunization shedule

Japanese Encephalitis Vaccine produced by Liaoning Chenda BIOLOGICAL

Dosage form: 0.5mL/vial

Day 0，7 immunization shedule

Eligibility Criteria

• Age: 6 Months - 23 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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℃.

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese Academy of Medical Sciences: lead

Study Sites (1)

Disease prevention and control center of Inner Mongolia autonomous region

Hohhot, Inner Mongolia, 010031, China

Location

MeSH Terms

Conditions

Encephalitis, Japanese

Interventions

Japanese Encephalitis Vaccines

Condition Hierarchy (Ancestors)

Encephalitis, Arbovirus; Encephalitis, Viral; Central Nervous System Viral Diseases; Central Nervous System Infections; Infections; Infectious Encephalitis; Arbovirus Infections; Vector Borne Diseases; Mosquito-Borne Diseases; Virus Diseases; RNA Virus Infections; Flavivirus Infections; Flaviviridae Infections; Encephalitis; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neuroinflammatory Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Shaohong Yan

  Disease prevention and control center of Inner Mongolia autonomous region

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director， WHO Prequalification Department

Study Record Dates

• First Submitted: January 6, 2020
• First Posted: January 10, 2020
• Study Start: September 1, 2015
• Primary Completion: March 7, 2018
• Study Completion: December 31, 2022
• Last Updated: March 9, 2022

Record last verified: 2022-03

Locations

CN (1)