Safety and Immunogenicity of the 'EuPCV15' in Healthy Korean Adults
Phase 1
Completed
- Conditions
- Pneumococcal Disease
- Registration Number
- NCT04830358
- Lead Sponsor
- EuBiologics Co.,Ltd
- Brief Summary
The safety and immunogenicity of EuPCV15 compared to Prevenar13 are assessed in healthy adults.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Incidence of Unsolicited AEs within 28 days after vaccination Incidence of Solicited AEs (Local and Systemic) within 14 days after vaccination Incidence of SAEs within 180 days after vaccination
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
The Catholic University of Seoul St.Mary's Hospital
🇰🇷Seoul, Korea, Republic of
The Catholic University of Seoul St.Mary's Hospital🇰🇷Seoul, Korea, Republic of