Study of a Single Primary Dose Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) in Healthy Subjects

• Register: ClinicalTrials.gov
• Last refreshed on: 4 April 2022
• Main ID: NCT02492165
• Date of registration: 05/07/2015
• Prospective Registration: No
• Primary sponsor: Sanofi Pasteur, a Sanofi Company
• Public title: Study of a Single Primary Dose Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) in Healthy Subjects
• Scientific title: Immunogenicity and Safety of a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) Given to Healthy Subjects in Vietnam
• Date of first enrolment: June 2015
• Target sample size: 250
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02492165
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Vietnam

Contacts

• Name: Medical Director
• Affiliation: Sanofi Pasteur SA

Key inclusion & exclusion criteria

Inclusion Criteria:

- Aged 9 months through 60 years on the day of inclusion.

- For adults: Informed consent form has been signed and dated by the subject. For
minors: Informed consent form has been signed and dated by the parent or legally
acceptable representative. In addition, in accordance with the Institution Ethics
Committee / Institution Review Board requirements and as appropriate for the age of
the subject, the subject may be required to sign and date the informed consent form if
aged 12 to 17 years or assent form if aged 8 to 11 years.

- Subject and parent(s)/legally acceptable representative(s) are able to attend all
scheduled visits and comply with all study procedures.

Exclusion Criteria:

- Subject is pregnant, or lactating, or of childbearing potential (to be considered of
non-childbearing potential, a female must be pre-menarche, or post-menopausal for at
least 1 year, or surgically sterile, or using an effective method of contraception or
abstinence from at least 4 weeks prior to vaccination until at least 4 weeks after
vaccination).

- Participation at the time of study enrollment (or in the 4 weeks preceding the study
vaccination) or planned participation during the present study period in another
clinical study investigating a vaccine, drug, medical device, or a medical procedure.

- Receipt of any vaccine in the 4 weeks preceding the study vaccination or planned
receipt of any vaccine in the 4 weeks following the study vaccination, except for
inactivated influenza vaccination, which may be received at least 2 weeks before the
study vaccine

- Previous vaccination against flavivirus disease, including Japanese Encephalitis (JE),
dengue, and yellow fever.

- Receipt of immune globulins, blood, or blood-derived products in the past 3 months
that might interfere with the assessment of the immune response.

- 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 (for more than 2
consecutive weeks within the 4 weeks preceding vaccination).

- History of flavivirus infection (confirmed either clinically, serologically, or
virologically).

- History of central nervous system disorder or disease, including seizures.

- Known systemic hypersensitivity to any of the vaccine components, or history of a
life-threatening reaction to the vaccine used in the study or to a vaccine containing
any of the same substances.

- Known thrombocytopenia, contraindicating vaccination.

- Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion,
contraindicating vaccination.

- Deprived of freedom by an administrative or court order, or in an emergency setting,
or hospitalized involuntarily.

- Current alcohol abuse or drug addiction.

- Chronic illness that, in the opinion of the investigator, is at a stage where it might
interfere with study conduct or completion.

- Febrile illness (temperature = 38.0°C) or moderate or severe acute illness/infection
on 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.

- Receipt of any chronic anti-viral in the 2 months preceding the study vaccination or
planned receipt of any anti-viral in the 4 weeks following the study vaccination.
Short-term antiviral drugs for flu or herpes can be administered provided there is a
wash-out period of 1 week before the administration of the vaccine.

- Identified as an Investigator or employee of the Investigator or study center with
direct involvement in the proposed study, or identified as an immediate family member
(i.e., parent, spouse, natural or adopted child) of the Investigator or employee with
direct involvement in the proposed study.



Age minimum: 9 Months
Age maximum: 60 Years
Gender: All

Health Condition(s) or Problem(s) studied

Japanese Encephalitis

Intervention(s)

Biological: Live attenuated Japanese encephalitis chimeric virus vaccine (IMOJEV®)

Primary Outcome(s)

Percentage of Participants With Japanese Encephalitis Seroconversion Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) [Time Frame: Day 0 (pre-vaccination) and Day 28 post-vaccination]

Summary of Geometric Mean Titers of Japanese Encephalitis Antibodies Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) [Time Frame: Day 0 (pre-vaccination) and Day 28 post-vaccination]

Percentage of Participants With Japanese Encephalitis Seroprotection Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) [Time Frame: Day 0 (pre-vaccination) and Day 28 post-vaccination]

Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) [Time Frame: Day 0 up to Day 14 post-vaccination]

Secondary ID(s)

U1111-1143-8142

JEC13

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Institute of Hygiene and Epidemiology, Vietnam

Results

• Results available: Yes
• Date Posted: 29/11/2016
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02492165