Safety and Immunogenicity Study of Inactivated Vaccine for Prevention of COVID-19

NCT ID: NCT04551547

Last Updated: 2023-10-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 552 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-31
• Study Completion Date: 2023-02-08

Brief Summary

This study is a randomized, double-blinded, and placebo controlled phase 1&2 clinical trial of the SARS-CoV-2 inactivated vaccine manufactured by Sinovac Research & Development Co., Ltd. The purpose of this study is to evaluate the safety and immunogenicity of the experimental vaccine in healthy children and adolescents aged 3-17 years

Detailed Description

This study is a randomized, double-blinded, single-center, placebo-controlled phase 1&2 clinical trial in children and adolescents aged 3-17 years. The experimental vaccine and placebo were both manufactured by Sinovac Research & Development Co., Ltd. A total of 552 subjects will be enrolled, with 72 at phase 1, and 480 at phase 2. Subjects will be assigned to receive two doses of different dosage of experimental vaccine or placebo on the schedule of day 0,28. Subjects in Phase receive the second dose 10 months or 12 months after the second dose.

Conditions

COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Experimental Vaccine-low dosage

low dosage inactivated SARS-CoV-2 vaccine

Group Type: EXPERIMENTAL

Two doses of low dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28

Intervention Type: BIOLOGICAL

The inactivated SARS-CoV-2 vaccine was manufactured by Sinovac Research \& Development Co., Ltd., with a antigen content of 300SU/0.5ml

Experimental Vaccine-medium dosage

medium dosage inactivated SARS-CoV-2 vaccine

Group Type: EXPERIMENTAL

Two doses of medium dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28

Intervention Type: BIOLOGICAL

The inactivated SARS-CoV-2 vaccine was manufactured by Sinovac Research \& Development Co., Ltd., with a antigen content of 600SU/0.5ml

Placebo

No active ingredient in the placebo

Group Type: PLACEBO_COMPARATOR

Two doses of placebo at the schedule of day 0,28

Intervention Type: OTHER

The placebo contains no active ingredient and manufactured by Sinovac Research \& Development Co., Ltd.

Interventions

Two doses of low dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28

The inactivated SARS-CoV-2 vaccine was manufactured by Sinovac Research \& Development Co., Ltd., with a antigen content of 300SU/0.5ml

Intervention Type: BIOLOGICAL

Two doses of medium dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28

The inactivated SARS-CoV-2 vaccine was manufactured by Sinovac Research \& Development Co., Ltd., with a antigen content of 600SU/0.5ml

Intervention Type: BIOLOGICAL

Two doses of placebo at the schedule of day 0,28

The placebo contains no active ingredient and manufactured by Sinovac Research \& Development Co., Ltd.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Healthy children and adolescents aged 3-17 years;
• The subject and/or guardian can understand and voluntarily sign the informed consent form (double sign required for 8-17 years old);
• Proven legal identity.

Exclusion Criteria

• Travel history / residence history of communities with case reports within 14 days;
• History of contact with a SARS-CoV-2 infection (positive in nucleic acid test) within 14 days;
• Have contacted patients with fever or respiratory symptoms from communities with case reports within 14 days;
• Two or more cases of fever and / or respiratory symptoms in a small contact area of volunteers, such as home, office etc. within 14 days;
• History of SARS-CoV-2 infection;
• History of asthma, history of allergy to the vaccine or vaccine components, or serious adverse reactions to the vaccine, such as urticaria, dyspnea, and angioedema;
• Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.;
• Autoimmune disease or immunodeficiency / immunosuppression;
• Severe chronic diseases, severe cardiovascular diseases, hypertension and diabetes that cannot be controlled by drugs, liver or kidney diseases, malignant tumors, etc.;
• Severe neurological disease (epilepsy, convulsions or convulsions) or mental illness;
• Thyroid disease or history of thyroidectomy, spleenlessness, functional spleenlessness, spleenlessness or splenectomy resulting from any condition;
• Diagnosed abnormal blood coagulation function (eg, lack of blood coagulation factors, blood coagulopathy, abnormal platelets) or obvious bruising or blood coagulation;
• Immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids (excluding allergic rhinitis corticosteroid spray therapy, acute noncomplicated dermatitis superficial corticosteroid therapy) in the past 6 months;
• Physical examination has clinically significant abnormal hematology and biochemistry laboratory test results that exceed the reference value range (only applicable to phase I clinical trials):

1. Blood routine test: white blood cell count, hemoglobin, platelet count;

2. Detection of blood biochemical indicators: alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin (TBIL), creatinine (CR), fasting blood glucose;

3. Urine routine index: urine protein (PRO);

• History of alcohol or drug abuse;
• Receipt of blood products within in the past 3 months;
• Receipt of other investigational drugs in the past 30 days;
• Receipt of attenuated live vaccines in the past 14 days;
• Receipt of inactivated or subunit vaccines in the past 7 days;
• Acute diseases or acute exacerbation of chronic diseases in the past 7 days;
• Axillary temperature >37.0°C;
• Already pregnant (including a positive urine pregnancy test) or are breastfeeding, planning to get pregnant within 3 months;
• According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sinovac Research and Development Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yuliang Zhao, Master

Role: PRINCIPAL_INVESTIGATOR

Hubei Provincial Center for Disease Control and Prevention

Locations

Zanhuang county Center for Disease Control and Prevention

Shijiazhuang, Hebei, China

Countries

China

References

Han B, Song Y, Li C, Yang W, Ma Q, Jiang Z, Li M, Lian X, Jiao W, Wang L, Shu Q, Wu Z, Zhao Y, Li Q, Gao Q. Safety, tolerability, and immunogenicity of an inactivated SARS-CoV-2 vaccine (CoronaVac) in healthy children and adolescents: a double-blind, randomised, controlled, phase 1/2 clinical trial. Lancet Infect Dis. 2021 Dec;21(12):1645-1653. doi: 10.1016/S1473-3099(21)00319-4. Epub 2021 Jun 28.

Reference Type: DERIVED

PMID: 34197764 (View on PubMed)

Other Identifiers

PRO-nCOV-1003

Identifier Type: -

Identifier Source: org_study_id