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The purpose of this first time in human (FTiH) study is to evaluate the safety, reactogenicity and immunogenicity of several formulations of Respiratory Syncytial Virus (RSV) investigational vaccines in healthy men.
Full description
This protocol posting has been updated following protocol amendment 3 to amend the respective exclusion criterion as to only exclude subjects with clinically significant hematological/ biochemical abnormalities as per opinion of the investigator.
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Inclusion criteria
Exclusion criteria
Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the dose of study vaccine, or planned use during the study period.
Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product.
Planned administration/ administration of a vaccine not foreseen by the study protocol within the period starting 30 days before and ending 30 days after vaccination, with the exception of any licensed influenza vaccine which may be administered ≥ 15 days before or after vaccination.
Previous vaccination against RSV.
Chronic administration of immunosuppressants or other immune-modifying drugs within 6 months prior to the vaccine dose. Inhaled and topical steroids are allowed.
Administration of long-acting immune-modifying drugs at any time during the study period.
Administration of immunoglobulins and/or any blood products within the 3 months preceding the dose of study vaccine or planned administration during the study period.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
Family history of congenital or hereditary immunodeficiency.
History of or current autoimmune disease.
History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
Hypersensitivity to latex.
Any clinically significant hematological (hemoglobin level, white blood cell [WBC], lymphocyte, neutrophil, eosinophil and platelet count) and biochemical (alanine aminotransferase [ALT], aspartate aminotransferase [AST] and creatinine) abnormality as per the opinion of the investigator, based on the local laboratory normal ranges.
Any acute or chronic, clinically significant disease, as determined by physical examination or laboratory screening tests.
Malignancies within previous 5 years (excluding non-melanoma skin cancer) and lymphoproliferative disorders.
Current alcoholism and/or drug abuse.
Acute disease and/or fever at the time of Screening.
Planned move to a location that will prohibit participating in the trial until study end.
Any other condition that the investigator judges may interfere with study procedures (e.g. drawing blood) or findings (e.g. immune response).
Primary purpose
Allocation
Interventional model
Masking
128 participants in 8 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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