Status:
COMPLETED
Safety and Immunogenicity of the 'EuPCV15' in Healthy Korean Adults
Lead Sponsor:
EuBiologics Co.,Ltd
Conditions:
Pneumococcal Disease
Eligibility:
All Genders
19-50 years
Phase:
PHASE1
Brief Summary
The safety and immunogenicity of EuPCV15 compared to Prevenar13 are assessed in healthy adults.
Eligibility Criteria
Inclusion
- Healthy adults aged 19 to 50 years old
- Participants willing to give written informed consent to participate in the trial
Exclusion
- 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
Key Trial Info
Start Date :
May 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2021
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04830358
Start Date
May 28 2020
End Date
February 1 2021
Last Update
October 7 2021
Active Locations (1)
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1
The Catholic University of Seoul St.Mary's Hospital
Seoul, South Korea