gB/MF59 Vaccine in Preventing Cytomegalovirus Infection in Healthy Adolescent Females

Exclusion Criteria

• •Receipt of blood and/or blood products in the past 3 months
• •Known to be pregnant or lactating
• •Planning to become pregnant during the first 8 months of the study (Months 0-8);
• •Known previous infection with cytomegalovirus (CMV);
• •Previously received a CMV vaccine;
• •History of allergic reactions to any component of the study vaccine;
• •History of malignancy or have a confirmed or suspected immunodeficient condition, such as human immunodeficiency virus (HIV) infection;
• •History of current acute or chronic autoimmune disease;
• •History of ongoing clinically significant illness (diabetes, pulmonary, cardiovascular, hepatic or renal functional abnormality) as determined by medical history;
• •History of any neurologic disorders or seizures, with the exception of febrile seizures during childhood;
• •Presently receiving or history of receiving any medications or treatments that affect the immune system such as immune globulin, interferon, immunomodulators, cytotoxic drugs or drugs known to be frequently associated with significant major organ toxicity, or systemic corticosteroids (oral or injectable) in the past 6 months. Inhaled and topical corticosteroids will be allowed;
• •History of depression not controlled with current drug therapy or involving institutionalization;
• •History of schizophrenia or psychosis;
• •History of suicide attempt;
• •Active substance or alcohol abuse;
• •Currently enrolled in another research study. (Subjects participating in a non-interventional studies, questionnaires, or observational studies will not be excluded from participation).
• •Antibodies to CMV that are detected at the screening visit;
• •Previously received a CMV vaccine;
• •Subject is planning on becoming pregnant during the first 8 months of the vaccine study;
• •Subject receives an experimental drug or vaccine in the 30 days prior to the first dose of vaccine or planned receipt before 30 days after the final dose of the vaccine;
• •Subject receives or is planning to receive a nonstudy vaccine within 30 days before or after any dose of study vaccine with the following exceptions: Administration of routine meningococcal, hepatitis A, hepatitis B, Tdap (Tetanus, Diphtheria, Pertussis), human papillomavirus (HPV), inactivated influenza (but not FluMist®), diphtheria/tetanus and/or diphtheria/tetanus-containing vaccine up to 8 days before or at least 8 days after a dose of study vaccine is allowed. Administration of vaccine injection can be delayed if a nonstudy vaccine has been administered and will be given as soon as acceptable;
• •Subject has an acute disease within 72 hours prior to enrollment in the vaccine study, defined as the presence of a moderate or severe illness (as determined by the investigator through medical history and physical examination. Study vaccine can be administered to persons with a minor illness, such as diarrhea, or mild upper respiratory tract infection with or without low-grade febrile illness. Vaccination can be delayed until the subject has recovered;
• •Subject receives systemic corticosteroids \> 2mg/kg for \>14 days. Inhaled and topical steroids are permitted.
• •None