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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT01188343
First received: August 24, 2010
Last updated: March 28, 2013
Last verified: March 2013
  Purpose

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.

Condition Intervention Phase
Japanese Encephalitis
Measles
Mumps
Rubella
Biological: Japanese encephalitis chimeric virus: Measles, mumps, and rubella live attenuated virus
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Immunogenicity and Safety of Japanese Encephalitis Chimeric Virus Vaccine (JE CV) Concomitantly Administered With Measles, Mumps, and Rubella (MMR) Vaccine in Toddlers in Taiwan.

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Immunogenicity of Japanese encephalitis chimeric virus vaccine and of measles-mumps-rubella vaccine. [ Time Frame: 42 Days post-vaccination ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety of a single dose of JE CV and MMR vaccine (given separately) and the safety of the concomitant administration of JE CV and MMR vaccine in all subjects in terms of solicited injection sites and systemic reactions and unsolicited adverse events. [ Time Frame: Day 0 to 6 months post-vaccination. ] [ Designated as safety issue: Yes ]

Enrollment: 542
Study Start Date: August 2010
Study Completion Date: December 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
Biological: Japanese encephalitis chimeric virus: Measles, mumps, and rubella live attenuated virus
0.5 mL each; Subcutaneous (SC)
Other Names:
  • JE-CV
  • MMR II®
Experimental: 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.
Biological: Japanese encephalitis chimeric virus: Measles, mumps, and rubella live attenuated virus
0.5 mL each, Subcutaneous (SC)
Other Names:
  • JE-CV
  • MMR II®
Experimental: 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
Biological: Japanese encephalitis chimeric virus: Measles, mumps, and rubella live attenuated virus
0.5 mL each, subcutaneous (SC)
Other Names:
  • JE-CV
  • MMR II®

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.

  Eligibility

Ages Eligible for Study:   12 Months to 18 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01188343

Locations
Taiwan
Taichung, Taiwan
Taipei, Taiwan
Taoyuan, Taiwan
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
Study Director: Medical Director Sanofi Pasteur Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT01188343     History of Changes
Other Study ID Numbers: JEC04, UTN: U1111-1112-2143
Study First Received: August 24, 2010
Last Updated: March 28, 2013
Health Authority: Taiwan: Department of Health

Keywords provided by Sanofi:
Japanese Encephalitis
Japanese encephalitis chimeric virus vaccine
Measles
Mumps
Rubella

Additional relevant MeSH terms:
Measles
Encephalitis
Encephalitis, Japanese
Mumps
Parotitis
Rubella
Central Nervous System Viral Diseases
Virus Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Central Nervous System Infections
Encephalitis, Arbovirus
Arbovirus Infections
Encephalitis, Viral
RNA Virus Infections
Flavivirus Infections
Flaviviridae Infections
Morbillivirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
Rubulavirus Infections
Parotid Diseases
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Sialadenitis
Rubivirus Infections
Togaviridae Infections

ClinicalTrials.gov processed this record on July 22, 2014