NCT00258947

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
230

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2005

Shorter than P25 for phase_2

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 24, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 28, 2005

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
Last Updated

February 1, 2012

Status Verified

January 1, 2012

Enrollment Period

1.2 years

First QC Date

November 24, 2005

Last Update Submit

January 30, 2012

Conditions

SmallpoxPoxvirus Infection

Keywords

SmallpoxOrthopoxvirusPoxvirusVaccina VirusLISTER StrainBioterrorism

Interventions

Smallpox vaccine, LISTER strain, from chick embryo cellsBIOLOGICAL

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Unknown Facility

Gières, France

Location

Unknown Facility

Lagord, France

Location

Unknown Facility

Montpellier, France

Location

Unknown Facility

Paris, France

Location

Unknown Facility

Poitiers, France

Location

Unknown Facility

Rouen, France

Location

Related Links

MeSH Terms

Conditions

SmallpoxPoxviridae Infections

Interventions

Smallpox Vaccine

Condition Hierarchy (Ancestors)

DNA Virus InfectionsVirus DiseasesInfections

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • Medical Director

    Sanofi Pasteur Inc

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 24, 2005

First Posted

November 28, 2005

Study Start

September 1, 2005

Primary Completion

December 1, 2006

Study Completion

January 1, 2007

Last Updated

February 1, 2012

Record last verified: 2012-01

Locations

FR(6)