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OpenTrials
Completed

NCT Number: NCT04830358

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

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

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Key information

Conditions

Pneumococcal Disease Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Pneumococcal Infections Streptococcal Infections

Age range

19 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The Catholic University of Seoul St.Mary's Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy adults aged 19 to 50 years old
  • Participants willing to give written informed consent to participate in the trial

Exclusion criteria

  • History of invasive pneumococcal infection within 5 years at screening
  • Known hypersensitivity to any component of the study vaccine
  • Immune deficiency or immunosuppressive disorder
  • Immunized with any licensed vaccine within 4 weeks prior to screening
  • Pregnant, lactating women or women of childbearing age not using a reliable method of contraception
  • Participants who in the opinion of the investigator will not be able to comply with any of the protocol required procedure

Treatment and study plan

EuPCV15

Biological

15-valent Pneumococcal conjugate vaccine

Prevenar13

Biological

13-valent Pneumococcal conjugate vaccine

Primary outcomes

  1. Incidence of Solicited AEs (Local and Systemic)

    Time frame: within 14 days after vaccination

  2. Incidence of Unsolicited AEs

    Time frame: within 28 days after vaccination

  3. Incidence of SAEs

    Time frame: within 180 days after vaccination

Sponsors and collaborators

Lead sponsor

EuBiologics Co.,Ltd

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Apr 5, 2021
Registry last updated
Oct 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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