- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01188343
Study of Japanese Encephalitis Chimeric Virus Vaccine Given With Measles-Mumps-Rubella Vaccine in Taiwanese Toddlers
July 25, 2014 updated by: Sanofi Pasteur, a Sanofi Company
Immunogenicity and Safety of Japanese Encephalitis Chimeric Virus Vaccine (JE CV) Concomitantly Administered With Measles, Mumps, and Rubella (MMR) Vaccine in Toddlers in Taiwan.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
542
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Taichung, Taiwan
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Taipei, Taiwan
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Taoyuan, Taiwan
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 months to 2 months (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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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
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0.5 mL each; Subcutaneous (SC)
Other Names:
0.5 mL each, Subcutaneous (SC)
Other Names:
0.5 mL each, subcutaneous (SC)
Other Names:
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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.
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0.5 mL each; Subcutaneous (SC)
Other Names:
0.5 mL each, Subcutaneous (SC)
Other Names:
0.5 mL each, subcutaneous (SC)
Other Names:
|
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
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0.5 mL each; Subcutaneous (SC)
Other Names:
0.5 mL each, Subcutaneous (SC)
Other Names:
0.5 mL each, subcutaneous (SC)
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With Seroconversion to Vaccine Antigens Following Concomitant Administration of Japanese Encephalitis Chimeric Virus Vaccine (JECV) and MMR or Single Administration of JE-CV and MMR Vaccine at 42 Days Following First Vaccination
Time Frame: Day 0 (pre-vaccination) and Day 42 post-vaccination
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JE-CV antigens were measured using a 50% plaque reduction neutralization test (PRNT50); MMR antigens were measured using enzyme linked immunosorbent assay (ELISA).
Seroconversion was defined as: for JE-CV - participants with a pre-vaccination titer <1/10 and post-vaccination titer ≥1/10, or a pre-vaccination titer ≥1/10 and 4-fold increase from pre- to post; for Measles - post-vaccination titer ≥120 mIU/ml, when pre-vaccination titer is <120 mIU/ml; for Mumps - post-vaccination titer ≥1/10 U/ml when pre-vaccination titer is <10 U/ml; and for Rubella, post-vaccination titer ≥1/10 U/ml when pre-vaccination titer is <10 U/ml.
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Day 0 (pre-vaccination) and Day 42 post-vaccination
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With Seroconversion to JE-CV and MMR Antigens Before and 42 Days Following Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine
Time Frame: Pre-vaccination and Day 42 post-vaccination
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JE-CV antigens were measured using a 50% plaque reduction neutralization test (PRNT50); MMR antigens were measured using enzyme linked immunosorbent assay (ELISA).
Seroconversion was defined as: for JE-CV - participants with a pre-vaccination titer <1/10 and post-vaccination titer ≥1/10, or a pre-vaccination titer ≥1/10 and 4-fold increase from pre- to post; for Measles - post-vaccination titer ≥120 mIU/ml, when pre-vaccination titer is <120 mIU/ml; for Mumps - post-vaccination titer ≥1/10 U/ml when pre-vaccination titer is <10 U/ml; and for Rubella, post-vaccination titer ≥1/10 U/ml when pre-vaccination titer is <10 U/m
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Pre-vaccination and Day 42 post-vaccination
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Number of Participants With Seroprotection to JE-CV and MMR Antigens Before, at Month 6 After Last Vaccination and Month 12 After First Following Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine
Time Frame: Pre-vaccination and up to Month 12 post-vaccination
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JE-CV antigens were measured using a 50% plaque reduction neutralization test (PRNT50); MMR antigens were measured using enzyme linked immunosorbent assay (ELISA).
