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  • Status : Approved
    • First Submitted Date : 2018/08/14
    • Registered Date : 2018/12/03
    • Last Updated Date : 2018/11/14
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1. Background

Background Information
CRIS
Registration Number
KCT0003379 
Unique Protocol ID CNUHH-2015-126 
Public/Brief Title A study to assess the immunogenicity and safety of PCV-13 during adjuvant chemotherapy 
Scientific Title A phase III study to assess the immunogenicity and safety of PCV-13 during adjuvant chemotherapy  
Acronym  
MFDS Regulated Study No
IND/IDE Protocol  
Registered
at Other Registry
No
Healthcare Benefit
Approval Status
Not applicable

2. Institutional Review Board/Ethics Committee

Institutional Review Board Information
Board Approval Status Submitted approval 
Board Approval Number CNUHH-2015-126 
Approval Date 2015-09-16 
Institutional Review Board  
Name Chonnam National University Hwasun Hospital Institutional Review Board 
Address 322 Seoyang-ro Hwasun-eup. Hwasun-gun Jeonnam, Korea 58128 
Telephone 061-379-7598 
Data Monitoring Committee    

3. Contact Details

Contact Details Information
Contact Person for Principal Investigator / Scientific Queries  
Name Woo Kyun Bae 
Title Associate Professor 
Telephone +82-61-379-7623 
Affiliation Chonnam National University Hospital Hwasun Hospital 
Address 322 Seoyang-ro Hwasun-eup. Hwasun-gun Jeonnam, Korea 58128 
Contact Person for Public Queries
Name Woo Kyun Bae 
Title Associate Professor 
Telephone +82-61-379-7623 
Affiliation Chonnam National University Hospital Hwasun Hospital 
Address 322 Seoyang-ro Hwasun-eup. Hwasun-gun Jeonnam, Korea 58128 
Contact Person for Updating Information
Name Woo Kyun Bae 
Title Associate Professor 
Telephone +82-61-379-7623 
Affiliation Chonnam National University Hospital Hwasun Hospital 
Address 322 Seoyang-ro Hwasun-eup. Hwasun-gun Jeonnam, Korea 58128 

4. Status

Status Information
Study Site Multi-center (Number of center : 2)
Overall Recruitment Status Active, not recruiting  
Date of First Enrollment 2016-04-07 , Actual
Target Number of Participant 92
Primary Completion Date
Study Completion Date
Recruitment Status by Participating Study Site 1
Name of Study Site Kyungpook National University Medical Center 
Recruitment Status Active, not recruiting  
Date of First Enrollment 2016-04-07 , Actual
Recruitment Status by Participating Study Site 2
Name of Study Site Yonsei University Health System, Severance Hospital 
Recruitment Status Active, not recruiting  
Date of First Enrollment 2016-04-07 , Actual

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information
Source of Monetary/Material Support 1   
Organization Name Chonnam National University Hospital Hwasun Hospital 
Organization Type Medical Institute  
Project ID  

6. Sponsor Organization

Sponsor Organization Information
Sponsor Organization 1   
Organization Name Chonnam National University Hospital Hwasun Hospital 
Organization Type Medical Institute  

7. Study Summary

Study Summary Information
Lay Summary We hypothesized that administering PCV13 on the day starting chemotherapy would be as effective as vaccinating 2 weeks prior to treatment initiation in adjuvant chemotherapy.  

8. Study Design

Study Design Information
Study Type Interventional Study 
Study Purpose Supportive Care    
Phase Phase2/Phase3 
Intervention Model Parallel  
Blinding/Masking Open 
Allocation RCT 
Intervention Type Drug  
Intervention Description Prevenar 13 (Prevenar) 1 ample, intramuscular injection,
2 weeks before chemotherapy vs. vaccinated on the day of chemotherapy  
Number of Arms
Arm 1 Arm Label vaccinated on the day of chemotherapy 
Target Number of Participant 46 
Arm Type Experimental 
Arm Description Prevenar 13 (Prevenar) 1 ample, intramuscular injection, vaccinated on the day of chemotherapy 
Arm 2 Arm Label vaccination on 2 weeks before chemotherapy 
Target Number of Participant 46 
Arm Type Active comparator 
Arm Description Prevenar 13 (Prevenar) 1 ample, intramuscular injection, vaccinated on 2 weeks before chemotherapy 

9. Subject Eligibility

Subject Eligibility Information
Condition(s) / Problem(s) * Neoplasms
 
Rare Disease No
Inclusion
Criteria
Gender Both 
Age 18 Year ~ 80 Year
Description 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 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.  
Healthy Volunteers No

10. Outcome Measure(s)

Outcome Measure(s) Information
Type of Primary Outcome /Safety/Efficacy 
Primary Outcome(s) 1 
Outcome immunogenicity of vaccination 
Timepoint vaccination day 0, post-vaccination day 28 
Secondary Outcome(s) 1 
Outcome Safety of vaccination 
Timepoint vaccination day 0, post-vaccination day 28 

11. Study Results and Publication

Study Results and Publication Information
Result Registerd No

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information
Sharing Statement No 
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