Safety and Immunogenicity of the ‘EuPCV15’ in Healthy Korean Adults

Overview

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

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Single (Participant)
  • Study Primary Completion Date: August 14, 2020

Interventions

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

Arms, Groups and Cohorts

  • Experimental: EuPCV15
    • Single dose of Pneumococcal Conjugate Vaccine will be administered intramuscularly at Day 0.
  • Active Comparator: Prevenar13
    • Single dose of Pneumococcal Conjugate Vaccine will be administered intramuscularly at Day 0.

Clinical Trial Outcome Measures

Primary Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 19 Years

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • EuBiologics Co.,Ltd
  • Provider of Information About this Clinical Study
    • Sponsor

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.