Phase 3
N=192
Concomitant Vaccination With the Japanese Encephalitis Vaccine IC51 and HARVIX® 1440
Japanese Encephalitis
Bottom Line
View on ClinicalTrials.gov: NCT00596271 ↗Enrolled (actual)
192
Serious AEs
0.5%
Results posted
May 2014
Primary outcome: Primary: Geometric Mean Titer (GMT) at Day 56 for Anti-JEV Neutralizing Antibodies — 192.2; 202.7 titers — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- IC51 (Biological); HAVRIX (Biological); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Valneva Austria GmbH
- Primary completion
- Jul 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Geometric Mean Titer (GMT) at Day 56 for Anti-JEV Neutralizing Antibodies |
192.2; 202.7 | <0.0001 sig |
| PRIMARY GMT for Hepatitis A Virus (HAV) Antibody at Day 28 |
21.7; 24 | <0.0001 sig |
| SECONDARY Seroconversion Rate (SCR) at Day 56 for Plaque Reduction Neutralization Assay (PRNT) and HAV at Day 28 |
— | — |
| SECONDARY GMT and SCR for PRNT at Day 28 and HAV at Day 56 |
— | — |
| SECONDARY Safety |
— | — |
Summary
The objective is to investigate the immunogenicity of the Japanese Encephalitis vaccine IC51 (JE-PIV) single and concomitant with HAVRIX® 1440
Eligibility Criteria
Inclusion Criteria
- At least 18 years of age
- In female subjects either childbearing potential terminated by surgery or one year post-menopausal, or a negative serum pregnancy test during screening and the willingness not to become pregnant during the study period and 30 days after the last vaccination by practicing reliable methods of contraception
- Written informed consent obtained prior to study entry
Exclusion Criteria
- History of clinical manifestation of any flavivirus infection
- History of vaccination against Japanese encephalitis (JE), Yellow fever and Dengue fever (an anti-JEV neutralizing antibody titer >= 1:10 at baseline is acceptable for inclusion, these subjects will be part of the safety population, but will not be analyzed for immunogenicity in the per-protocol analysis)
- History of any previous Hepatitis A vaccination and infection
- Use of any other investigational or non-registered drug or vaccine in addition to the study vaccine during the study period or within 30 days preceding the first dose of study vaccine
- Planned administration of another vaccine during the study period
- Immunodeficiency including post-organ-transplantation or immunosuppressive therapy
- A family history of congenital or hereditary immunodeficiency
- History of autoimmune disease
- Administration of chronic (defined as more than 14 days) immunosuppressants or other immune-modifying drugs within six months of vaccination.
- Any acute infections within 4 weeks prior to enrollment
- Infection with human immunodeficiency virus (HIV), Hepatitis B (HBsAg) or Hepatitis C
Data sourced from ClinicalTrials.gov (NCT00596271). 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.