Study of Japanese Encephalitis Chimeric Virus Vaccine Given With Measles-Mumps-Rubella Vaccine in Taiwanese Toddlers

NCT ID: NCT01188343

Last Updated: 2014-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 542 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2012-12-31

Brief Summary

This study is designed to compare the immunogenicity of Japanese encephalitis chimeric virus vaccine (JE-CV) and measles-mumps-rubella (MMR)vaccine when given together or when given at separate visits 6 weeks apart in toddlers aged 12 to 18 months.

Primary objective:

• To demonstrate the non-inferiority of the antibody responses in terms of seroconversion of the concomitant administration of JE-CV and MMR compared to the antibody responses after the single administration of JE-CV and MMR vaccine.

Secondary objectives:

• To describe the immune response to JE CV and MMR before and after one dose of JE CV and MMR vaccine, respectively.
• To describe the safety of a single dose of JE-CV and MMR vaccine (given separately at a 6-week interval and the safety of the concomitant administration of JE-CV and MMR vaccine in all subjects up to 6 months after last vaccination.

Detailed Description

All participants will receive Japanese encephalitis chimeric virus vaccine and measles-mumps-rubella vaccine and will be monitored for safety throughout the study.

Conditions

Japanese Encephalitis; Measles; Mumps; Rubella

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Group 1

Participants will receive the Japanese encephalitis chimeric virus vaccine (JE-CV) on Day 0 and Measles, mumps, and rubella live attenuated virus vaccine (MMR) on Day 42

Group Type: EXPERIMENTAL

Japanese encephalitis chimeric virus: Measles, mumps, and rubella live attenuated virus

Intervention Type: BIOLOGICAL

0.5 mL each; Subcutaneous (SC)

Group 2

Participants will receive Measles, mumps, and rubella live attenuated virus vaccine (MMR) on Day 0, and the Japanese encephalitis chimeric virus vaccine (JE-CV) on Day 42.

Group Type: EXPERIMENTAL

Japanese encephalitis chimeric virus: Measles, mumps, and rubella live attenuated virus

Intervention Type: BIOLOGICAL

0.5 mL each, Subcutaneous (SC)

Group 3

Participants will receive the Measles, mumps, and rubella live attenuated virus vaccine (MMR) and the Japanese encephalitis chimeric virus vaccine (JE-CV) on Day 0

Group Type: EXPERIMENTAL

Japanese encephalitis chimeric virus: Measles, mumps, and rubella live attenuated virus

Intervention Type: BIOLOGICAL

0.5 mL each, subcutaneous (SC)

Interventions

Japanese encephalitis chimeric virus: Measles, mumps, and rubella live attenuated virus

0.5 mL each; Subcutaneous (SC)

Intervention Type: BIOLOGICAL

Japanese encephalitis chimeric virus: Measles, mumps, and rubella live attenuated virus

0.5 mL each, Subcutaneous (SC)

Intervention Type: BIOLOGICAL

Japanese encephalitis chimeric virus: Measles, mumps, and rubella live attenuated virus

0.5 mL each, subcutaneous (SC)

Intervention Type: BIOLOGICAL

Other Intervention Names

JE-CV; MMR II®; JE-CV; MMR II®; JE-CV; MMR II®

Eligibility Criteria

Inclusion Criteria

• Aged 12 to 18 months on the day of inclusion .
• Born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg.
• Subject in good health based on medical history and physical examination.
• Provision of informed consent form signed by at least one parent or other legally acceptable representative, and by an independent witness if the parents or legally acceptable representative cannot read.
• Subject and parent/legally acceptable representative or delegate 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 first trial vaccination.
• Planned participation in another clinical trial during the present trial period.
• 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 up to the 6 weeks following the last trial vaccination except for pandemic influenza vaccine. In the event of a local or national immunization program with a pandemic influenza vaccine, participants who receive a pandemic influenza vaccine at any time during the trial will not be withdrawn from the trial.
• Previous vaccination against measles, measles-mumps-rubella (MMR), or flavivirus disease, including Japanese encephalitis (JE).
• Receipt of blood in the past 6 months that might interfere with the assessment of the immune response
• Receipt of intravenous injection of plasma, platelet product, or high dose of intravenous immunoglobulin in the past 11 months
• Receipt of intramuscular treatment of immunoglobulin or Hepatitis B immunoglobulin in the past 3 months
• Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy.
• Known history of human immunodeficiency virus, hepatitis B surface antigen, or hepatitis C seropositivity.
• History of measles, mumps, rubella, or flavivirus infection confirmed either clinically, serologically, or microbiologically.
• Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to a vaccine containing any of the same substances .
• Known systemic hypersensitivity to gelatin, eggs, or anaphylactic/anaphylactoid reaction to neomycin.
• Known history of thrombocytopenia.
• Administration of any anti-viral within 2 months preceding first vaccination and up to the 6 weeks following the last trial vaccination.
• History of central nervous system disorder or disease, including seizures and febrile seizures.
• Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator.

• Minimum Eligible Age: 12 Months
• Maximum Eligible Age: 18 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sanofi Pasteur, a Sanofi Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Sanofi Pasteur Inc.

Locations

Taichung, , Taiwan

Taipei, , Taiwan

Taoyuan District, , Taiwan

Countries

Taiwan

Related Links

http://www.sanofipasteur.com

Related Info

Other Identifiers

UTN: U1111-1112-2143

Identifier Type: OTHER

Identifier Source: secondary_id

JEC04

Identifier Type: -

Identifier Source: org_study_id