NCT05603052

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,852

participants targeted

Target at P75+ for phase_3 covid19

Timeline
Completed

Started Jul 2022

Typical duration for phase_3 covid19

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 11, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 1, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 2, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2024

Completed
Last Updated

January 7, 2025

Status Verified

January 1, 2025

Enrollment Period

1.5 years

First QC Date

November 1, 2022

Last Update Submit

January 5, 2025

Conditions

COVID-19

Outcome Measures

Primary Outcomes (2)

  • The proportion of GMT of neutralizing antibody of EuCorVac-19 and ChAdOx1

    14 days after the 2nd vaccination

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

    14 days after the 2nd vaccination

Secondary Outcomes (2)

  • Occurrence of solicited Adverse Events (AEs)

    Through 7 days after each vaccination

  • Occurrence of unsolicited Adverse Events (AEs)

    Through 28 days after the 2nd vaccination

Study Arms (4)

Test group(EuCorVac-19) - Cohort A

EXPERIMENTAL

Cohort A - Immunogenicity cohort

Biological: EuCorVac-19

Comparator group(ChAdOx1) - Cohort A

ACTIVE COMPARATOR

Cohort A - Immunogenicity cohort

Biological: ChAdOx1 nCoV-19

Test group(EuCorVac-19) - Cohort B

EXPERIMENTAL

Cohort B - Safety cohort

Biological: EuCorVac-19

Comparator group(ChAdOx1) - Cohort B

ACTIVE COMPARATOR

Cohort B - Safety cohort

Biological: ChAdOx1 nCoV-19

Interventions

EuCorVac-19BIOLOGICAL

COVID-19 vaccine

Test group(EuCorVac-19) - Cohort ATest group(EuCorVac-19) - Cohort B
ChAdOx1 nCoV-19BIOLOGICAL

COVID-19 vaccine

Also known as: COVISHIELD
Comparator group(ChAdOx1) - Cohort AComparator group(ChAdOx1) - Cohort B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Trial site

Kinshasa, Democratic Republic of the Congo

Location

MeSH Terms

Conditions

COVID-19

Interventions

ChAdOx1 nCoV-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Vaccines, DNANucleic Acid-Based VaccinesVaccines, SyntheticVaccinesBiological ProductsComplex MixturesCOVID-19 VaccinesViral Vaccines

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 2022

First Posted

November 2, 2022

Study Start

July 11, 2022

Primary Completion

January 15, 2024

Study Completion

January 15, 2024

Last Updated

January 7, 2025

Record last verified: 2025-01

Locations

DE(1)