Study of a Booster Dose of IMOJEV® One Year After Primary Immunization in Healthy Children in South Korea

Immunogenicity and Safety Exploration of a Booster Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) Given One Year After Primary Immunization in Healthy Children in South Korea

The aim of this study was to document the immunogenicity and safety of a booster dose of IMOJEV administered at least 12 months after the primary dose.

Primary objective:

• To describe the immune response to Japanese Encephalitis (JE) before and 28 days after a booster dose of IMOJEV administered at least 12 months after primary vaccination with IMOJEV.

Exploratory objectives:

• To describe the safety profile of a booster dose of IMOJEV® .

Study Overview

• Status: Completed
• Conditions: Japanese Encephalitis
• Intervention / Treatment: Biological: IMOJEV

Detailed Description

Participants who previously participated in Study JEC12 (NCT01396512) and were primed with IMOJEV received a booster dose of IMOJEV at least 12 months after the primary dose. Participants were assessed for immune response before and on Day 28 after the booster dose and were monitored for safety through Day 28 post-vaccination for non-serious adverse events (AEs) and up to 6 months post-vaccination for serious AEs The duration of each participant's participation in the study was approximately 6 months.

• Study Type: Interventional
• Enrollment (Actual): 119
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do, Korea, Republic of
    • Investigational Site 004
  • Gyeonggi-do, Korea, Republic of
    • Investigational Site 010
  • Seoul, Korea, Republic of
    • Investigational Site 001
  • Seoul, Korea, Republic of
    • Investigational Site 005
  • Seoul, Korea, Republic of
    • Investigational Site 006
  • Seoul, Korea, Republic of
    • Investigational Site 008
  • Seoul, Korea, Republic of
    • Investigational Site 009
  • Wŏnju, Korea, Republic of
    • Investigational Site 007

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 4 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Must have participated in study JEC12 and received 1 dose of IMOJEV at least 12 months before booster vaccination
• Age 2 to 4 years on the day of inclusion
• In good general health at the time of inclusion
• Informed Concent Form signed and dated by parent(s) or another legally acceptable representative(s)
• Subject and parent(s)/legally acceptable representative(s) able to attend all scheduled visits and comply with all study procedures.

Exclusion Criteria:

