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

Primary Purpose

Japanese Encephalitis

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
IMOJEV
Sponsored by
Sanofi Pasteur, a Sanofi Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Japanese Encephalitis focused on measuring Japanese encephalitis, Japanese encephalitis chimeric virus vaccine, IMOJEV®

Eligibility Criteria

2 Years - 4 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Investigational Site 004
  • Investigational Site 010
  • Investigational Site 001
  • Investigational Site 005
  • Investigational Site 006
  • Investigational Site 008
  • Investigational Site 009
  • Investigational Site 007

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

IMOJEV Group

Arm Description

Participants who received a single dose of IMOJEV in study JEC12 (NCT01396512) will receive a booster dose in this study.

Outcomes

Primary Outcome Measures

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).
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.
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.
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.
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).
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
July 11, 2013
Last Updated
March 21, 2022
Sponsor
Sanofi Pasteur, a Sanofi Company
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1. Study Identification

Unique Protocol Identification Number
NCT01900444
Brief Title
Study of a Booster Dose of IMOJEV® One Year After Primary Immunization in Healthy Children in South Korea
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
July 11, 2013 (Actual)
Primary Completion Date
March 11, 2014 (Actual)
Study Completion Date
March 11, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi Pasteur, a Sanofi Company

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
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® .
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Japanese Encephalitis
Keywords
Japanese encephalitis, Japanese encephalitis chimeric virus vaccine, IMOJEV®

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
119 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IMOJEV Group
Arm Type
Experimental
Arm Description
Participants who received a single dose of IMOJEV in study JEC12 (NCT01396512) will receive a booster dose in this study.
Intervention Type
Biological
Intervention Name(s)
IMOJEV
Other Intervention Name(s)
Japanese Encephalitis Chimeric Virus Vaccine
Intervention Description
0.5 mL, Subcutaneous
Primary Outcome Measure Information:
Title
Percentage of Participants With JE Seroprotection Before and Following a Booster Dose of IMOJEV Given One Year After Primary Immunization
Description
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).
Time Frame
Day 0 (pre-booster) and Day 28 post-booster injection
Title
Percentage of Participants With JE Seroconversion Following a Booster Dose of IMOJEV Given One Year After Primary Immunization
Description
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.
Time Frame
Day 28 post-booster injection
Title
Summary of Geometric Mean Titers of JE Virus Antibodies Following a Booster Dose of IMOJEV Given One Year After Primary Immunization
Description
JE virus neutralizing antibodies were measured using PRNT50 test.
Time Frame
Day 0 (pre-booster) and Day 28 post-booster injection
Title
Summary of Geometric Mean Titer Ratios of JE Virus Antibodies Following a Booster Dose of IMOJEV Given One Year After Primary Immunization
Description
JE virus neutralizing antibodies were measured using PRNT50.
Time Frame
Day 0 (pre-booster) and Day 28 post-booster injection
Title
Percentage of Participants With JE Seroprotection Before and After a Booster Dose of IMOJEV Given At Different Intervals After Primary Immunization
Description
JE virus neutralizing antibodies were measured using PRNT50. Seroprotection was defined as neutralizing antibody titer ≥ 10 (1/dilution).
Time Frame
Day 0 (pre-booster) and Day 28 post-booster injection
Title
Percentage of Participants With JE Seroconversion Following a Booster Dose of IMOJEV Given At Different Intervals After Primary Immunization
Description
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.
Time Frame
Day 28 post-booster injection
Title
Summary of Geometric Mean Titers of JE Virus Antibodies Following a Booster Dose of IMOJEV At Different Intervals After Primary Immunization
Description
JE virus neutralizing antibodies were measured using PRNT50.
Time Frame
Day 0 (pre-booster) and Day 28 post-booster injection
Title
Summary of Geometric Mean Titer Ratios of JE Virus Antibodies Following a Booster Dose of IMOJEV Given At Different Intervals After Primary Immunization
Description
JE virus neutralizing antibodies were measured using PRNT50.
Time Frame
Day 0 (pre-booster) and Day 28 post-booster injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
4 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Sanofi Pasteur South Korea
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site 004
City
Gyeonggi-do
Country
Korea, Republic of
Facility Name
Investigational Site 010
City
Gyeonggi-do
Country
Korea, Republic of
Facility Name
Investigational Site 001
City
Seoul
Country
Korea, Republic of
Facility Name
Investigational Site 005
City
Seoul
Country
Korea, Republic of
Facility Name
Investigational Site 006
City
Seoul
Country
Korea, Republic of
Facility Name
Investigational Site 008
City
Seoul
Country
Korea, Republic of
Facility Name
Investigational Site 009
City
Seoul
Country
Korea, Republic of
Facility Name
Investigational Site 007
City
Wŏnju
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
Links:
URL
http://www.sanofipasteur.com
Description
Related Info

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

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