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Long-term Follow-up of Immunogenicity of a Single Dose of Japanese Encephalitis Chimeric Virus Vaccine in Toddlers

PHRR121127-000022

Protocol No. JEC05

Unspecified

Long-term Follow-up of Immunogenicity of a Single Dose of Japanese Encephalitis Chimeric Virus Vaccine in Toddlers in Thailand and the Philippines

This is a follow-up of Study JEC02 (NCT 00735644) designed to characterize the persistence of neutralizing antibodies in the five years after vaccination with Japanese encephalitis chimeric vaccine (JE-CV).

Start Date Duration in Months Target Completion Date Actual Completion Date
2009-08-01 59 2014-07-01 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

Encephalitis, Japanese Encephalitis

•To describe the yearly persistence of humoral immune response to Japanese encephalitis after a single dose of JE-CV

Unspecified

Completed

  • Philippines
  • Thailand

Clinical Trial

Unspecified

Unspecified

None

Inclusion Criteria : •Provision of Informed Consent Form signed by at least one parent or other legally acceptable representative, and by at least one independent witness if required by local regulations. •Subject who was vaccinated with Japanese encephalitis chimeric vaccine (JE-CV) in JEC02 trial and had a pre-vaccination blood sample at baseline in JEC02 trial. •Subject and parent/legally acceptable representative able to attend all scheduled visits and comply with all trial procedures. Exclusion Criteria : •Receipt of any JE vaccine other than JE-CV during JEC02 trial and during the period up to inclusion in JEC05 trial. •Planned participation in another clinical trial during the present trial period.

Observational

Unspecified

Unspecified

Non-randomized

NA

Unspecified

Not Applicable

Observation

Phase III

230

Unspecified

NA

01 Aug 2009

Utilization Utilization Info
No records found.

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