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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00053508 |
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Date of registration:
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30/01/2003 |
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Primary sponsor: |
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Public title:
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Dose Safety, Tolerability, and Immunogenicity of a New Smallpox Vaccine in Adults Without Previous Smallpox Vaccination
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Scientific title:
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The Effect of Dose On Safety, Tolerability, and Immunogenicity of ACAM1000 Smallpox Vaccine in Adults Without Previous Smallpox Vaccination A Phase 2, Randomized, Double-Blind, Dose-Response Study |
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Date of first enrolment:
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September 2002 |
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Target sample size:
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274 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT00053508 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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Countries of recruitment
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United States
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Contacts
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Name:
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Medical Director |
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Address:
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Telephone:
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Email:
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Affiliation:
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Sanofi Pasteur Inc |
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Key inclusion & exclusion criteria
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Inclusion criteria:
- in good general health.
- not pregnant and using effective birth control
- agreed to participate in entire study and comply with protocol requirements.
Exclusion criteria:
- military service prior to 1989.
- no previous smallpox vaccination.
- no contact with with children 1 year of age or younger
- immunodeficiency individuals or close contacts who are immunodeficient
- past history or current renal disease
- diagnosis or past history of eczema
- known allergy or past allergic reactions to latex gloves or to some antibiotics
(neomycin, streptomycin, chlortetracycline, and polymyxin B).
- known allergy or past allergic to blood products.
- known allergy or past allergic reaction to cidofovir or sulfa-containing drugs.
- transfusion of blood or treatment with any blood product, including intramuscular or
intravenous serum globulin within six months of the Screening Visit.
- serology positive for HIV, hepatitis B or hepatitis C.
- current diagnosis or history within six months of drug or alcohol abuse disorders,
psychiatric illness.
- inoculation with any other live vaccine within 30 days of Day 0 or participation in
another drug or vaccine trial within 30 days of Day 0.
Age minimum:
18 Years
Age maximum:
29 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Smallpox
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Intervention(s)
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Biological: ACAM1000
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Biological: vaccinia virus (calf lymph) smallpox vaccine: Dryvax
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Primary Outcome(s)
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The proportion of subjects in each treatment group who develop a major cutaneuos reaction on Day 7, Day 10, and/or Day 15.
[Time Frame: Day 7, Day 10, and/or Day 15]
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Secondary Outcome(s)
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1.The comparison of treatment groups for the proportion of subjects developing a >fourfold rise in neutralizing antibodies. 2. neutralizing antibody response. 3. geometric mean neutralizing titer on day 31 will be compared between treatment groups.
[Time Frame: days 0 and 30, day 31]
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Secondary ID(s)
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H-300-002
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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