search
Back to results

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

Primary Purpose

Smallpox, Poxvirus Infection

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Smallpox vaccine, LISTER strain, from chick embryo cells
Sponsored by
Sanofi
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Smallpox focused on measuring Smallpox, Orthopoxvirus, Poxvirus, Vaccina Virus, LISTER Strain, Bioterrorism

Eligibility Criteria

18 Years - 25 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 24, 2005
Last Updated
January 30, 2012
Sponsor
Sanofi
search

1. Study Identification

Unique Protocol Identification Number
NCT00258947
Brief Title
Evaluation of Take and Safety of a Smallpox Vaccine in Healthy Young Adults
Official Title
Take Evaluation and Safety of Smallpox Vaccine (LISTER Strain) in Naïve Healthy Adults.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
January 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smallpox, Poxvirus Infection
Keywords
Smallpox, Orthopoxvirus, Poxvirus, Vaccina Virus, LISTER Strain, Bioterrorism

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
230 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
Smallpox vaccine, LISTER strain, from chick embryo cells

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Sanofi Pasteur Inc
Official's Role
Study Director
Facility Information:
City
Gieres
Country
France
City
Lagord
Country
France
City
Montpellier
Country
France
City
Paris
Country
France
City
Poitiers
Country
France
City
Rouen
Country
France

12. IPD Sharing Statement

Links:
URL
http://www.sanofipasteur.com
Description
Related Info

Learn more about this trial

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

We'll reach out to this number within 24 hrs