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

NCT04551547 | Completed Phase 1 DMC

• 1 other identifier: PRO-nCOV-1003
• Study Type: interventional
• Target: 552
• Locations: 1 country
• Sites: 1

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

Conditions

COVID-19

Outcome Measures

Primary Outcomes (2)

• Safety index-incidence of adverse reactions

  Incidence of adverse reactions after each dose vaccination.

  Day 0-28 after each dose vaccination

• Immunogenicity index-seroconversion rates of neutralizing antibody

  Neutralizing antibody assay will be performed using the micro-neutralization method. Seroconversion will be defined as a change from seronegative (\<1:8) to seropositive (≥1:8), or ≥4 fold increase from baseline.

  The 28th day after the second dose vaccination

Secondary Outcomes (12)

• Safety index-incidence of serious adverse events

  From the beginning of the vaccination to 12 months after the second dose vaccination

• Immunogenicity index-seropositive rates of neutralizing antibody

  The 28th day after each dose vaccination and the 12 month after the second dose vaccination

• Immunogenicity index-geometric mean titer (GMT) of neutralizing antibody

  The 28th day after each dose vaccination and the 12 month after the second dose vaccination

• Immunogenicity index-geometric mean ratio (GMR) of neutralizing antibody

  The 28th day after each dose vaccination and the 12 month after the second dose vaccination

• Safety index-Incidence rate of adverse reactions

  Within 7 days after each dose vaccination

Other Outcomes (9)

• Phase Ⅰ: The seropositive rate of neutralizing antibody

  6 months and 12 months after the second dose vaccination

• Phase Ⅰ:The GMT of neutralizing antibody

  6 months and 12 months after the second dose vaccination.

• Phase Ⅱ: The seropositive rate of neutralizing antibody

  3 months, 6 months, 9 months and 12 months after the second dose vaccination

Study Arms (3)

Experimental Vaccine-low dosage

EXPERIMENTAL

low dosage inactivated SARS-CoV-2 vaccine

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

Experimental Vaccine-medium dosage

EXPERIMENTAL

medium dosage inactivated SARS-CoV-2 vaccine

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

Placebo

PLACEBO COMPARATOR

No active ingredient in the placebo

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

Interventions

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

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

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

Experimental Vaccine-medium dosage

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

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

Placebo

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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):
• Blood routine test: white blood cell count, hemoglobin, platelet count;

Sponsors & Collaborators

• Sinovac Research and Development Co., Ltd.: lead

Study Sites (1)

Zanhuang county Center for Disease Control and Prevention

Shijiazhuang, Hebei, 051230, China

Location

Related Publications (1)

• 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.

  PMID: 34197764 DERIVED

MeSH Terms

Conditions

COVID-19

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

Study Officials

• Yuliang Zhao, Master

  Hubei Provincial Center for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

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: September 15, 2020
• First Posted: September 16, 2020
• Study Start: October 31, 2020
• Primary Completion: April 30, 2021
• Study Completion: February 8, 2023
• Last Updated: October 2, 2023

Record last verified: 2021-06

Locations

CN (1)