Seroprotection was defined as: for JE-CV - participants with a pre-vaccination titer <1/10 (1/dil) and post-vaccination titer ≥1/10, (1/dil) or a pre-vaccination titer ≥1/10 and 4-fold increase from pre- to post; for Measles - post-vaccination titer ≥120 mIU/ml, when pre-vaccination titer is <120 mIU/ml; for Mumps - post-vaccination titer ≥1/10 units/ml when pre-vaccination titer is <10 units/ml; and for Rubella, post-vaccination titer ≥1/10 IU/ml when pre-vaccination titer is <10 IU/m
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Pre-vaccination and up to Month 12 post-vaccination
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Geometric Mean Titers of Antibodies to Vaccine Antigens Before and After Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine
Time Frame: Pre-vaccination and Day 42 post-vaccination
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JE-CV antigens were measured using a 50% plaque reduction neutralization test (PRNT50); MMR antigens were measured using enzyme linked immunosorbent assay (ELISA).
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Pre-vaccination and Day 42 post-vaccination
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Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of JE-CV Vaccine
Time Frame: Day 0 up to Day14 post-vaccination
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Solicited injection site: Pain, Erythema, and Swelling; Solicited systemic reactions: Fever (Temperature), Vomiting, Crying Abnormal, Drowsiness, Appetite Lost, and Irritability.
Grade 3 injection site: Pain - Cries when injected limb is moved or movement of limb is reduced; Erythema and Swelling - ≥5 cm.
Grade 3 systemic reactions: Fever - >39.5°C; Vomiting - ≥6 episodes per 24 hours or requiring parenteral hydration; Crying Abnormal - >3 hours; Drowsiness - Sleeping most of the time or difficult to wake; Appetite Lost - Refused ≥3 feeds/meals or refused most feeds/meals; Irritability - Inconsolable.
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Day 0 up to Day14 post-vaccination
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Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of MMR Vaccine
Time Frame: Day 0 up to Day 14 post-vaccination
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Solicited injection site: Pain, Erythema, and Swelling; Solicited systemic reactions: Fever (Temperature), Vomiting, Crying Abnormal, Drowsiness, Appetite Lost, and Irritability.
Grade 3 injection site: Pain - Cries when injected limb is moved or movement of limb is reduced; Erythema and Swelling - ≥5 cm.
Grade 3 systemic reactions: Fever - >39.5°C; Vomiting - ≥6 episodes per 24 hours or requiring parenteral hydration; Crying Abnormal - >3 hours; Drowsiness - Sleeping most of the time or difficult to wake; Appetite Lost - Refused ≥3 feeds/meals or refused most feeds/meals; Irritability - Inconsolable.
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Day 0 up to Day 14 post-vaccination
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Serological Status of Flavivirus at Before (Baseline) Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine
Time Frame: Day 0 (pre-vaccination)
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Neutralizing antibodies levels against dengue were only evaluated on subjects ELISA positive for Immunoglobulin G (IgG) or Immunoglobulin M (IgM).
Flavivirus positive was defined as antibodies against JE-CV virus ≥10 (l/dil) or antibodies against at least one dengue virus serotype ≥10 (l/dil); Flavivirus negative was defined as antibodies against JE CV virus < 10 (l/dil) and antibodies against the 4 dengue virus serotypes < 10 (l/dil).
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Day 0 (pre-vaccination)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2010
Primary Completion (Actual)
July 1, 2012
Study Completion (Actual)
December 1, 2012
Study Registration Dates
First Submitted
August 24, 2010
First Submitted That Met QC Criteria
August 24, 2010
First Posted (Estimate)
August 25, 2010
Study Record Updates
Last Update Posted (Estimate)
August 15, 2014
Last Update Submitted That Met QC Criteria
July 25, 2014
Last Verified
July 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Stomatognathic Diseases
- Mouth Diseases
- Encephalitis, Arbovirus
- Encephalitis, Viral
- Central Nervous System Viral Diseases
- Central Nervous System Infections
- Infectious Encephalitis
- Arbovirus Infections
- Vector Borne Diseases
- Flavivirus Infections
- Flaviviridae Infections
- Morbillivirus Infections
- Paramyxoviridae Infections
- Mononegavirales Infections
- Salivary Gland Diseases
- Togaviridae Infections
- Rubivirus Infections
- Rubulavirus Infections
- Parotitis
- Parotid Diseases
- Encephalitis, Japanese
- Encephalitis
- Measles
- Rubella
- Mumps
Other Study ID Numbers
- JEC04
- UTN: U1111-1112-2143 (Other Identifier: WHO)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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