## Protocol Section
### Identification Module
**NCT ID:** NCT05572879

**Brief Title:** A Phase III Study of COVID-19 Vaccine EuCorVac-19 in Healthy Adults

**Official 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

#### Organization Study ID Info
**ID:** EuSNAP_COV301
#### Organization
**Class:** INDUSTRY
**Full Name:** EuBiologics Co.,Ltd
### Status Module
#### Completion Date
**Date:** 2024-05-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-12-01

**Type:** ACTUAL

**Last Update Submit Date:** 2023-11-30

**Overall Status:** ACTIVE_NOT_RECRUITING

#### Primary Completion Date
**Date:** 2023-06-23

**Type:** ACTUAL

#### Start Date
**Date:** 2022-10-01

**Type:** ACTUAL

**Status Verified Date:** 2023-11

#### Study First Post Date
**Date:** 2022-10-10
**Type:** ACTUAL
**Study First Submit Date:** 2022-10-06
**Study First Submit QC Date:** 2022-10-06
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** EuBiologics Co.,Ltd

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief Summary:** This is a phase III, randomized, observer-blind, active-controlled, parallel group, multi-center study to compare the immunogenicity and safety of a preventive COVID-19 vaccine EuCorVac-19 to ChAdOx1 in healthy adults aged 18 years and older

### Conditions Module

**Conditions:**

- COVID-19

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** QUADRUPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 2600

**Type:** ACTUAL

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Cohort A - Immunogenicity cohort

**Intervention Names:**

- Biological: EuCorVac-19

**Label:** Test group(EuCorVac-19) - Cohort A

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Cohort A - Immunogenicity cohort

**Intervention Names:**

- Biological: ChAdOx1 nCoV-19

**Label:** Comparator group(ChAdOx1) - Cohort A

**Type:** ACTIVE_COMPARATOR

#### Arm Group 3

**Description:** Cohort B - Safety cohort

**Intervention Names:**

- Biological: EuCorVac-19

**Label:** Test group(EuCorVac-19) - Cohort B

**Type:** EXPERIMENTAL

#### Arm Group 4

**Description:** Cohort B - Safety cohort

**Intervention Names:**

- Biological: ChAdOx1 nCoV-19

**Label:** Comparator group(ChAdOx1) - Cohort B

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Test group(EuCorVac-19) - Cohort A

- Test group(EuCorVac-19) - Cohort B

**Description:** COVID-19 vaccine

**Name:** EuCorVac-19

**Type:** BIOLOGICAL

#### Intervention 2

**Arm Group Labels:**

- Comparator group(ChAdOx1) - Cohort A

- Comparator group(ChAdOx1) - Cohort B

**Description:** COVID-19 vaccine

**Name:** ChAdOx1 nCoV-19

**Other Names:**

- COVISHIELD

**Type:** BIOLOGICAL

### Outcomes Module

#### Primary Outcomes

**Measure:** The proportion of GMT of neutralizing antibody of EuCorVac-19 and ChAdOx1

**Time Frame:** 14 days after the 2nd vaccination

**Measure:** The difference in neutralizing antibody SRR of EuCorVac-19 and ChAdOx1

**Time Frame:** 14 days after the 2nd vaccination

#### Secondary Outcomes

**Measure:** Occurrence of solicited Adverse Events (AEs)

**Time Frame:** Through 7 days after each vaccination

**Measure:** Occurrence of unsolicited Adverse Events (AEs)

**Time Frame:** Through 28 days after the 2nd vaccination

### Eligibility Module

**Eligibility Criteria:** 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

**Healthy Volunteers:** True

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Manila

**Country:** Philippines

**Facility:** Trial site

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000011024

- Term: Pneumonia, Viral

- ID: D000011014

- Term: Pneumonia

- ID: D000012141

- Term: Respiratory Tract Infections

- ID: D000007239

- Term: Infections

- ID: D000014777

- Term: Virus Diseases

- ID: D000018352

- Term: Coronavirus Infections

- ID: D000003333

- Term: Coronaviridae Infections

- ID: D000030341

- Term: Nidovirales Infections

- ID: D000012327

- Term: RNA Virus Infections

- ID: D000008171

- Term: Lung Diseases

- ID: D000012140

- Term: Respiratory Tract Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M2561

- Name: COVID-19

- Relevance: HIGH

- As Found: COVID-19

- ID: M13904

- Name: Pneumonia

- Relevance: LOW

- As Found: Unknown

- ID: M13914

- Name: Pneumonia, Viral

- Relevance: LOW

- As Found: Unknown

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14978

- Name: Respiratory Tract Infections

- Relevance: LOW

- As Found: Unknown

- ID: M17522

- Name: Virus Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M20490

- Name: Coronavirus Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6555

- Name: Coronaviridae Infections

- Relevance: LOW

- As Found: Unknown

- ID: M23685

- Name: Nidovirales Infections

- Relevance: LOW

- As Found: Unknown

- ID: M15149

- Name: RNA Virus Infections

- Relevance: LOW

- As Found: Unknown

- ID: M11168

- Name: Lung Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000086382

- Term: COVID-19

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M17360

- Name: Vaccines

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
