Loading clinical trials...

COMPLETEDPHASE3

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

Immunogenicity and Safety of a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) Given to Healthy Subjects in Vietnam

NCT02492165•Sanofi Pasteur, a Sanofi Company

View on ClinicalTrials.gov

Summary

The purpose of this study is to describe the immunogenicity and safety of IMOJEV® in adult and pediatric populations in Vietnam and serve a bridging study to compare immunogenicity, reactogenicity, and safety data obtained with IMOJEV® in the Vietnamese population with data from other Asian pediatric populations. Primary objective: \- To describe the safety profile of a single dose of IMOJEV®. Secondary objectives: * To evaluate the immune response to JE 28 days after the administration of a single dose of IMOJEV® in healthy Vietnamese subjects aged from 9 months to 60 years.

Detailed Description

Study participants will be enrolled by age group and will each receive one injection of IMOJEV® on Day 0 given as primary vaccination. They will be assessed for immunogenicity and safety, post-vaccination.

Eligibility

Age

0 - 60 years

Sex

ALL

Healthy Volunteers

Yes

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.
+7 more criteria

Locations (1)

Preventive Medicine Centre of Hoa Binh Province

Hòa Bình, Vietnam

Key Dates

Start Date

June 1, 2015

Primary Completion Date

March 1, 2016

Completion Date

June 1, 2016

Last Updated

March 28, 2022

Enrollment

250

ACTUAL participants

Conditions

Japanese Encephalitis

Interventions

Live attenuated Japanese encephalitis chimeric virus vaccine (IMOJEV®)

BIOLOGICAL

Live attenuated Japanese encephalitis chimeric virus vaccine (IMOJEV®)

BIOLOGICAL

Live attenuated Japanese encephalitis chimeric virus vaccine (IMOJEV®)

BIOLOGICAL

Live attenuated Japanese encephalitis chimeric virus vaccine (IMOJEV®)

BIOLOGICAL

Safety Observation of the Japanese Encephalitis Vaccine Given With a Primary Immunization

NCT06372665

Japanese Encephalitis

View study

COMPLETEDPHASE3

Comparison of Three Batches of the Japanese Encephalitis Vaccine IC51

NCT00594958

Japanese Encephalitis

View study

UNKNOWNPHASE4

Seroprevalence of Neutralizing Antibodies Against Japanese Encephalitis Virus Among 6 Years Old Children With 5 Different Immunization Strategies in Zhejiang Province

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 28, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Safety Observation of the Japanese Encephalitis Vaccine Given With a Primary Immunization

Comparison of Three Batches of the Japanese Encephalitis Vaccine IC51

Seroprevalence of Neutralizing Antibodies Against Japanese Encephalitis Virus Among 6 Years Old Children With 5 Different Immunization Strategies in Zhejiang Province

Safety of Vero Cell - Derived Inactivated Japanese Encephalitis Vaccine (JECEVAX) in Children From 9-24 Months of Age

Post-licensure Safety Study of IMOJEV® in Thailand

Study of ChimeriVax™-Japanese Encephalitis Vaccine in Toddlers in Thailand and the Philippines