Seoul National University Hospital
Seoul, 110-744, South Korea
NCT Number: NCT03590808
The purpose of this study is to elucidate efficacy and safety of influenza vaccine in cancer patients receiving immune checkpoint inhibitor.
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Notify Me20 year and older
All sexes
Interventional
Not applicable
Seoul, 110-744, South Korea
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Purified inactivated influenza virus antigen (Green Cross Corp) 0.5 mL once IM
Time frame: 21 to 35 days after vaccination
The percentage of vaccine recipients with a serum haemagglutination inhibition(HI) titre ≥40 post vaccination (21-28 days)
Time frame: 21 to 35 days after vaccination
Seroconversion rate is defined as the percentage of vaccine recipients with a fourfold increase or more in post-vaccination HI titre
Time frame: 21 to 35 days after vaccination
Geometric mean titers of HI (haemagglutination inhibition) after vaccination
Time frame: 21 to 35 days after vaccination
The proportion of patients who experienced local or systemic adverse events related to vaccination
Time frame: 6 months after vaccination
The proportion of patients who experienced immune checkpoint inhibitor induced immune-related adverse events
Time frame: 21 to 35 days after vaccination
The levels of intracellular cytokines measured by flow cytometry
Seoul National University Hospital
Other
Efficacy and Safety of Influenza Vaccine in Cancer Patients Receiving Immune Checkpoint Inhibitor
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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