Skip to main content
OpenTrials
Completed

NCT Number: NCT05603052

A Phase III of COVID-19 Vaccine EuCorVac-19 in Healthy Adults Aged 18 Years and Older

A phase III, randomized, observer-blind, active-controlled, parallel-group, multi-center study to evaluate immunogenicity and safety of a preventive COVID-19 vaccine EuCorVac-19 in healthy adults aged 18 years and older

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Trial site

Kinshasa, Democratic Republic of the Congo

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Individuals aged 18 years and older who voluntarily decide to participate in this study and provide written informed consent
  • Female of childbearing potential who agree to use medically allowed methods of contraception during the study period
  • Individuals who agrees not to perform blood donation and transfusion during the study period

Exclusion criteria

  • Individual being considered to be confirmed COVID-19
  • Direct contact with COVID-19 infected person within 14 days prior to the 1st dose of the IP
  • Individuals at high risk of exposure to SARS-CoV-2
  • Individuals with clinically significant abnormalities in clinical laboratory tests, ECGs, and chest X-ray during screening
  • Individuals with fever within 72 hours prior to the 1st dose of the IP or suspected other infectious disease or symptoms associated with other infectious disease
  • Individuals with serious medical or psychiatric disease
  • History of SARS-CoV or MERS-CoV infection
  • History of allergic reaction or hypersensitivity reactions to any of components of the IP
  • History of serious adverse events, serious allergic reaction or serious hypersensitivity reactions to vaccination
  • History of receiving organ or bone marrow transplant
  • Suspected or history of drug abuse or alcohol abuse within 6 months prior to vaccination
  • History of vaccination against SARS-CoV, MERS-CoV, or SARS-CoV-2
  • History of vaccination with test vaccine substance
  • Treatment with immunosuppressants or immune modifying drugs
  • History of treatment with antipsychotics or opioid dependence
  • Pregnant or lactating women
  • Other reasons based on which the individual is considered to be ineligible for this study in the opinion of the investigator

Treatment and study plan

EuCorVac-19

Biological

COVID-19 vaccine

ChAdOx1 nCoV-19

Biological

COVID-19 vaccine

Other names: COVISHIELD

Primary outcomes

  1. The proportion of GMT of neutralizing antibody of EuCorVac-19 and ChAdOx1

    Time frame: 14 days after the 2nd vaccination

  2. The difference in neutralizing antibody SRR of EuCorVac-19 and ChAdOx1

    Time frame: 14 days after the 2nd vaccination

Secondary outcomes

  1. Occurrence of solicited Adverse Events (AEs)

    Time frame: Through 7 days after each vaccination

  2. Occurrence of unsolicited Adverse Events (AEs)

    Time frame: Through 28 days after the 2nd vaccination

Sponsors and collaborators

Lead sponsor

EuBiologics Co.,Ltd

Industry

Registry information

Official study title

A Phase III, Randomized, Observer-blind, Active-controlled, Parallel-group, Multi-center Study to Evaluate Immunogenicity and Safety of a Preventive COVID-19 Vaccine EuCorVac-19 in Healthy Adults Aged 18 Years and Older

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Nov 2, 2022
Registry last updated
Jan 7, 2025

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.

Published trials that share one or more normalized conditions with this study.