Cancer Clinical Trial
Official title:
Randomized Controlled Trial to Compare Seroprotection Rate According to Timing of Influenza Vaccination in Adult Patients With Non-Hematologic Malignancies Receiving Scheduled Cytotoxic Chemotherapy
The purpose of this study is to determine the timing of influenza vaccination to induce higher antibody response in adult patients with non-hematologic malignancies receiving scheduled cytotoxic chemotherapy.
The participants will be stratified by the age (cut off; 60 years old) and last year
influenza vaccination, and block-randomized to 2 groups; Day 1 vaccination group and Day 11
vaccination group.
Day 1 group will be vaccinated at Day 1, when the cycle of chemotherapy begins. Day 11 group
will get the vaccine at Day 11, 10 days after chemotherapy begins.
As the rate of completion of study in the Day 11 group is anticipated lower than Day 1
group, we will assign the participants into Day 1: Day 11 with the different ratio; 4:5.
Hemagglutination inhibition Ab titre at pre-vaccination and post-vaccination (21-28 days
after vaccination) will be examined in all participants.
All the participants will be asked if they have any contraindication for influenza vaccine
by a physician before vaccination. And they will be monitored for any adverse reaction of
the vaccination after 2-4 days(phone calling) and after 21-28 days (visiting the hospital).
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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