Safety Study of ChimeriVax™-JE Vaccine to Prevent Japanese Encephalitis.

Japanese Encephalitis Clinical Trial

Official title:

Randomised, Double Blind, Multicentre, Placebo Controlled Phase III Study of the Safety and Tolerability Following Administration of Live Attenuated JE Vaccine (ChimeriVax™-JE)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00314132
• Other study ID #: H-040-010
• Status: Completed
• Phase: Phase 3
• First received: April 11, 2006
• Last updated: December 4, 2012
• Start date: October 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 assess whether ChimeriVax™ JE vaccine (a new vaccine to be used for vaccination against Japanese encephalitis) is safe and well tolerated when compared to placebo (dummy) vaccination.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2004
• Est. completion date: November 2006
• Est. primary completion date: November 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Informed consent obtained from the subject.

• Aged 18 years or above at screening.

• In good general health

• Subject available for the study duration

• For female subjects (of child bearing potential) a negative pregnancy tests at Screening and Day 0.

Exclusion Criteria:

• A history of vaccination against or infection with JE.

• Known or suspected immunodeficiency, use of immunosuppressive or antineoplastic drugs.

• History of thymoma, thymic surgery (removal) or myasthenia gravis.

• Clinically significant abnormalities on laboratory assessment

• Anaphylaxis or other serious adverse reactions characterised by urticaria or angioedema to foods, Hymenoptera (bee family) stings, or drugs including vaccines).

• Transfusion of blood or treatment with any blood product, including intramuscular or intravenous serum globulin within six months of the Screening Visit or up to Day 30.

• Administration of another vaccine or antiviral within 30 days preceding the Screening visit or up to Day 30.

• Physical examination indicating any clinically significant medical condition.

• Oral temperature >38°C (100.4°F) or acute illness within 3 days prior to inoculation.

• Intention to travel out of the area for an extended period that may affect the subjects ability to attend clinic visits prior to the study visit up to Day 30.

• Seropositive to hepatitis C virus (HCV) or HIV or positive for Hepatitis B Surface Antigen.

• Lactation or intended pregnancy in female subjects.

• Excessive alcohol consumption, drug abuse, significant psychiatric illness.

• A known or suspected physiological or structural condition that compromises the integrity of the blood-brain barrier (e.g. cerebrovascular disease, multiple sclerosis, trauma, infection, inflammation of the brain or meninges).

• Participation in another clinical study within 30 days of the screening visit for this study.

• Employee of the study site, Sponsor or Clinical Research Organization (CRO) involved with the management of the study.

• Any other reasons, which in the investigator's opinion, makes the subject unsuitable to participate in the study.

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, Japanese Encephalitis vaccine
0.5 mL, Subcutaneous
• 0.9% Saline
0.5 mL, Subcutaneous

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 Reporting Treatment Related Adverse Events Post Vaccination With Either ChimeriVax™-JE or a Placebo	Adverse events were collected by means of diary cards and scripted interviews. All adverse events reporting was considered "actively solicited" through Day 30.	Day 0 up to 30 days post-vaccination	No
Primary	Number of Participants Reporting Treatment Emergent Local Adverse Reactions and Treatment Emergent Systemic Reactions Post-vaccination With Either ChimeriVax™-JE or a Placebo	Treatment emergent local adverse reactions: Injection Site Pain, Itching, Erythema, Swelling, Induration, Skin Rash, and others as reported.; Treatment emergent systemic reactions: Malaise, Headache, Myalgia, Feeling Hot, Chills, Fatigue, Dyspnea, Wheezing, Nausea, Vomiting, Diarrhea, Abdominal Pain and others as reported.	Day 0 up to 30 days post-vaccination	No