Immunogenicity, Safety, and Tolerability of an MF59-Adjuvanted Versus Non-Adjuvanted Influenza Vaccines in Patients With Chronic Pulmonary Disease, Chronic Heart Disease, or Diabetes Mellitus

Inclusion Criteria

• •For Subjects with Chronic Diseases:
• •Subjects between 18 and 70 years of age (inclusive)
• •Any sex or ethnicity
• •Outpatient or hospitalized subjects
• •Confirmed diagnosis of chronic pulmonary and/or cardiac, and/or diabetes mellitus based on the investigator's assessment (subjects may present one or more of such conditions)
• •Childbearing potential women must be willing to use an acceptable contraceptive method. Acceptable contraceptive methods are defined as one or more of the following:
• •1. Hormone contraceptive (such as oral, injectable, transdermal patch, subcutaneous implant, cervical ring)
• •2. Barrier (condom with spermicide or diaphragm with spermicide) at each intercourse and during the whole intercourse
• •3. Intra-uterine device (IUD)
• •4. Monogamous relation with vasectomized partner (must have been vasectomized at least six months before the volunteer entered the study)
• •Subjects capable of following all the study procedures and available for all visits scheduled to the investigation site
• •Subjects capable of understanding the nature and risk of the study proposed and sign the consent form
• •The study subjects may have other underlying chronic diseases that do not involve immunosuppression (e.g. osteoarticular diseases, stable, non-progressive, non-severe neurologic disorders without cognitive impairment, ophthalmologic diseases, hypothyroidism, etc.), but their symptoms/signs must be under control through medical follow-ups and drug therapy
• •For Healthy Subjects:
• •Subjects between 18 and 70 years of age (inclusive)
• •Any sex and ethnicity
• •Subjects with good health as determined by medical history, physical evaluation, and investigator's clinical opinion
• •Childbearing potential women must be willing to use an acceptable contraceptive method. Acceptable contraceptive methods are defined as one or more of the following:
• •1. Hormone contraceptive (such as oral, injectable, transdermal patch, subcutaneous implant, cervical ring)
• •2. Barrier (condom with spermicide or diaphragm with spermicide) at each intercourse and during the whole sexual intercourse
• •3. Intra-uterine device (IUD)
• •4. Monogamous relation with vasectomized partner (must have been vasectomized for at least six months before the volunteer entered the study)
• •Subjects capable of respecting all the study procedures and available for all the visits scheduled at the investigation site
• •Subjects capable of understanding the nature and risk of the study proposed and sign the consent form