## Protocol Section
### Identification Module
**NCT ID:** NCT05003479

**Brief Title:** Clinical Trial of SARS-CoV-2 Vaccine (Vero Cells), Inactivated in Healthy Population Aged 3 to 17 Years(COVID-19)

**Official Title:** A Randomized, Double-blind, Placebo-controlled Phase Ⅰ Clinical Study to Evaluate the Safety and Immunogenicity of SARS-CoV-2 Vaccine (Vero Cells), Inactivated in Healthy Population Aged 3 to 17 Years

#### Organization Study ID Info
**ID:** 2020L001-2A
#### Organization
**Class:** INDUSTRY
**Full Name:** Shenzhen Kangtai Biological Products Co., LTD
### Status Module
#### Completion Date
**Date:** 2022-10

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** NOT_YET_RECRUITING
#### Last Update Post Date
**Date:** 2021-08-18

**Type:** ACTUAL

**Last Update Submit Date:** 2021-08-11

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2022-09

**Type:** ESTIMATED

#### Start Date
**Date:** 2021-08

**Type:** ESTIMATED

**Status Verified Date:** 2021-08

#### Study First Post Date
**Date:** 2021-08-12
**Type:** ACTUAL
**Study First Submit Date:** 2021-08-10
**Study First Submit QC Date:** 2021-08-10
### Sponsor Collaborators Module

#### Collaborators

**Class:** INDUSTRY

**Name:** Beijing Minhai Biotechnology Co., Ltd

**Class:** OTHER

**Name:** Hunan Provincial Center for Disease Control and Prevention

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Shenzhen Kangtai Biological Products Co., LTD

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief Summary:** This study is a randomized, double-blinded, and placebo controlled phase Ⅰ clinical trial of the SARS-CoV-2 inactivated vaccine to evaluate the safety and immunogenicity of the experimental vaccine in healthy population aged 3 to 17 years.

### Conditions Module

**Conditions:**

- COVID-19

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 84

**Type:** ESTIMATED

**Phases:**

- PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Biological: SARS-CoV-2 Vaccine (Vero Cells), Inactivated

**Label:** candidate vaccine

**Type:** EXPERIMENTAL

#### Arm Group 2

**Intervention Names:**

- Biological: Placebo

**Label:** Placebo

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- candidate vaccine

**Description:** 2 doses of SARS-CoV-2 Vaccine (Vero Cells), Inactivated should be administered as an intramuscular injection into the lateral deltoid of the upper arm with a 28-day interval.

**Name:** SARS-CoV-2 Vaccine (Vero Cells), Inactivated

**Type:** BIOLOGICAL

#### Intervention 2

**Arm Group Labels:**

- Placebo

**Description:** 2 doses of Placebo should be administered as an intramuscular injection into the lateral deltoid of the upper arm with a 28-day interval.

**Name:** Placebo

**Type:** BIOLOGICAL

### Outcomes Module

#### Primary Outcomes

**Measure:** Incidence of adverse reactions/events

**Time Frame:** 0-28 days after each vaccination

#### Secondary Outcomes

**Measure:** Incidence of Serious Adverse Events (SAE)

**Time Frame:** within 12 months post full vaccination

**Measure:** Incidence of abnormal indicators of laboratory safety examinations(including blood routine, blood biochemistry, urine routine, thyroid function and coagulation function)

**Time Frame:** Day 3 after each dose of vaccination

**Measure:** Geometric mean titer of SARS-CoV-2 neutralizing antibody

**Time Frame:** 28 days, 3 months, 6 months and 12 months post full vaccination

**Measure:** Geometric mean titer of SARS-CoV-2 IgG binding antibody

**Time Frame:** 28 days, 3 months, 6 months and 12 months post full vaccination

**Measure:** Seroconversion rate of SARS-CoV-2 neutralizing antibody

**Time Frame:** 28 days post full vaccination

**Measure:** Seroconversion rate of SARS-CoV-2 IgG binding antibody

**Time Frame:** 28 days post full vaccination

**Measure:** Seropositive rate of SARS-CoV-2 neutralizing antibody

**Time Frame:** 3 months, 6 months and 12 months post full vaccination

**Measure:** Seropositive rate of SARS-CoV-2 IgG binding antibody

**Time Frame:** 3 months, 6 months and 12 months post full vaccination

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Healthy residents aged 3 to 17 years at the time of consent
* Subjects and/or their guardian agree to sign the informed consent forms voluntarily.
* Be able to comply with study requirements/procedures.
* Axillary temperature ≤ 37.0℃

Exclusion Criteria:

* Within 14 days before vaccination, subjects have been abroad and to villages/communities experienced COVID-19 epidemics, and in contact with COVID-19 cases or suspected cases. Subjects are under isolation observation, or living in the villages/communities with COVID-19 cases or suspected cases;
* Confirmed cases, suspected cases or asymptomatic cases with COVID-19 (refer to Information System of China Disease Prevention and Control);
* Subjects with history of SARS virus infection by self-reported;
* Positive in throat swab through RT-PCR;
* History of vaccination of various COVID-19 vaccines or positive in SARS-CoV-2 antibody test;
* Positive urine pregnancy test for females with menarche
* With abnormal indicators, such as blood biochemistry, blood routine, urine routine, thyroid function and coagulation function which might show clinical meaning, before administration;
* History of severe allergic reactions (such as acute anaphylaxis, urticaria, skin eczema, dyspnea, angioneurotic edema or abdominal pain) or allergy to known composition of inactivated SARS-CoV-2 vaccine;
* History or family history of convulsion, epilepsy, encephalopathy or mental illness;
* Subjects with congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.;
* Subjects with known or suspected diseases include: severe respiratory diseases, severe cardiovascular diseases, severe liver and kidney diseases, drug-uncontrollable hypertension, diabetic complications, malignant tumors, various acute diseases or acute onset of chronic diseases;
* Diagnosed with congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia or other autoimmune diseases;
* History of coagulation dysfunction (e.g. Coagulation factor deficiency, coagulation disease);
* Subjects receiving anti-TB treatment;
* Subjects receiving other research drugs within 6 months before vaccination;
* Subjects receiving immunotherapy or inhibitor therapy within 3 months (consistently oral or infusion for more than 14 days);
* Subjects receiving blood products within 3 months before administration;
* Subjects vaccinated with live attenuated vaccine within 14 days before vaccination;
* Subjects vaccinated with other vaccine within 7 days before vaccination;
* The researchers shall judge the other conditions which might be not in compliance with the requirements of this clinical trial.

**Healthy Volunteers:** True

**Maximum Age:** 17 Years

**Minimum Age:** 3 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** liguifan@biominhai.com

**Name:** Guifan Li, M.S

**Phone:** +861059613591

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Changsha

**Contacts:**

***Contact 1:***

- **Email:** ymlc01@hncdc.com

- **Name:** Tao Huang

- **Phone:** +8673184305935

- **Role:** CONTACT

**Country:** China

**Facility:** Hunan Provincial Center for Diseases Control and Prevention

**State:** Hunan

**Zip:** 410005

## 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
