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NCT04830358 Clinical Trial

Safety and Immunogenicity of the 'EuPCV15' in Healthy Korean Adults

Pneumococcal Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04830358
Other study ID # EuVCT_PCV101
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date May 28, 2020
Est. completion date February 1, 2021

Study information
Verified date March 2021
Source EuBiologics Co.,Ltd
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The safety and immunogenicity of EuPCV15 compared to Prevenar13 are assessed in healthy adults.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date February 1, 2021
Est. primary completion date August 14, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years to 50 Years
Eligibility Inclusion Criteria: 1. Healthy adults aged 19 to 50 years old 2. Participants willing to give written informed consent to participate in the trial Exclusion Criteria: 1. History of invasive pneumococcal infection within 5 years at screening 2. Known hypersensitivity to any component of the study vaccine 3. Immune deficiency or immunosuppressive disorder 4. Immunized with any licensed vaccine within 4 weeks prior to screening 5. Pregnant, lactating women or women of childbearing age not using a reliable method of contraception 6. Participants who in the opinion of the investigator will not be able to comply with any of the protocol required procedure

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• EuPCV15
15-valent Pneumococcal conjugate vaccine
• Prevenar13
13-valent Pneumococcal conjugate vaccine

Locations
Country Name City State
Korea, Republic of The Catholic University of Seoul St.Mary's Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
EuBiologics Co.,Ltd

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of Solicited AEs (Local and Systemic) within 14 days after vaccination
Primary Incidence of Unsolicited AEs within 28 days after vaccination
Primary Incidence of SAEs within 180 days after vaccination
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