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About
This is a phase III, randomized, controlled, open label study with two vaccine regimens. The study will assess the relative safety and immunogenicity of vaccine regimens comparing adjuvanted versus non-adjuvanted formulations of A(H1N1) inactivated influenza virus vaccine in subjects with Chronic Pulmonary Disease, Chronic Heart Disease, or Diabetes Mellitus, and to compare safety and immunogenicity data with a contemporaneously enrolled control group of age-comparable, healthy subjects.
Because certain individuals may be hypo-responsive to influenza vaccination, additional studies with high-risk groups are warranted in order to determine the optimal vaccine formulation and dosing schedule for prevention of novel H1N1 virus infection.
Enrollment
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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:
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:
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
Exclusion criteria
For Subjects with Chronic Diseases
For Healthy Subjects:
Primary purpose
Allocation
Interventional model
Masking
342 participants in 4 patient groups
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Data sourced from clinicaltrials.gov
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