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

NCT ID: NCT00319592

Last Updated: 2012-08-20

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-05-31

Study Completion Date

2006-09-30

Brief Summary

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The purpose of this study is to determine non-inferiority in seroconversion and to compare the safety and tolerability between ChimeriVax™-JE and JE-VAX® to the respective homologous virus strain and several wild types strains after completion of vaccination course.

Detailed Description

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Conditions

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Japanese Encephalitis

Keywords

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Japanese encephalitis ChimeriVax™-JE JE-VAX®

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ChimeriVax™-JE

Subjects received 2 injections of placebo (normal saline), 1 each on Days 0 and 7, and 1 injection of ChimeriVax™-JE on Day 28.

Group Type EXPERIMENTAL

ChimeriVax™-JE vaccine

Intervention Type BIOLOGICAL

0.5 mL, subcutaneously

JE-VAX®

Subjects received 1 injection of JE-VAX® each on Days 0, 7, and 28.

Group Type ACTIVE_COMPARATOR

JE-VAX® vaccine

Intervention Type BIOLOGICAL

1.0 mL, subcutaneously

Interventions

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ChimeriVax™-JE vaccine

0.5 mL, subcutaneously

Intervention Type BIOLOGICAL

JE-VAX® vaccine

1.0 mL, subcutaneously

Intervention Type BIOLOGICAL

Other Intervention Names

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ChimeriVax™-JE JE-VAX®

Eligibility Criteria

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Inclusion Criteria

* Written informed consent obtained.
* Aged ≥18 to \<49 years.
* In good general health.
* Available for the study duration, including all planned follow-up visits.
* Females must have negative pregnancy test and be using adequate form of contraception

Exclusion Criteria

* Clinically significant abnormalities on laboratory and vital sign assessments.
* Anaphylaxis or other serious adverse reactions
* Administration of another vaccine within 30 days of study treatment period.
* Physical examination indicating any significant medical condition.
* Intention to travel out of the area prior to the study visit on Day 56.
* Seropositive to Hepatitis C Virus (HCV) or Human Immunodeficiency Virus (HIV) or positive for Hepatitis B Surface Antigen.
* Pregnancy.
* Excessive alcohol consumption, drug abuse.
* Involvement in another clinical study within 60 days preceding the screening visit and during study treatment period.
Minimum Eligible Age

18 Years

Maximum Eligible Age

48 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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PRA Health Sciences

INDUSTRY

Sponsor Role collaborator

Sanofi

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nancy L Abdou, MD

Role: PRINCIPAL_INVESTIGATOR

PRA Health Sciences

Locations

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Clinical Pharamacology Center

Lenexa, Kansas, United States

Site Status

Countries

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United States

Other Identifiers

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H-040-008

Identifier Type: -

Identifier Source: org_study_id