Phase 3
N=596
Long-term Follow-up of Immunogenicity of a Single Dose of Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) in Toddlers
Encephalitis · Japanese Encephalitis
Bottom Line
View on ClinicalTrials.gov: NCT01001988 ↗Enrolled (actual)
596
Serious AEs
0.0%
Results posted
Nov 2017
Primary outcome: Primary: Percentage of Participants With Japanese Encephalitis Seroprotection Following a Single Dose of JE-CV — 2.6; 100.0; 88.2; 90.0 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Blood sample (Other); JE-CV administered in Study JEC02 (Biological)
- Age
- Pediatric · 2+ yrs
- Sex
- All
- Sponsor
- Sanofi Pasteur, a Sanofi Company
- Primary completion
- Oct 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Japanese Encephalitis Seroprotection Following a Single Dose of JE-CV |
2.6; 100.0; 88.2; 90.0; 93.1; 87.6 | — |
| PRIMARY Summary of Geometric Mean Titers of Japanese Encephalitis Virus Antibodies Following a Single Dose of a JE-CV |
5.13; 252; 76.8; 81.4; 132; 85.8 | — |
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
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01001988). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.