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

Phase 1CompletedNCT04830358

EuBiologics Co.,Ltd60 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Pneumococcal Disease

Interventions

EuPCV15BIOLOGICAL

15-valent Pneumococcal conjugate vaccine

Prevenar13BIOLOGICAL

13-valent Pneumococcal conjugate vaccine

Eligibility

Sex: ALLMin age: 19 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

The Catholic University of Seoul St.Mary's Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Incidence of Solicited AEs (Local and Systemic)

Time frame: within 14 days after vaccination

Incidence of Unsolicited AEs

Time frame: within 28 days after vaccination

Incidence of SAEs

Time frame: within 180 days after vaccination

Data from ClinicalTrials.gov

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