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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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ClinicalTrials.gov Identifier: NCT01900444
Recruitment Status : Completed
First Posted : July 16, 2013
Results First Posted : December 13, 2017
Last Update Posted : December 13, 2017
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

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® .

Condition or disease Intervention/treatment Phase
Japanese Encephalitis Biological: IMOJEV Phase 3

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  (Clinical Trial)
Actual Enrollment : 119 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Actual Study Start Date : July 11, 2013
Primary Completion Date : March 11, 2014
Study Completion Date : March 11, 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Encephalitis
U.S. FDA Resources

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 Name: Japanese Encephalitis Chimeric Virus Vaccine



Primary Outcome Measures :
  1. Percentage of Participants With JE Seroprotection Before and Following a Booster Dose of IMOJEV Given One Year After Primary Immunization [ Time Frame: Day 0 (pre-booster) and Day 28 post-booster injection ]
    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).

  2. Percentage of Participants With JE Seroconversion Following a Booster Dose of IMOJEV Given One Year After Primary Immunization [ Time Frame: Day 28 post-booster injection ]
    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.

  3. Summary of Geometric Mean Titers of JE Virus Antibodies Following a Booster Dose of IMOJEV Given One Year After Primary Immunization [ Time Frame: Day 0 (pre-booster) and Day 28 post-booster injection ]
    JE virus neutralizing antibodies were measured using PRNT50 test.

  4. Summary of Geometric Mean Titer Ratios of JE Virus Antibodies Following a Booster Dose of IMOJEV Given One Year After Primary Immunization [ Time Frame: Day 0 (pre-booster) and Day 28 post-booster injection ]
    JE virus neutralizing antibodies were measured using PRNT50.

  5. Percentage of Participants With JE Seroprotection Before and After a Booster Dose of IMOJEV Given At Different Intervals After Primary Immunization [ Time Frame: Day 0 (pre-booster) and Day 28 post-booster injection ]
    JE virus neutralizing antibodies were measured using PRNT50. Seroprotection was defined as neutralizing antibody titer ≥ 10 (1/dilution).

  6. Percentage of Participants With JE Seroconversion Following a Booster Dose of IMOJEV Given At Different Intervals After Primary Immunization [ Time Frame: Day 28 post-booster injection ]
    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.

  7. Summary of Geometric Mean Titers of JE Virus Antibodies Following a Booster Dose of IMOJEV At Different Intervals After Primary Immunization [ Time Frame: Day 0 (pre-booster) and Day 28 post-booster injection ]
    JE virus neutralizing antibodies were measured using PRNT50.

  8. Summary of Geometric Mean Titer Ratios of JE Virus Antibodies Following a Booster Dose of IMOJEV Given At Different Intervals After Primary Immunization [ Time Frame: Day 0 (pre-booster) and Day 28 post-booster injection ]
    JE virus neutralizing antibodies were measured using PRNT50.



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 4 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01900444


Locations
Korea, Republic of
Investigational Site 004
Gyeonggi-do, Korea, Republic of
Investigational Site 010
Gyeonggi-do, 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
Seoul, Korea, Republic of
Investigational Site 007
Wŏnju, Korea, Republic of
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
Study Director: Medical Director Sanofi Pasteur South Korea

Additional Information:
Responsible Party: Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier: NCT01900444     History of Changes
Other Study ID Numbers: JEC22
U1111-1127-7153 ( Other Identifier: WHO )
First Posted: July 16, 2013    Key Record Dates
Results First Posted: December 13, 2017
Last Update Posted: December 13, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data (IPD) and supporting clinical documents are available for request at clinicalstudydatarequest.com. While making information available, Sanofi continues to protect the privacy of the participants in clinical trials and to remove commercially confidential information (CCI). Details on Data Sharing criteria and process for requesting access can be found at this web address: clinicalstudydatarequest.com.

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

Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):
Japanese encephalitis
Japanese encephalitis chimeric virus vaccine
IMOJEV®

Additional relevant MeSH terms:
Encephalitis
Encephalitis, Japanese
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Encephalitis, Arbovirus
Arbovirus Infections
Virus Diseases
Encephalitis, Viral
Central Nervous System Viral Diseases
RNA Virus Infections
Flavivirus Infections
Flaviviridae Infections
Infectious Encephalitis
Central Nervous System Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs