Clinical trial NCT01396512: Study of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV™) Compared to CD.JEVAX™ in Toddlers
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Japanese Encephalitis
Japanese Encephalitis Virus Disease
Keywords: Japanese Encephalitis
Japanese Encephalitis Virus Disease
IMOJEV™
CD.JEVAX™
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2011-07-18
Enrollment: 274
Sex: ALL
Minimum age (years): 12
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: All participants will receive a single dose of their assigned vaccination at Visit 1 (Day 0) and undergo immunogenicity assessment at Day 28 post-vaccination. Safety will be assessed from day of vaccination and up to 6 months post-vaccination.

Eligibility criteria: Inclusion Criteria:

* Aged 12 to 24 months on the day of inclusion
* 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.

Exclusion Criteria:

* 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.
* Planned receipt of any vaccine from the inclusion up to the 4 weeks following the trial vaccination.
* 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.
* Thrombocytopenia or bleeding disorder contraindicated for vaccination with same administration route, or receipt of anticoagulants in the 3 weeks preceding inclusion.

Primary outcomes:
measure: Percentage of Participants With Seroconversion to Japanese Encephalitis Chimeric Virus Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine
timeFrame: Day 28 post-vaccination
Secondary outcomes:
measure: Geometric Mean Titers Against the Japanese Encephalitis Chimeric Virus Before And Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine
timeFrame: Day 0 (pre-vaccination) and Day 28 post-vaccination
measure: Number of Participants With Seroprotection Against Japanese Encephalitis Chimeric Virus Before And Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine
timeFrame: Day 0 (pre-vaccination) and Day 28 post-vaccination
measure: Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine
timeFrame: Day 0 up to Day 14 post-vaccination
Other outcomes:
Locations:
city: Goyang
country: Korea, Republic of
city: Incheon
country: Korea, Republic of
city: Seongnam
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Suwon
country: Korea, Republic of
city: Wonju
country: Korea, Republic of
Study officials:
affiliation: Sanofi Pasteur SA
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: 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.