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

NCT05003479 | Unknown Phase 1

• 1 other identifier: 2020L001-2A
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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

COVID-19

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse reactions/events

  0-28 days after each vaccination

Secondary Outcomes (8)

• Incidence of Serious Adverse Events (SAE)

  within 12 months post full vaccination

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

  Day 3 after each dose of vaccination

• Geometric mean titer of SARS-CoV-2 neutralizing antibody

  28 days, 3 months, 6 months and 12 months post full vaccination

• Geometric mean titer of SARS-CoV-2 IgG binding antibody

  28 days, 3 months, 6 months and 12 months post full vaccination

• Seroconversion rate of SARS-CoV-2 neutralizing antibody

  28 days post full vaccination

Study Arms (2)

candidate vaccine

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

Biological: Placebo

Interventions

SARS-CoV-2 Vaccine (Vero Cells), Inactivated BIOLOGICAL

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.

candidate vaccine

Placebo BIOLOGICAL

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

Placebo

Eligibility Criteria

• Age: 3 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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℃

You may not qualify if:

• 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;

Sponsors & Collaborators

• Shenzhen Kangtai Biological Products Co., LTD: lead
• Beijing Minhai Biotechnology Co., Ltd: collaborator
• Hunan Provincial Center for Disease Control and Prevention: collaborator

Study Sites (1)

Hunan Provincial Center for Diseases Control and Prevention

Changsha, Hunan, 410005, China

Location

Related Publications (1)

• Liu J, Huang B, Li G, Huang T, Wang D, Zhang L, Deng Y, Chang X, Liu Y, Li W, Zhang S, Huang W, Tan W, Gao L. Immunogenicity and Safety of a SARS-CoV-2 Inactivated Vaccine KCONVAC in Chinese Children: Randomized, Double-blind, Placebo-controlled Phase 1 and 2 Trials. Pediatr Infect Dis J. 2023 Dec 1;42(12):1136-1142. doi: 10.1097/INF.0000000000004085. Epub 2023 Sep 4.

  PMID: 37967148 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

COVID-19 Vaccines

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Central Study Contacts

Guifan Li, M.S

CONTACT

+861059613591; liguifan@biominhai.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2021
• First Posted: August 12, 2021
• Study Start: August 1, 2021
• Primary Completion: September 1, 2022
• Study Completion: October 1, 2022
• Last Updated: August 18, 2021

Record last verified: 2021-08

Locations

CN (1)