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

October 6, 2021 updated by: EuBiologics Co.,Ltd

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • The Catholic University of Seoul St.Mary's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EuPCV15
Single dose of Pneumococcal Conjugate Vaccine will be administered intramuscularly at Day 0.
Biological: EuPCV15
15-valent Pneumococcal conjugate vaccine
Active Comparator: Prevenar13
Single dose of Pneumococcal Conjugate Vaccine will be administered intramuscularly at Day 0.
Biological: Prevenar13
13-valent Pneumococcal conjugate vaccine

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

EuBiologics Co.,Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 28, 2020

Primary Completion (Actual)

August 14, 2020

Study Completion (Actual)

February 1, 2021

Study Registration Dates

First Submitted

March 31, 2021

First Submitted That Met QC Criteria

April 1, 2021

First Posted (Actual)

April 5, 2021

Study Record Updates

Last Update Posted (Actual)

October 7, 2021

Last Update Submitted That Met QC Criteria

October 6, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EuVCT_PCV101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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