Long Term Immunity and Safety Following Vaccination With the JEV IC51 (IXIARO®, JESPECT®) in Pediatric Population In Non Endemic Countries. Uncontrolled, Ph3 FU-Study
This study is ongoing, but not recruiting participants.
Sponsor:
Intercell AG
Information provided by (Responsible Party):
Intercell AG
ClinicalTrials.gov Identifier:
NCT01246479
First received: October 6, 2010
Last updated: February 1, 2013
Last verified: February 2013
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Purpose
The study investigates long-term immunity and safety of IC51 (IXIARO®, JESPECT®) in a pediatric population vaccinated in the parent study IC51-322.
| Condition | Intervention | Phase |
|---|---|---|
|
Japanese Encephalitis |
Procedure: Blood draw Biological: IC51 has given in the parent study IC51-322 |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label |
| Official Title: | Long Term Immunity and Safety Following Vaccination With the Japanese Encephalitis Vaccine IC51(IXIARO®, JESPECT®) In a Pediatric Population in Non Endemic Countries. Uncontrolled, Phase 3 Follow-up Study |
Resource links provided by NLM:
Further study details as provided by Intercell AG:
Primary Outcome Measures:
- Rate of subjects with PRNT50 titers of ≥ 1:10 at Month 12 after the first IC51 vaccination (in study IC51-322) [ Time Frame: Month 12 ] [ Designated as safety issue: No ]Rate of subjects with PRNT50 titers of ≥ 1:10 at Month 12 after the first IC51 vaccination (in study IC51-322)
Secondary Outcome Measures:
- GMT for JEV neutralizing antibodies measured using the PRNT at Month 12 after the first IC51 vaccination (in study IC51-322) [ Time Frame: Month 12 ] [ Designated as safety issue: No ]GMT for JEV neutralizing antibodies measured using the PRNT at Month 12 after the first IC51 vaccination (in study IC51-322)
- GMTs and rate of subjects with PRNT50 titers of ≥ 1:10 at Months 24 and 36 after the first IC51 vaccination (in study IC51-322) [ Time Frame: Month 24, 36 ] [ Designated as safety issue: No ]GMTs and rate of subjects with PRNT50 titers of ≥ 1:10 at Months 24 and 36 after the first IC51 vaccination (in study IC51-322)
- Rate of subjects with SAEs following immunization up to Months 12, 24 and 36 after the first IC51 vaccination (in study IC51-322) [ Time Frame: Months 12, 24 and 36 ] [ Designated as safety issue: Yes ]Rate of subjects with SAEs following immunization up to Months 12, 24 and 36 after the first IC51 vaccination (in study IC51-322)
- 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). Severity, duration and relationship to vaccinations. [ Time Frame: Months 12, 24 and 36 ] [ Designated as safety issue: Yes ]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). Severity, duration and relationship to vaccinations.
| Enrollment: | 23 |
| Study Start Date: | October 2010 |
| Estimated Study Completion Date: | March 2015 |
| Estimated Primary Completion Date: | March 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No treatment
subjects will be followed up on immunity (analysis of blood samples) and safety
|
Procedure: Blood draw
blood draw at Month 12, Month 24 and Month 36.
Biological: IC51 has given in the parent study IC51-322
No more vaccinations in IC51-324 since this a study for long-term follow-up on safety and immunogenicity after vaccinations in parent study IC51-322.
|
Eligibility| Ages Eligible for Study: | 9 Months to 20 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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 < 21 years at the time of enrolment into this study.
- Written informed consent by the subject, the subject's legal representative(s), according to local requirements, and written informed assent of the subject, if applicable.
Exclusion Criteria:
- History of or clinical manifestation of any Flavivirus disease during study IC51‐322.
- Vaccination against JE virus (JEV) (except with IC51) at any time prior or planned during this study.
- Participation in another study with an investigational product during study IC51‐322 or IC51‐324.
- History of or development of any immunodeficiency including post‐organtransplantation after inclusion into study IC51‐322.
- History of or development of an autoimmune disease during study IC51‐322.
- Administration of chronic (defined as more than 14 days) immunosuppressants or other immune‐modifying medications started during study IC51‐322 up to first visit of study IC51‐324. (For corticosteroids this means prednisone or equivalent at >= 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).
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01246479
Locations
| United States, Florida | |
| Tampa, Florida, United States | |
| United States, Massachusetts | |
| Boston, Massachusetts, United States | |
| United States, New York | |
| NYC, New York, United States | |
| Australia | |
| Bisbane, Australia | |
| Melbourne, Australia | |
| Germany | |
| Berlin, Germany | |
| Hamburg, Germany | |
Sponsors and Collaborators
Intercell AG
Investigators
| Study Chair: | Andrea Ayad |
More Information
No publications provided
| Responsible Party: | Intercell AG |
| ClinicalTrials.gov Identifier: | NCT01246479 History of Changes |
| Other Study ID Numbers: | IC51-324 |
| Study First Received: | October 6, 2010 |
| Last Updated: | February 1, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Encephalitis Encephalitis, Japanese Central Nervous System Viral Diseases Virus Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Central Nervous System Infections Encephalitis, Arbovirus Arbovirus Infections Encephalitis, Viral RNA Virus Infections Flavivirus Infections Flaviviridae Infections |
ClinicalTrials.gov processed this record on May 22, 2013