NCT03590808

Influenza Vaccination in Patients Receiving Immune Checkpoint Inhibitor

Efficacy and Safety of Influenza Vaccine in Cancer Patients Receiving Immune Checkpoint Inhibitor

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 143 (actual)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to elucidate efficacy and safety of influenza vaccine in cancer patients receiving immune checkpoint inhibitor.

Detailed description

* Solid cancer patients receiving immune checkpoint inhibitor or cytotoxic chemotherapy will be recruited 1:2 manner in two hospitals. Target numbers are 48 and 95, respectively. * All the participants will be vaccinated for influenza during their chemotherapy when they meet inclusion criteria. * All the participants will be asked if they have any contraindication for influenza vaccine by a physician before vaccination. * Hemagglutination inhibition Ab titre at pre-vaccination and post-vaccination (21-35 days after vaccination) will be examined in all participants to examine seroprotection rates, seroconversion rates, and changes in geometric mean titer. * And they will be monitored for any vaccination-related adverse reaction or immune-related adverse events after 2-4 days(via phone call), and till 6 months after vaccination (when they visit oncology clinics).

Conditions

• Influenza
• Solid Carcinoma

Interventions

Type	Name	Description
BIOLOGICAL	Influenza vaccination	Purified inactivated influenza virus antigen (Green Cross Corp) 0.5 mL once IM

Timeline

• Start date: 2018-09-01
• Primary completion: 2018-12-21
• Completion: 2019-05-30
• First posted: 2018-07-18
• Last updated: 2019-09-19

Locations

1 site across 1 country: South Korea