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

Valneva

Status and phase: Completed; Phase 3

Conditions: Japanese Encephalitis

Treatments: Biological: HAVRIX; Biological: IC51; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00596271

IC51-308

Details and patient eligibility

About

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

Full description

This is a randomized, controlled, multi-center, single-blind phase 3 study. The study population consists of male and female healthy subjects, aged at least 18 years.

192 subjects will be enrolled at 2 sites in Europe.

Enrollment: 192 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

192 participants in 3 patient groups

IC51 and Placebo

Active Comparator group

Description:

6 mcg i.m. IC51 with 2 injections (day 0 and 28)and placebo 0.5 mL with 1 injection (day 0)

Treatment:

Other: Placebo

Biological: IC51

HAVRIX and placebo

Active Comparator group

Description:

HAVRIX with 1 injection (day 0) and placebo 0.5 mL with 2 injections (day 0 and 28)

Treatment:

Biological: HAVRIX

Other: Placebo

IC51 and HAVRIX

Active Comparator group

Description:

IC51 6 mcg i.m. with 2 injections (day 0 and 28) and HAVRIX with 1 injection (day 0)

Treatment:

Biological: HAVRIX

Biological: IC51