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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04830358

Enrollment

Registered

2021-04-05

Start date

2020-05-28

Completion date

2021-02-01

Last updated

2021-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pneumococcal Disease

Brief summary

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

Interventions

BIOLOGICALEuPCV15

15-valent Pneumococcal conjugate vaccine

BIOLOGICALPrevenar13

13-valent Pneumococcal conjugate vaccine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

19 Years to 50 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Incidence of Solicited AEs (Local and Systemic)	within 14 days after vaccination
Incidence of Unsolicited AEs	within 28 days after vaccination
Incidence of SAEs	within 180 days after vaccination

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026