Phase 3
N=1,869
Safety and Immunogenicity of the Japanese Encephalitis Vaccine IC51 (IXIARO®) in a Pediatric Population
Encephalitis
Bottom Line
View on ClinicalTrials.gov: NCT01041573 ↗Enrolled (actual)
1,869
Serious AEs
1.8%
Results posted
Feb 2014
Primary outcome: Primary: Rate of Subjects With Serious Adverse Events and Medically Attended Adverse Events Until Day 56 After First Vaccination — 16.1; 14.2; 38.2; 42.2 percentage of participants — p=0.641
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- IC51 Japanese Encephalitis (Biological); Havrix®720 (Biological); Prevnar (Biological)
- Age
- Pediatric, Adult · 0+ yrs
- Sex
- All
- Sponsor
- Valneva Austria GmbH
- Primary completion
- Feb 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Subjects With Serious Adverse Events and Medically Attended Adverse Events Until Day 56 After First Vaccination |
16.1; 14.2; 38.2; 42.2 | 0.641 |
| SECONDARY Geometric Mean Titers (GMT) for JEV Neutralizing Antibodies |
5.79; 9.78; 199.39; 190.77; 37.99; 64.83 | — |
| SECONDARY Seroconversion Rate (SCR) at Days 0, 56 and at Month 7 |
7.5; 33.6; 98.0; 100.0; 83.9; 94.5 | — |
| SECONDARY Rate of Subjects With SAEs and Medically Attended AEs |
0.5; 1.0; 0; 1.6; 16.1; 14.2 | — |
| SECONDARY Rate of Subjects With Solicited Local and Systemic AEs |
40.8; 29.4; 58; 59.4 | — |
| SECONDARY Rate of Subjects With Unsolicited AEs up to Day 56 and up to Month 7 |
46.5; 46.4; 72.5; 65.6; 58.5; 57.6 | — |
| SECONDARY Rate of Subjects With Abnormal Laboratory Parameters |
1; 1; 0; 0; 0; 2 | — |
Summary
The primary objective is to assess the systemic and local safety profile of purified inactivated Japanese Encephalitis Virus (JEV) vaccine IC51 administered in two doses in a 28 days interval up to Month 7 after the first IC51 vaccination in a pediatric population from endemic regions.
Eligibility Criteria
Inclusion Criteria
- Male or female healthy children and adolescents aged > 2 months to < 18 years at the time of first vaccination.
- Written informed consent by the subject's legal representative(s), according to local requirements, and written informed assent of the subject, if applicable.
- Female subjects: either no childbearing potential or negative pregnancy test, for females after menarche willingness to practice a reliable method of contraception.
Exclusion Criteria
- Clinical manifestation of Japanese Encephalitis
- History of Flavivirus vaccination (including any investigational vaccines)
- History of vaccination with HAVRIX®720 and/or Prevnar®
- History of immunodeficiency or immunosuppressive therapy
- Known HIV, HBV or HCV infection
- History of hypersensitivity reactions to other vaccines
- Acute febrile infection at each visit during which the subject receives a vaccination
- Active or passive immunization within 2 weeks prior to the first IC51 vaccination and up to the second IC51 vaccination.
Data sourced from ClinicalTrials.gov (NCT01041573). 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.