Immunogenicity Study of the Japanese Encephalitis Vaccine IC51

Japanese Encephalitis Clinical Trial

Official title:

Observer Blinded, Randomized Phase 3 Study to Investigate the Non-Inferiority of IC51 vs. JE-VAX as Vaccines for Japanese Encephalitis in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00604708
• Other study ID #: IC51-301
• Status: Completed
• Phase: Phase 3
• Start date: September 2005
• Est. completion date: September 2006

Study information

• Verified date: March 2024
• Source: Valneva Austria GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 867
• Est. completion date: September 2006
• Est. primary completion date: September 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Encephalitis
• Encephalitis, Japanese
• Japanese Encephalitis

Intervention

Biological:
• IC51
IC51 (JE-PIV), 6 mcg, i.m. injection, 2 vaccinations, days 0 and 28
• JE-VAX
JE-VAX, 1mL s.c. injection, 3 vaccinations, days 0, 7 and 28

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Valneva Austria GmbH

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SCR (Seroconversion Rate)of IC51 Compared to JE-VAX at Day 56	SCR: anti-JEV neutralizing antibody titer =1:10	Day 56
Primary	GMT (Geometric Mean Titer) of IC51 Compared to JE-VAX at Day 56	GMT: geometric mean of PRNT50	Day 56
Secondary	Safety and Adverse Events		until Day 56
Secondary	Immunogenicity at Day 28		Day 28
Secondary	Immunogenicity at Day 56 for North America vs. Europe		Day 56
Secondary	Immunogenicity at Day 56 for Subjects Older vs. Younger Than 50 Years of Age		Day 56