A study to assess the immunogenicity and safety of PCV-13 during adjuvant chemotherapy
- Conditions
- Neoplasms
- Registration Number
- KCT0003379
- Lead Sponsor
- Chonnam National University Hospital Hwasun Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 92
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 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.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method immunogenicity of vaccination
- Secondary Outcome Measures
Name Time Method Safety of vaccination