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

NCT00596271 | Completed Phase 3 Results

• 1 other identifier: IC51-308
• Study Type: interventional
• Target: 192
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Japanese Encephalitis

Outcome Measures

Primary Outcomes (2)

• Geometric Mean Titer (GMT) at Day 56 for Anti-JEV Neutralizing Antibodies

  anti-JEV Neutralizing Antibodies were tabulated for IC51 groups only; for HAV GMTs (co-primary endpoint GMT for Hepatitis A Virus (HAV) Antibody at Day 28), please refer to "Outcome 2" within outcome measure section

  Day 56

• GMT for Hepatitis A Virus (HAV) Antibody at Day 28

  Day 28

Secondary Outcomes (3)

• Seroconversion Rate (SCR) at Day 56 for Plaque Reduction Neutralization Assay (PRNT) and HAV at Day 28

  day 28 and 56

• GMT and SCR for PRNT at Day 28 and HAV at Day 56

  day 28 and 56

• Safety

  until 6 month after last vaccination

Study Arms (3)

IC51 and Placebo

ACTIVE COMPARATOR

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

Biological: IC51; Other: Placebo

HAVRIX and placebo

ACTIVE COMPARATOR

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

Biological: HAVRIX; Other: Placebo

IC51 and HAVRIX

ACTIVE COMPARATOR

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

Biological: IC51; Biological: HAVRIX

Interventions

IC51 BIOLOGICAL

Also known as: Japanese Encephalitis purified inactivated vaccine

IC51 and HAVRIX; IC51 and Placebo

HAVRIX BIOLOGICAL

HAVRIX and placebo; IC51 and HAVRIX

Placebo OTHER

HAVRIX and placebo; IC51 and Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• History of clinical manifestation of any flavivirus infection
• 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

Sponsors & Collaborators

• Valneva Austria GmbH: lead

MeSH Terms

Conditions

Encephalitis, Japanese

Interventions

Hepatitis A Vaccines

Condition Hierarchy (Ancestors)

Encephalitis, Arbovirus; Encephalitis, Viral; Central Nervous System Viral Diseases; Central Nervous System Infections; Infections; Infectious Encephalitis; Arbovirus Infections; Vector Borne Diseases; Mosquito-Borne Diseases; Virus Diseases; RNA Virus Infections; Flavivirus Infections; Flaviviridae Infections; Encephalitis; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neuroinflammatory Diseases

Intervention Hierarchy (Ancestors)

Viral Hepatitis Vaccines; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: Katrin Dubischar-Kastner
• Organization: Valneva Austria GmbH

info@valneva.com

+43 1 206 20

Study Officials

• Astrid Kaltenboeck, Ph.D.

  Valneva Austria GmbH

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2008
• First Posted: January 16, 2008
• Study Start: September 1, 2005
• Primary Completion: July 1, 2006
• Study Completion: August 1, 2008
• Last Updated: May 13, 2014
• Results First Posted: May 13, 2014

Record last verified: 2014-04