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A Randomized, Double-Blind, Placebo-Controlled Phase II Study to Evaluate Safety and Immunogenicity of One and Two Doses of IMVAMUNE® Smallpox Vaccine in 56-80 Year Old Vaccinia-Experienced Subjects
Enrollment
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Volunteers
Inclusion criteria
Male and female subjects 56-70 years of age. If no safety concerns are identified upon review of the safety data from the first 30 subjects enrolled, the age range is extended up to 80 years.
Time since most current smallpox vaccination > 10 years.
The subject has read, signed and dated the Informed Consent Form (ICF), successfully completed (at least 90% correct [no more than 3 attempts allowed]) the test of understanding and has signed the Health Insurance Portability and Accountability Act (HIPAA) authorization form.
Women must have a negative serum pregnancy test at screening and negative urine pregnancy test within 24 hours prior to vaccination.
Women of childbearing potential (WOCBP) must have used an acceptable method of contraception for 30 days prior to the first vaccination, must agree to use an acceptable method of contraception during the study and must not plan to become pregnant for at least 28 days after the last vaccination. (Acceptable contraception methods are restricted to abstinence, barrier contraceptives, intrauterine contraceptive devices or licensed hormonal products).
Weight: ≥ 100 pounds (45.5 kg) and ≤ 330 pounds (150 kg).
White blood cells ≥ 2500/mm3 and < 11,000/mm3.
Absolute neutrophil count within normal limits.
Hemoglobin within normal limits.
Platelets within normal limits.
Adequate renal function defined as:
Adequate hepatic function defined as:
Cardiac troponin I < 2 x ULN.
Electrocardiogram (ECG) without clinically significant findings, e.g. any kind of atrioventricular or intraventricular conditions or blocks such as complete left or right bundle branch block, AV node block, QTc or PR prolongation, sustained atrial arrhythmias, sustained ventricular arrhythmia, 2 premature ventricular contractions (PVC) in a row, ST elevation consistent with ischemia.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
120 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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