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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT01900444
First received: July 11, 2013
Last updated: January 14, 2014
Last verified: January 2014
  Purpose

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

Primary objective:

  • To describe the immune response to Japanese Encephalitis (JE) before (Day 0) and 28 days (Day 28) after a booster dose of IMOJEV® administered at least 1 year after primary vaccination with IMOJEV®.

Exploratory objectives:

  • To test the non-inferiority of IMOJEV® versus previous data obtained in the JEC15 study (NCT01190228) with the same product in terms of seroprotection rate 28 days after booster vaccination.
  • To describe the safety profile of a booster dose of IMOJEV® .

Condition Intervention Phase
Japanese Encephalitis
Biological: IMOJEV®: Live Attenuated Japanese Encephalitis Chimeric Virus
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Summary of the Neutralizing antibody titers at baseline and following booster vaccination [ Time Frame: 28 Days Post vaccination ] [ Designated as safety issue: No ]
    The presence of neutralizing antibodies will be measured using a Japanese encephalitis chimeric virus (IMOJEV®) 50% Plaque Reduction Neutralization Test (PRNT50) assay

  • Number of participants with seroconversion following a booster dose of IMOJEV® vaccination [ Time Frame: 28 Days post booster vaccination ] [ Designated as safety issue: No ]
    Seroconversion defined by JE virus neutralizing antibody titers ≥ 10 (1/dil) in subjects who are seronegative at baseline (< 10 [1/dil]) and by a ≥ 4 fold rise in neutralizing antibody titers in subjects who are seropositive (≥ 10 [1/dil]) at baseline


Other Outcome Measures:
  • Number of participants reporting immediate reactions, solicited injection site and systemic reactions, unsolicited adverse events, and serious adverse events following booster vaccination. [ Time Frame: Day 0 up to 28 days post booster vaccination ] [ Designated as safety issue: No ]
    Solicited injection site: Pain, Redness and Swelling. Solicited systemic: Fever (temperature) Headache, Malaise, and Myalgia.


Estimated Enrollment: 137
Study Start Date: July 2013
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Booster Study Group
Participants who received a single dose of IMOJEV® vaccine in study JEC12 (NCT01396512) will receive a single booster dose of the same vaccine in this study.
Biological: IMOJEV®: Live Attenuated Japanese Encephalitis Chimeric Virus
0.5 mL, Subcutaneous
Other Name: IMOJEV®

Detailed Description:

All participants who previously participated in Study JEC12 (NCT 01396512) and were primed with IMOJEV® vaccine will receive a single booster dose of IMOJEV® vaccine 12 months after the primary dose. They will be assessed for immune response before and on Day 28 after the booster dose and will be monitored for safety through Day 28.

The duration of each participant's participation in the study will be approximately 6 months.

  Eligibility

Ages Eligible for Study:   2 Years to 4 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01900444

Locations
Korea, Republic of
Gangwon-do, Korea, Republic of
Gyeonggi-do, Korea, Republic of
Seoul, Korea, Republic of
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
Study Director: Medical Director Sanofi Pasteur South Korea
  More Information

Additional Information:
No publications provided

Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT01900444     History of Changes
Other Study ID Numbers: JEC22, U1111-1127-7153
Study First Received: July 11, 2013
Last Updated: January 14, 2014
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Sanofi:
Japanese encephalitis
Japanese encephalitis chimeric virus vaccine
IMOJEV®

Additional relevant MeSH terms:
Encephalitis
Encephalitis, Japanese
Central Nervous System Viral Diseases
Virus Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Central Nervous System Infections
Encephalitis, Arbovirus
Arbovirus Infections
Encephalitis, Viral
RNA Virus Infections
Flavivirus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on July 24, 2014