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Completed

NCT Number: NCT01900444

Study of a Booster Dose of IMOJEV® 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® .

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Key information

Conditions

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

Age range

2 year–4 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Investigational Site 004, Gyeonggi-do, South Korea

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

IMOJEV

Biological

0.5 mL, Subcutaneous

Other names: Japanese Encephalitis Chimeric Virus Vaccine

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Sanofi Pasteur, a Sanofi Company

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jul 16, 2013
Registry last updated
Mar 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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