None listed
Conditions
Interventions
Drug : Prevenar 13 (Prevenar) 1 ample, intramuscular injection,
2 weeks before chemotherapy vs. vaccinated on the day of chemotherapy
Sponsors
Chonnam National University Hospital Hwasun Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Eligible patients (aged = 19 years) had underwent surgical resection for primary gastric or colorectal cancer and scheduled for adjuvant chemotherapy (fluoropyrimidine ± oxaliplatin), an Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less, and adequate hematological, renal, hepatic function within 2 weeks of randomization (absolute neutrophil count =1,500/mm3, platelet count =100,000/mm3, serum creatinine = 1.5 X the upper limit of normal [ULN] or estimated glomerular filtration rate [eGFR] > 50 mL/min calculated by Cockcroft-Gault equation, serum aspartate aminotransferase [AST] and alanine aminotransferase [ALT] = 3 X the ULN, and total bilirubin = 2 X the ULN).
Exclusion criteria
Exclusion criteria: Exclusion criteria included previous pneumococcal vaccination, hypersensitivity to diphtheria toxin or other compounds of the vaccine, history of immunodeficiency disorders or autoimmune diseases, use of immunomodulatory drugs within 3 months of randomization, and signs of infection within 24 hours of vaccination.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| immunogenicity of vaccination | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety of vaccination | — |
Countries
Korea, Republic of
Contacts
Public ContactWoo Kyun Bae
Chonnam National University Hospital Hwasun Hospital
Outcome results
None listed