Back to resultsSafety and Immunogenicity of the 'EuPCV15' in Healthy Korean Adults
Primary Purpose
Pneumococcal Disease
Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
EuPCV15
Prevenar13
Sponsored by
About this trial
This is an interventional prevention trial for Pneumococcal Disease
Eligibility Criteria
Inclusion Criteria:
- Healthy adults aged 19 to 50 years old
- Participants willing to give written informed consent to participate in the trial
Exclusion Criteria:
- History of invasive pneumococcal infection within 5 years at screening
- Known hypersensitivity to any component of the study vaccine
- Immune deficiency or immunosuppressive disorder
- Immunized with any licensed vaccine within 4 weeks prior to screening
- Pregnant, lactating women or women of childbearing age not using a reliable method of contraception
- Participants who in the opinion of the investigator will not be able to comply with any of the protocol required procedure
Sites / Locations
- The Catholic University of Seoul St.Mary's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
EuPCV15
Prevenar13
Arm Description
Single dose of Pneumococcal Conjugate Vaccine will be administered intramuscularly at Day 0.
Single dose of Pneumococcal Conjugate Vaccine will be administered intramuscularly at Day 0.
Outcomes
Primary Outcome Measures
Incidence of Solicited AEs (Local and Systemic)
Incidence of Unsolicited AEs
Incidence of SAEs
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04830358
Brief Title
Safety and Immunogenicity of the 'EuPCV15' in Healthy Korean Adults
Official Title
A Single Center, Randomized, Single-blind, Active Comparator Phase 1 Clinical Trial to Assess the Safety and Immunogenicity of the 'EuPCV15' in Healthy Korean Adults
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
May 28, 2020 (Actual)
Primary Completion Date
August 14, 2020 (Actual)
Study Completion Date
February 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EuBiologics Co.,Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The safety and immunogenicity of EuPCV15 compared to Prevenar13 are assessed in healthy adults.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumococcal Disease
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EuPCV15
Arm Type
Experimental
Arm Description
Single dose of Pneumococcal Conjugate Vaccine will be administered intramuscularly at Day 0.
Arm Title
Prevenar13
Arm Type
Active Comparator
Arm Description
Single dose of Pneumococcal Conjugate Vaccine will be administered intramuscularly at Day 0.
Intervention Type
Biological
Intervention Name(s)
EuPCV15
Intervention Description
15-valent Pneumococcal conjugate vaccine
Intervention Type
Biological
Intervention Name(s)
Prevenar13
Intervention Description
13-valent Pneumococcal conjugate vaccine
Primary Outcome Measure Information:
Title
Incidence of Solicited AEs (Local and Systemic)
Time Frame
within 14 days after vaccination
Title
Incidence of Unsolicited AEs
Time Frame
within 28 days after vaccination
Title
Incidence of SAEs
Time Frame
within 180 days after vaccination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy adults aged 19 to 50 years old
Participants willing to give written informed consent to participate in the trial
Exclusion Criteria:
History of invasive pneumococcal infection within 5 years at screening
Known hypersensitivity to any component of the study vaccine
Immune deficiency or immunosuppressive disorder
Immunized with any licensed vaccine within 4 weeks prior to screening
Pregnant, lactating women or women of childbearing age not using a reliable method of contraception
Participants who in the opinion of the investigator will not be able to comply with any of the protocol required procedure
Facility Information:
Facility Name
The Catholic University of Seoul St.Mary's Hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Safety and Immunogenicity of the 'EuPCV15' in Healthy Korean Adults
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