Evaluation of Take and Safety of a Smallpox Vaccine in Healthy Young Adults

January 30, 2012 updated by: Sanofi

Take Evaluation and Safety of Smallpox Vaccine (LISTER Strain) in Naïve Healthy Adults.

Primary Objective:

To estimate the smallpox vaccination take rate in healthy young adults not previously vaccinated with a smallpox vaccine.

Secondary Objectives:

To describe antibody response to vaccination and evaluate the take for each subject at various timepoints for each batch and pooled batches and to evaluate local signs, symptoms, and overall safety in healthy young adults not previously vaccinated with a smallpox vaccine.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

230

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Gieres, France
      • Lagord, France
      • Montpellier, France
      • Paris, France
      • Poitiers, France
      • Rouen, France

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 25 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Aged 18 to 25 years on the day of screening
  • Informed consent form signed
  • Able to attend all scheduled visits and to comply with all trial procedures
  • For a woman, inability to bear a child or negative serum pregnancy test performed at screening (Visit 01)
  • Subject entitled to national social security
  • Subject registered in the French file of healthy volunteers in clinical trials
  • For a woman of child-bearing potential: use of an effective method of contraception (hormonal or barrier method) from at least 3 months prior to screening to 3 months following trial vaccination
  • For a woman, inability to bear a child or negative urine pregnancy test.

Exclusion Criteria:

  • Previous smallpox vaccination confirmed by vaccination record or typical scar
  • Participation in another trial in the 3 months before or during the trial period
  • Acute intercurrent or chronic illness during the trial
  • Breast-feeding
  • Allergy or sensitivity to any known components of vaccinia immune globulin or previous reaction to immunoglobulins or trial vaccine
  • Congenital or acquired immunodeficiency or immunosuppressive therapy or any treatment including corticosteroids
  • Treatment with antiviral drugs within 1 month before vaccination
  • History of organ or bone marrow transplant or skin disorders
  • Personal or family history of autoimmune disease or cardiac disease, including cardiac risk factors
  • History or current central nervous system disease
  • Ongoing acute infectious disease
  • Blood or blood-derived products received in the past 6 months
  • Any vaccination with a live-attenuated vaccine within the 60 days or other vaccines within 40 days preceding the trial vaccination
  • Vaccination planned in the 8 weeks following the trial vaccination
  • Planned or foreseeable close contact after vaccination with infants less than 12 months, or with immuno-suppressed persons, pregnant and/or lactating woman, or practice of contact or water sports after vaccination before the crust separates
  • Skin wound near the vaccination site
  • Apparent lack of personal hygiene
  • Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent
  • HIV, hepatitis B or hepatitis C seropositivity (screening tests)
  • Abnormal lab values for hematological parameters or cardiac enzyme (screening tests)
  • Feverish illness (oral temperature >=37.5°C, rectal equivalent temperature >=38.0°C) on the day of vaccination.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Primary Completion (ACTUAL)

December 1, 2006

Study Completion (ACTUAL)

January 1, 2007

Study Registration Dates

First Submitted

November 24, 2005

First Submitted That Met QC Criteria

November 24, 2005

First Posted (ESTIMATE)

November 28, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

February 1, 2012

Last Update Submitted That Met QC Criteria

January 30, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VVL04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe