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Phase 3 Completed N=192 Randomized Single-blind Prevention

Concomitant Vaccination With the Japanese Encephalitis Vaccine IC51 and HARVIX® 1440

Source: ClinicalTrials.gov NCT00596271 ↗
Enrolled (actual)
192
Serious AEs
0.5%
Results posted
May 2014
Primary outcomePrimary: Geometric Mean Titer (GMT) at Day 56 for Anti-JEV Neutralizing Antibodies — 192.2; 202.7 titers — p=<0.0001

Summary

The objective is to investigate the immunogenicity of the Japanese Encephalitis vaccine IC51 (JE-PIV) single and concomitant with HAVRIX® 1440

Outcome Measures

OutcomeResultp-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
— —

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
View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.

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