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

• ClinicalTrials.gov Identifier: NCT01001988
• Recruitment Status: Completed
• First Posted: October 27, 2009
• Results First Posted: November 29, 2017
• Last Update Posted: November 29, 2017
• Sponsor: Sanofi Pasteur, a Sanofi Company
• Information provided by (Responsible Party): Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Description

Brief Summary:

This is a long-term follow-up of the persistence of immune response in participants who previously received a single dose of JE-CV at age 12 to 18 months in Study JEC02 (NCT00735644) . No vaccination was administered during the present long-term follow-up study.

Primary Objective:

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

Condition or disease	Intervention/treatment	Phase
Encephalitis; Japanese Encephalitis	Other: Blood sample; Biological: JE-CV administered in Study JEC02	Phase 3

Detailed Description:

Persistence of immune response will be determined in participants who previously received a single dose of JE-CV at age 12 to 18 months in Study JEC02 (NCT00735644). No vaccination will be given in this study.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 596 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Long-term Follow-up of Immunogenicity of a Single Dose of JE-CV in Toddlers in Thailand and the Philippines
• Actual Study Start Date: August 7, 2009
• Actual Primary Completion Date: October 16, 2013
• Actual Study Completion Date: October 16, 2013

Arms and Interventions

Arm	Intervention/treatment
Experimental: Study group; Participants received a single dose of JE-CV administered in Study JEC02. In Study JEC05 there were yearly visits with blood samples taken for immunogenicity assessment.	Other: Blood sample; Blood sample for immunogenicity assessment; Biological: JE-CV administered in Study JEC02; Participants received a single dose of JE-CV at 12 to 18 months of age in Study JEC02. No vaccination was administered in Study JEC05

Outcome Measures

Primary Outcome Measures :

1. Percentage of Participants With Japanese Encephalitis Seroprotection Following a Single Dose of JE-CV [ Time Frame: Day 0 (pre-vaccination) from study JEC02, Day 28 post-vaccination from study JEC02, and at Years 1, 2, 3, 4, and 5 post-vaccination ]
   Seroprotection was defined as the proportion of participants with Japanese encephalitis virus neutralizing antibody titers ≥10 1/dil as measured by a JE 50% plaque reduction neutralization test (PRNT50).
2. Summary of Geometric Mean Titers of Japanese Encephalitis Virus Antibodies Following a Single Dose of a JE-CV [ Time Frame: Day 0 (pre-vaccination) from JEC02, Day 28 post-vaccination from JEC02, and at Years 1, 2, 3, 4, and 5 post-vaccination ]
   Geometric mean titers of Japanese encephalitis virus antibodies were assessed using the PRNT50 test.

Eligibility Criteria

• Ages Eligible for Study: 2 Years to 3 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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.
• Participant who was vaccinated with JE-CV in JEC02 trial and had a pre-vaccination blood sample at baseline in JEC02 trial.
• Participant 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 up to the first year of the follow-up in the present trial.

Contacts and Locations

Locations

Philippines

Muntinlupa, Philippines, 1781

Thailand

Bangkok, Thailand, 10330

Bangkok, Thailand, 10400

Khon Kaen, Thailand, 40002

Sponsors and Collaborators

Sanofi Pasteur, a Sanofi Company

Investigators

• Study Director: Medical Director; Sanofi Pasteur Inc.

More Information

Additional Information:

Related Info 

Related Info 

• Responsible Party: Sanofi Pasteur, a Sanofi Company
• ClinicalTrials.gov Identifier: NCT01001988
• Other Study ID Numbers: JEC05; U1111-1112-2127 ( Other Identifier: WHO )
• First Posted: October 27, 2009
• Results First Posted: November 29, 2017
• Last Update Posted: November 29, 2017
• Last Verified: October 2017

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):

Encephalitis; Japanese Encephalitis; Japanese Encephalitis Chimeric Virus Vaccine; Toddlers

Additional relevant MeSH terms:

Encephalitis, Japanese; Encephalitis; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Encephalitis, Arbovirus; Arbovirus Infections; Virus Diseases; Encephalitis, Viral; Central Nervous System Viral Diseases; RNA Virus Infections; Flavivirus Infections; Flaviviridae Infections; Infectious Encephalitis; Central Nervous System Infections