MedDataX Logo

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

NCT ID: NCT00314145

Last Updated: 2012-12-06

Study Results

Results available

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

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

820 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2006-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Japanese Encephalitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ChimeriVax™-JE

Participants received dose each of saline placebo on Days 0 and 7. On Day 30, participants received vaccinations of ChimeriVax™-JE vaccine and saline placebo into different arms.

Group Type EXPERIMENTAL

ChimeriVax™-JE

Intervention Type BIOLOGICAL

0.5 mL, Subcutaneous (ChimeriVax™-JE); 1.0 mL, (Saline)

JE-VAX®

Participants received 1 dose each of JE-VAX® vaccine on Days 0, 7, and 30, and a dose of saline placebo into a different arm on Day 30.

Group Type ACTIVE_COMPARATOR

JE-VAX®

Intervention Type BIOLOGICAL

0.5 mL, Subcutaneous (JE-Vax®); 1.0 mL, (Saline)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ChimeriVax™-JE

0.5 mL, Subcutaneous (ChimeriVax™-JE); 1.0 mL, (Saline)

Intervention Type BIOLOGICAL

JE-VAX®

0.5 mL, Subcutaneous (JE-Vax®); 1.0 mL, (Saline)

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Sanofi

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Luis Angles, M.D.

Role: PRINCIPAL_INVESTIGATOR

Heart of America Research Institute

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Chicago, Illinois, United States

Site Status

Shawnee Mission, Kansas, United States

Site Status

Missoula, Montana, United States

Site Status

Dallas, Texas, United States

Site Status

Tacoma, Washington, United States

Site Status

Adelaide, , Australia

Site Status

Melbourne, , Australia

Site Status

New South Wales, , Australia

Site Status

Queensland, , Australia

Site Status

Victoria, , Australia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Australia

References

Explore related publications, articles, or registry entries linked to this study.

Torresi J, McCarthy K, Feroldi E, Meric C. Immunogenicity, safety and tolerability in adults of a new single-dose, live-attenuated vaccine against Japanese encephalitis: Randomised controlled phase 3 trials. Vaccine. 2010 Nov 23;28(50):7993-8000. doi: 10.1016/j.vaccine.2010.09.035. Epub 2010 Oct 8.

Reference Type DERIVED
PMID: 20934459 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

H-040-009

Identifier Type: -

Identifier Source: org_study_id