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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00258947
First received: November 24, 2005
Last updated: January 30, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention Phase
Smallpox
Poxvirus Infection
Biological: Smallpox vaccine, LISTER strain, from chick embryo cells
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Take Evaluation and Safety of Smallpox Vaccine (LISTER Strain) in Naïve Healthy Adults.

Resource links provided by NLM:


Further study details as provided by Sanofi:

Enrollment: 230
Study Start Date: September 2005
Study Completion Date: January 2007
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 25 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00258947

Locations
France
Gieres, France
Lagord, France
Montpellier, France
Paris, France
Poitiers, France
Rouen, France
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Medical Director Sanofi Pasteur Inc
  More Information

Additional Information:
No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00258947     History of Changes
Other Study ID Numbers: VVL04
Study First Received: November 24, 2005
Last Updated: January 30, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Sanofi:
Smallpox
Orthopoxvirus
Poxvirus
Vaccina Virus
LISTER Strain
Bioterrorism

Additional relevant MeSH terms:
Poxviridae Infections
Smallpox
DNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on August 28, 2014