Study of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV™) Compared to CD.JEVAX™ in Toddlers
Immunogenicity and Safety of a Single Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV™) in Comparison With a Single Dose of SA14-14-2 Vaccine (CD.JEVAX™, Chengdu Institute of Biological Products, China) Administered in Healthy Toddlers in South-Korea
2 other identifiers
interventional
274
1 country
6
Brief Summary
The purpose of this study is to compare Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV™) with Japanese encephalitis live attenuated vaccine (SA14 14 2 vaccine \[CD.JEVAX™\]) after a single dose vaccination to support product registration. Primary Objective:
- To demonstrate the non-inferiority of the antibody response 28 days after administration of one dose of IMOJEV™ compared to the antibody response 28 days after administration of one dose of the CD.JEVAX™ control vaccine. Secondary Objectives:
- To describe the immune response to Japanese encephalitis (JE) in both vaccine groups using 50% plaque reduction neutralization assay (PRNT50) assays before and after a single dose of IMOJEV™ vaccine or a single dose of CD.JEVAX™ vaccine.
- To describe the safety of vaccination in all subjects up to 28 days and all serious adverse events up to 6-month after vaccination.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jul 2011
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 14, 2011
CompletedFirst Posted
Study publicly available on registry
July 18, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedResults Posted
Study results publicly available
April 25, 2014
CompletedApril 25, 2014
March 1, 2014
1.7 years
July 14, 2011
March 24, 2014
March 24, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Seroconversion to Japanese Encephalitis Chimeric Virus Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine
Immunogenicity assessed using a Japanese encephalitis chimeric virus (JE-CV) 50% Plaque Reduction Neutralization Test (PRNT50). Seroconversion was defined as the percentage of participants who developed neutralizing antibody titers above 10 (1/dil) when seronegative at baseline (\<1/10) or who presented a ≥4-fold rise in their neutralizing antibody titers when seropositive (≥1/10) at baseline.
Day 28 post-vaccination
Secondary Outcomes (3)
Geometric Mean Titers Against the Japanese Encephalitis Chimeric Virus Before And Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine
Day 0 (pre-vaccination) and Day 28 post-vaccination
Number of Participants With Seroprotection Against Japanese Encephalitis Chimeric Virus Before And Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine
Day 0 (pre-vaccination) and Day 28 post-vaccination
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine
Day 0 up to Day 14 post-vaccination
Study Arms (2)
IMOJEV™ Vaccine Group
EXPERIMENTALParticipants will receive a single dose of the Live attenuated Japanese encephalitis chimeric virus vaccine (IMOJEV™) on Day 0.
CD.JEVAX ™ Vaccine Group
ACTIVE COMPARATORParticipants will receive a single dose of the Japanese encephalitis live attenuated vaccine (SA14 14 2 vaccine), CD.JEVAX™ on Day 0
Interventions
0.5 mL, Subcutaneous
0.5 mL, Subcutaneous
Eligibility Criteria
You may qualify if:
- In good general health, without significant medical history.
- Provision of informed consent form signed by at least one parent or other legally acceptable representative.
- Subject and parent/guardian able to attend all scheduled visits and comply with all trial procedures.
You may not qualify if:
- Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the trial vaccination.
- Planned participation in another clinical trial during the present trial period.
- 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 IMOJEV™ components or history of a life-threatening reaction to a vaccine containing any of the same substances and vaccination,known systemic hypersensitivity to CD.JEVAX® main components and the other components (including Gelatin, kanamycin, and gentamicin).
- Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator.
- Receipt of 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 Japanese encephalitis (JE).
- Administration of any anti-viral within 2 months preceding Visit 01 and up to the 4 weeks following the trial vaccination.
- Receipt of any vaccine in the 4 weeks preceding the first trial vaccination, except for pandemic influenza vaccination, which may be received at least two weeks before the study vaccines.
- 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 two consecutive weeks within the 4 weeks preceding 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Unknown Facility
Goyang, South Korea
Unknown Facility
Incheon, South Korea
Unknown Facility
Seongnam, South Korea
Unknown Facility
Seoul, South Korea
Unknown Facility
Suwon, South Korea
Unknown Facility
Wŏnju, South Korea
Related Publications (1)
Kim DS, Houillon G, Jang GC, Cha SH, Choi SH, Lee J, Kim HM, Kim JH, Kang JH, Kim JH, Kim KH, Kim HS, Bang J, Naimi Z, Bosch-Castells V, Boaz M, Bouckenooghe A. A randomized study of the immunogenicity and safety of Japanese encephalitis chimeric virus vaccine (JE-CV) in comparison with SA14-14-2 vaccine in children in the Republic of Korea. Hum Vaccin Immunother. 2014;10(9):2656-63. doi: 10.4161/hv.29743. Epub 2014 Nov 6.
PMID: 25483480DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Director
- Organization
- Sanofi Pasteur Inc.
Study Officials
- STUDY DIRECTOR
Medical Director
Sanofi Pasteur SA
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 14, 2011
First Posted
July 18, 2011
Study Start
July 1, 2011
Primary Completion
March 1, 2013
Study Completion
June 1, 2013
Last Updated
April 25, 2014
Results First Posted
April 25, 2014
Record last verified: 2014-03