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A Long-Term Study of Healthy Adults Vaccinated With One Dose of Smallpox Vaccine (LISTER Strain)

NCT ID: NCT00998543

Last Updated: 2012-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

147 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-10-31

Study Completion Date

2012-03-31

Brief Summary

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The purpose of this study is to provide long-term follow-up immunogenicity and safety data on participants who were vaccinated with the second-generation smallpox vaccine in Study VVL04 (NCT 00258947).

Primary Objectives:

Immunogenicity: To yearly describe the vaccinia antibody persistence up to 5 years post-vaccination.

Safety: To follow-up the long-term safety up to 5 years post-vaccination.

Detailed Description

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None of the participants in this study will receive any vaccination as part of the study. All participants will provide blood samples for immunogenicity testing at the 1, 2, 3, 4, and 5 year anniversaries of vaccination. Safety will be assessed for up to 5 years after vaccination, including follow-up of reactions that occurred during Study VVL04 (NCT 00258947).

Conditions

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Smallpox

Keywords

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Smallpox Vaccinia Virus Smallpox Vaccine Variola Virus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Smallpox Vaccine (LISTER Strain) Group

Participants were vaccinated with the second-generation smallpox vaccine in Study VVL04 (NCT 00258947).

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Subject vaccinated and who completed the Phase II VVL04 trial.
* Informed consent form signed.
* Subject able to comply with all trial procedures.
* Subject entitled to national social security.

Exclusion Criteria

* Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.
Minimum Eligible Age

18 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sanofi

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Sanofi Pasteur Inc.

Locations

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Gières, , France

Site Status

Lagord, , France

Site Status

Montpellier, , France

Site Status

Paris, , France

Site Status

Poitiers, , France

Site Status

Countries

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France

Related Links

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http://www.sanofipasteur.com

Related Info

Other Identifiers

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VVL05

Identifier Type: -

Identifier Source: org_study_id