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Study of Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) in Children Previously Immunized With JE-CV

PHRR121127-000021

Protocol No. JEC15

Unspecified

Assessment of the Memory Immune Response, Safety of Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) in Children Previously Immunized With a Single Dose of JE-CV and Long-Term Follow-Up

The aim of the study is to investigate the memory immune response and the yearly persistence of the immunity against Japanese Encephalitis (JE) after vaccination with a new Japanese Encephalitis Chimeric Virus (JE-CV) in participants previously vaccinated with JE-CV.

Start Date Duration in Months Target Completion Date Actual Completion Date
2010-08-01 69 2016-05-01 0000-00-00

Ongoing

Institution Classification Region LTO #
Sanofi Pasteur Private Business NCR
Institution Amount Region
Sanofi Pasteur N/A NCR
Name E-Mail Phone Number Postal Address
Erah Jean Baria erahjean.baria@sanofi pasteur.com +632 4799106 4F Feliza Bldg, 108 V.A Rufino St., Legaspi Village Makati City
Name E-Mail Phone Number Postal Address
Thelma Laot thelma.laot@sanofipasteur.com +632 4799106 4F Feliza Bldg, 108 V.A Rufino St., Legaspi Village Makati City
Name Expertise Affiliation
Maria Rosario Z. Capeding, MD Consultant, Pediatric and Infectious Diseases Research Institute for Tropical Medicine
Project Location Institutional Ethics Review Board
Research Institute for Tropical Medicine Research Institute for Tropical Medicine Institutional Review Board

Japanese Encephalitis Varicella

•To describe JE immune status before, and after a JE-CV booster dose in subjects previously vaccinated with JE-CV •To describe the immune status before, and immune response following JE-CV vaccination in JE-naïve control subjects.

Unspecified

Completed

  • Philippines

Clinical Trial

Unspecified

Unspecified

None

Inclusion Criteria •Aged 36 to 42 months on the day of inclusion •Provision of Informed Consent Form signed by at least one parent or other legally acceptable representative. •Subject and parent/legally acceptable representative or guardian able to attend all scheduled visits and to comply with all trial procedures •In good general health, based on medical history and physical examination For Japanese Encephalitis Chimeric Virus (JE-CV) vaccine primed group only •Subject who was vaccinated with JE-CV in JEC02 trial (NCT00735644) Exclusion Criteria •History of central nervous system disorder or disease, including seizures and febrile seizures •Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances •Chronic illness or any underlying illness (such as cardiovascular, kidney, liver or hematological disease or development abnormalities) that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion For Japanese Encephalitis Chimeric Virus (JE-CV) primed participants only •Receipt of any Japanese Encephalitis (JE) vaccine other than JE-CV during JEC02 trial (NCT00735644) and since the end of JEC02 trial For JE-CV naive participants only •Previous vaccination against flavivirus disease including JE •History of flavivirus infection either based on clinical suspicion or laboratory proven •Previous vaccination against varicella •Previous vaccination with JE-CV in JEC02 study •History of varicella, confirmed either clinically, serologically, or microbiologically •Known systemic hypersensitivity or anaphylactic/anaphylactoid reaction to neomycin. •Known history of thrombocytopenia or idiopathic thrombocytopenic purpura.

Interventional

Biological:Japanese encephalitis chimeric virus; Biological: Varicella vaccine

Study participants who are previously immunized with Japanese Encephalitis Chimeric Virus (JE-CV) vaccine will receive a single dose of the new JE-CV and will be followed up for 5 years for immunogenicity. The control (JE-CV naive) participants will receive either one dose of JE-CV or one dose of varicella vaccine. All participants will be monitored for safety for 6 month post vaccination.

Randomized

Open Label

Unspecified

Parallel

Prevention

Phase III

505

505

NA

01 Aug 2010

Utilization Utilization Info
No records found.

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