Phase 3
Completed N=23
Long Term Immunity and Safety Following Vaccination With the JEV IC51 (IXIARO®, JESPECT®) in Pediatric Population In Non Endemic Countries. Uncontrolled, Ph3 FU-Study
Source: ClinicalTrials.gov NCT01246479 ↗Enrolled (actual)
23
Serious AEs
8.7%
Results posted
Apr 2015
Primary outcomePrimary: Rate of Subjects With PRNT50 Titers of ≥ 1:10 at Month 12 After the First IC51 Vaccination (in Study IC51-322) — 89.5 percentage of participants
Summary
The study investigates long-term immunity and safety of IC51 (IXIARO®, JESPECT®) in a pediatric population vaccinated in the parent study IC51-322.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Subjects With PRNT50 Titers of ≥ 1:10 at Month 12 After the First IC51 Vaccination (in Study IC51-322) |
89.5 | — |
| SECONDARY GMT for JEV Neutralizing Antibodies Measured Using the PRNT at Month 12, 24 and 36 After the First IC51 Vaccination (in Study IC51-322) |
47.8; 75.4; 60.8 | — |
| SECONDARY Rate of Subjects With PRNT50 Titers of ≥ 1:10 at Months 24 and 36 After the First IC51 Vaccination (in Study IC51-322) |
91.3; 89.5 | — |
| SECONDARY Rate of Subjects With SAEs Following Immunization up to Months 12, 24 and 36 After the First IC51 Vaccination (in Study IC51-322) |
1; 2; 2 | — |
| SECONDARY Rate of Subjects With AEs and Medically Attended AEs up to Months 12, 24 and 36 After the First IC51 Vaccination (in Study IC51-322). |
7; 7; 7; 8; 8; 8 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects who have received two vaccinations in study IC51 322. (2) Subjects who were enrolled as part of the immunogenicity subgroup of study IC51-322.
- Male or female healthy subjects aged ≥ 9 months to = 0.05 mg/kg/day. Topical or inhaled steroids are allowed).
- Known infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV).
- Illicit drug use and/or a history of drug or alcohol addiction and/or current drug or alcohol addiction.
- Inability or unwillingness by the legal representative(s) and/or the subject (where applicable) to provide informed consent/assent and to abide by the requirements of the study.
- Persons who are committed to an institution (by virtue of an order issued either by the judicial or the administrative authorities).
Data sourced from ClinicalTrials.gov (NCT01246479). 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. Informational only — not medical advice.