• Participation at the time of study enrollment (or in the 4 weeks preceding the trial vaccination) or planned participation during the present trial period in another clinical study investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the study vaccination
• Known or suspected congenital or acquired immunodeficiency, or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy
• Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances
• Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
• Receipt of immune globulins, blood or blood-derived products in the past 3 months, that might interfere with the assessment of the immune response
• Previous vaccination against flavivirus disease, including JE, with another vaccine, except with IMOJEV® while participating in JEC12
• Administration of any anti-viral within 2 months preceding Visit 1 and up to the 4 weeks following the study vaccination
• Receipt of any vaccine in the 4 weeks preceding the trial vaccination or planned receipt of any vaccine in the 4 weeks following the trial vaccination, except for inactivated influenza vaccination, which may be received at least 2 weeks before the study vaccine
• History of central nervous system disorder or disease, including seizures
• Planned receipt of any JE vaccine during the course of the study
• History of flavivirus infection (confirmed either clinically, serologically or virologically)
• Administration of systemic corticosteroids for more than 2 consecutive weeks within the 4 weeks preceding vaccination
• Thrombocytopenia, contraindicating vaccination
• Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating vaccination
• Febrile illness (temperature ≥38.0°C) or moderate or severe acute illness/infection 3 days before vaccination as well as the day of vaccination, according to Investigator judgment. A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided
• In an emergency setting or hospitalized involuntarily
• Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IMOJEV Group; Participants who received a single dose of IMOJEV in study JEC12 (NCT01396512) will receive a booster dose in this study.	Biological: IMOJEV; 0.5 mL, Subcutaneous; Other Names: Japanese Encephalitis Chimeric Virus Vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With JE Seroprotection Before and Following a Booster Dose of IMOJEV Given One Year After Primary Immunization	JE virus neutralizing antibodies were measured using a 50% plaque reduction neutralization test (PRNT50). Seroprotection status for antibody levels against JE virus before and after IMOJEV vaccination was defined as antibody titers ≥ 10 (1/dilution).	Day 0 (pre-booster) and Day 28 post-booster injection
Percentage of Participants With JE Seroconversion Following a Booster Dose of IMOJEV Given One Year After Primary Immunization	JE virus neutralizing antibodies were measured using PRNT50. Seroconversion was defined as a pre-vaccination titer <10 (1/dilution) and post-vaccination titer ≥10 (1/dilution, or pre-vaccination titer ≥10 (1/dilution) and a ≥4-fold increase of titers from pre- to post-vaccination.	Day 28 post-booster injection
Summary of Geometric Mean Titers of JE Virus Antibodies Following a Booster Dose of IMOJEV Given One Year After Primary Immunization	JE virus neutralizing antibodies were measured using PRNT50 test.	Day 0 (pre-booster) and Day 28 post-booster injection
Summary of Geometric Mean Titer Ratios of JE Virus Antibodies Following a Booster Dose of IMOJEV Given One Year After Primary Immunization	JE virus neutralizing antibodies were measured using PRNT50.	Day 0 (pre-booster) and Day 28 post-booster injection
Percentage of Participants With JE Seroprotection Before and After a Booster Dose of IMOJEV Given At Different Intervals After Primary Immunization	JE virus neutralizing antibodies were measured using PRNT50. Seroprotection was defined as neutralizing antibody titer ≥ 10 (1/dilution).	Day 0 (pre-booster) and Day 28 post-booster injection
Percentage of Participants With JE Seroconversion Following a Booster Dose of IMOJEV Given At Different Intervals After Primary Immunization	JE virus neutralizing antibodies were measured using PRNT50. Seroconversion was defined as a pre-vaccination titer <10 (1/dilution) and post-vaccination titer ≥10 (1/dilution, or pre-vaccination titer ≥10 (1/dilution) and a ≥4 fold increase from pre- to post-vaccination.	Day 28 post-booster injection
Summary of Geometric Mean Titers of JE Virus Antibodies Following a Booster Dose of IMOJEV At Different Intervals After Primary Immunization	JE virus neutralizing antibodies were measured using PRNT50.	Day 0 (pre-booster) and Day 28 post-booster injection
Summary of Geometric Mean Titer Ratios of JE Virus Antibodies Following a Booster Dose of IMOJEV Given At Different Intervals After Primary Immunization	JE virus neutralizing antibodies were measured using PRNT50.	Day 0 (pre-booster) and Day 28 post-booster injection

Collaborators and Investigators

• Sponsor: Sanofi Pasteur, a Sanofi Company
• Investigators: Study Director: Medical Director, Sanofi Pasteur South Korea

Publications and helpful links

Helpful Links

• Related Info
• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): July 11, 2013
• Primary Completion (Actual): March 11, 2014
• Study Completion (Actual): March 11, 2014

Study Registration Dates

• First Submitted: July 11, 2013
• First Submitted That Met QC Criteria: July 11, 2013
• First Posted (Estimate): July 16, 2013

Study Record Updates

• Last Update Posted (Actual): March 28, 2022
• Last Update Submitted That Met QC Criteria: March 21, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Japanese encephalitis; IMOJEV®; Japanese encephalitis chimeric virus vaccine
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; RNA Virus Infections; Virus Diseases; Infections; Encephalitis, Arbovirus; Encephalitis, Viral; Central Nervous System Viral Diseases; Central Nervous System Infections; Infectious Encephalitis; Arbovirus Infections; Vector Borne Diseases; Flavivirus Infections; Flaviviridae Infections; Encephalitis, Japanese; Encephalitis; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: JEC22; U1111-1127-7153 (Other Identifier: WHO)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes