Phase 3
N=300
Open-label, Randomized Study in a Pediatric Population in a JEV (Japanese Encephalitis Virus)-Endemic Country
Japanese Encephalitis
Bottom Line
View on ClinicalTrials.gov: NCT01296360 ↗Enrolled (actual)
300
Serious AEs
3.3%
Results posted
Dec 2014
Primary outcome: Primary: SCRs (Seroconversion Rate) as Defined by Percentage of Subjects With Plaque Reduction Neutralization Test Titers of>1:10 at 1 Month After the Booster Dose — 100; 100 percentage of subjects
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- IXIARO (Biological)
- Age
- Pediatric, Adult · 0+ yrs
- Sex
- All
- Sponsor
- Valneva Austria GmbH
- Primary completion
- Nov 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY SCRs (Seroconversion Rate) as Defined by Percentage of Subjects With Plaque Reduction Neutralization Test Titers of>1:10 at 1 Month After the Booster Dose |
100; 100 | — |
| SECONDARY Rate of Subjects Achieving a >4-fold Increase in JEV (Japanese Encephalitis Virus) Neutralizing Antibody Titers at 1 Month After the Booster Dose |
— | — |
| SECONDARY GMTs (Geometric Mean Titre) for JEV Neutralizing Antibodies Measured Using a Validated PRNT (Plaque Reduction Neutralization Test) at 1 Month After the Booster Dose |
— | — |
| SECONDARY GMTs and Rate of Subjects With a PRNT Titer of >1:10 at Months 12, 24 and 36 After First IXIARO Vaccination in IC51-323 With and Without Booster Vaccination |
— | — |
| SECONDARY Rate of Subjects With SAEs (Serious Adverse Events) Following Immunization and Medically Attended AEs (Adverse Events) up to Months 12, 24 and 36 After the First IXIARO Vaccination in IC51 323 With and Without Booster Vaccination. Severity, Duration and |
— | — |
| SECONDARY Rate of Subjects With Unsolicited AEs (Adverse Events) up to Months 12, 24 and 36 After the First IXIARO Vaccination in IC51 323 With and Without Booster Vaccination. Severity, Duration and Relationship to Vaccinations. |
— | — |
| SECONDARY Rate of Subjects With SAEs and Medically Attended AEs Within 1 Month Following the Booster Dose. Severity, Duration and Relationship to Vaccinations. |
— | — |
| SECONDARY Rate of Subjects With Unsolicited AEs Within 1 Month Following the Booster Dose. Severity, Duration and Relationship to Vaccinations. |
— | — |
| SECONDARY Rate of Subjects With Solicited AEs for up to 7 Days Following the Booster Dose. Severity and Duration. |
— | — |
Summary
This is a randomized, open-label Phase 3 study including children aged >9 months to <17 years and 7 months who have been vaccinated with IXIARO in study IC51-323.
Eligibility Criteria
Inclusion Criteria
- Children and adolescents who have completed study IC51-323 and received both IXIARO vaccinations according to protocol.
- Children who have received the dose confirmed for their age group.
- Male or female healthy children and adolescents aged ≥9 months to 0.05 mg/kg/day; topical and inhaled steroids are allowed).
- Acute febrile infection at Visit 2 (only for the Booster Group).
- Pregnancy (positive pregnancy test at Visit 1 and Visit 2), lactation or unreliable contraception in female subjects after onset of menarche.
- Hypersensitivity reactions to IXIARO or adverse events in study IC51-323 requiring withdrawal from further vaccination or anaphylaxis or severe cases of atopy requiring emergency treatment or hospital admission during IC51-323 or IC51 325.
- History of urticaria after hymenoptera envenomation, drugs, physical or other provocations or of idiopathic cause during IC51-323 or IC51 325.
- Known infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) (measurement of Hepatitis B surface antigen [HBsAg] titers) or hepatitis C virus (HCV).
- Illicit drug use 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 have been committed to an institution (by a court or by an authority).
Data sourced from ClinicalTrials.gov (NCT01296360). 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.