Trial record 1 of 1 for:
JEC22
Study of a Booster Dose of IMOJEV® One Year After Primary Immunization in Healthy Children in South Korea
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01900444 |
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Recruitment Status :
Completed
First Posted : July 16, 2013
Results First Posted : December 13, 2017
Last Update Posted : December 13, 2017
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Sponsor:
Sanofi Pasteur, a Sanofi Company
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
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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 |
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 |
| Allocation: | N/A |
| 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 |
| Actual Primary Completion Date : | March 11, 2014 |
| Actual Study Completion Date : | March 11, 2014 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Encephalitis
| Arm | Intervention/treatment |
|---|---|
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Experimental: IMOJEV Group
Participants who received a single dose of IMOJEV in study JEC12 (NCT01396512) will receive a booster dose in this study.
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Biological: IMOJEV
0.5 mL, Subcutaneous
Other Name: Japanese Encephalitis Chimeric Virus Vaccine |
Primary Outcome Measures :
- 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).
- 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.
- 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.
- 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.
- 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).
- 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.
- 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.
- 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.
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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 |
| 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 ):
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Japanese encephalitis Japanese encephalitis chimeric virus vaccine IMOJEV® |
Additional relevant MeSH terms:
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Encephalitis, Japanese Encephalitis 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 |