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Immunogenicity Study of the Japanese Encephalitis Vaccine IC51

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Valneva

Status and phase

Completed
Phase 3

Conditions

Japanese Encephalitis

Treatments

Biological: IC51
Biological: JE-VAX

Study type

Interventional

Funder types

Industry

Identifiers

NCT00604708
IC51-301

Details and patient eligibility

About

The objective is to demonstrate the non-inferiority of the Japanese Encephalitis vaccine IC51 compared to JE-VAX in healthy subjects aged > or = 18 years

Enrollment

867 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • At least 18 years of age
  • 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)
  • 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
  • Immunodeficiency including post-organ-transplantation or immunosuppressive therapy
  • A family history of congenital or hereditary immunodeficiency
  • History of autoimmune disease
  • Any acute infections within 4 weeks prior to enrollment
  • Infection with HIV, Hepatitis B or Hepatitis C
  • Pregnancy, lactation or unreliable contraception in female subjects

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

867 participants in 2 patient groups

IC51
Experimental group
Description:
6 mcg (microgram) i.m. (intramuscular) on Day0, 14 and 28
Treatment:
Biological: IC51
JE-VAX
Active Comparator group
Description:
given s.c. on Day 0, 7 and 28
Treatment:
Biological: JE-VAX

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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