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

NCT01001988 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: JEC05U1111-1112-2127
• Study Type: interventional
• Target: 596
• Locations: 2 countries
• Sites: 4

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

Conditions

Encephalitis; Japanese Encephalitis

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants With Japanese Encephalitis Seroprotection Following a Single Dose of JE-CV

  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).

  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

• Summary of Geometric Mean Titers of Japanese Encephalitis Virus Antibodies Following a Single Dose of a JE-CV

  Geometric mean titers of Japanese encephalitis virus antibodies were assessed using the PRNT50 test.

  Day 0 (pre-vaccination) from JEC02, Day 28 post-vaccination from JEC02, and at Years 1, 2, 3, 4, and 5 post-vaccination

Study Arms (1)

Study group

EXPERIMENTAL

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; Biological: JE-CV administered in Study JEC02

Interventions

Blood sample OTHER

Blood sample for immunogenicity assessment

Study group

JE-CV administered in Study JEC02 BIOLOGICAL

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

Study group

Eligibility Criteria

• Age: 2 Years - 3 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Planned participation in another clinical trial up to the first year of the follow-up in the present trial.

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (4)

Unknown Facility

City of Muntinlupa, 1781, Philippines

Location

Unknown Facility

Bangkok, 10330, Thailand

Location

Unknown Facility

Bangkok, 10400, Thailand

Location

Unknown Facility

Khon Kaen, 40002, Thailand

Location

Related Links

• Related Info

MeSH Terms

Conditions

Encephalitis; Encephalitis, Japanese

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neuroinflammatory Diseases; Encephalitis, Arbovirus; Encephalitis, Viral; Central Nervous System Viral Diseases; Central Nervous System Infections; Infections; Infectious Encephalitis; Arbovirus Infections; Vector Borne Diseases; Mosquito-Borne Diseases; Virus Diseases; RNA Virus Infections; Flavivirus Infections; Flaviviridae Infections

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Results Point of Contact

• Title: Medical Director
• Organization: Sanofi Pasteur

RegistryContactUS@sanofi.com

800-633-1610

Study Officials

• Medical Director

  Sanofi Pasteur Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2009
• First Posted: October 27, 2009
• Study Start: August 7, 2009
• Primary Completion: October 16, 2013
• Study Completion: October 16, 2013
• Last Updated: November 29, 2017
• Results First Posted: November 29, 2017

Record last verified: 2017-10

Locations

PH (1); TH (3)