A Safety and Efficacy Study of Two Japanese Encephalitis Vaccines ChimeriVax™-JE and JE-VAX

Japanese Encephalitis Clinical Trial

Official title:

A Multicentre, Randomized, Double-blind, Phase III Study of The Comparative Immunogenicity, Safety and Tolerability of Two Japanese Encephalitis Vaccines (ChimeriVax™-JE and JE-VAX®)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00314145
• Other study ID #: H-040-009
• Status: Completed
• Phase: Phase 3
• First received: April 11, 2006
• Last updated: December 4, 2012
• Start date: November 2005
• Est. completion date: November 2006

Study information

• Verified date: December 2012
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationAustralia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine non-inferiority in seroconversion and to compare the safety and tolerability between ChimeriVaxTM-JE and JE-VAX to the respective homologous virus strain after completion of vaccination course.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 820
• Est. completion date: November 2006
• Est. primary completion date: June 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subjects aged 18 or above

• Subjects in good general health.

• Females must have negative pregnancy test and be using adequate form of contraception

Exclusion Criteria:

• History of vaccination/infection with JE or Yellow fever or other flaviviruses

• History of residence/travel to flavivirus endemic regions

• History of anaphylaxis/serious adverse reactions

• Administration of vaccine within 30 days of study or during treatment period

• Clinically significant physical exam/medical history/lab abnormalities

• Pregnancy

• Excessive alcohol/drug abuse

• Hypersensitivity to constituents of JE-VAX®

• Blood transfusion/treatment with blood product within 6months of study and during study treatment period

• Known/suspected immunodeficiency

• Compromised blood brain barrier

• Employees of Clinical Research Organization (CRO)/study site staff

• Any other condition which would exclude subject.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Encephalitis
• Encephalitis, Japanese
• Japanese Encephalitis

Intervention

Biological:
• ChimeriVax™-JE
0.5 mL, Subcutaneous (ChimeriVax™-JE); 1.0 mL, (Saline)
• JE-VAX®
0.5 mL, Subcutaneous (JE-Vax®); 1.0 mL, (Saline)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Japanese Encephalitis (Homologous Virus) Seroconversion Following Either ChimeriVax™-JE or JE-Vax® Vaccination	Antibodies to Japanese encephalitis (JE) were measured by 50% plaque reduction neutralization test (PRNT50). Seroconversion was defined as a titer of = 1:10.	Up to Day 60 post-first vaccination	No
Primary	Number of Participants Reporting Treatment Emergent Local Adverse Events and Treatment Emergent Systemic Reactions Post-Vaccination With Either ChimeriVax™-JE or JE-Vax®	Treatment emergent local adverse events: Pain, Erythema, Pruritus, Swelling, Induration, and others as reported.; Treatment emergent systemic reactions: Fatigue, Malaise, Chills, Pyrexia, Headache, Myalgia, Arthralgia, Diarrhea, Nausea, Vomiting, and Rash.	Day 0 (Pre-vaccination) up to 60 days post-first vaccination	No
Secondary	Neutralizing Antibody Geometric Mean Titers (GMTs) to Japanese Encephalitis (Homologous Virus) Following Either ChimeriVax™-JE or JE-Vax® Vaccination	Antibodies to Japanese encephalitis (JE) were measured by 50% plaque reduction neutralization test (PRNT50).	Up to Day 60 post-first vaccination	No
Secondary	Number of Participants in the Japanese Encephalitis (Homologous Virus) Neutralizing Antibody Titer Categories on Day 60 Following Either ChimeriVax™-JE or JE-Vax® Vaccination	Antibodies to Japanese encephalitis (JE) were measured by 50% plaque reduction neutralization test (PRNT50).	Day 60 post-first vaccination	No