Clinical trial NCT04551547: Safety and Immunogenicity Study of Inactivated Vaccine for Prevention of COVID-19
Official title: A Randomized, Double-Blinded, Placebo-Controlled, Phase Ⅰ/Ⅱ Clinical Trial, to Evaluate the Safety and Immunogenicity of the SARS-CoV-2 Inactivated Vaccine (Vero Cell) in Healthy Population Aged 3-17 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: COVID-19
Lead sponsor: Sinovac Biotech Co., Ltd
Sponsor class: INDUSTRY
First posted: 2020-09-16
Enrollment: 552
Sex: ALL
Minimum age (years): 3
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Safety index-incidence of adverse reactions
timeFrame: Day 0-28 after each dose vaccination
measure: Immunogenicity index-seroconversion rates of neutralizing antibody
timeFrame: The 28th day after the second dose vaccination
Secondary outcomes:
measure: Safety index-incidence of serious adverse events
timeFrame: From the beginning of the vaccination to 12 months after the second dose vaccination
measure: Immunogenicity index-seropositive rates of neutralizing antibody
timeFrame: The 28th day after each dose vaccination and the 12 month after the second dose vaccination
measure: Immunogenicity index-geometric mean titer (GMT) of neutralizing antibody
timeFrame: The 28th day after each dose vaccination and the 12 month after the second dose vaccination
measure: Immunogenicity index-geometric mean ratio (GMR) of neutralizing antibody
timeFrame: The 28th day after each dose vaccination and the 12 month after the second dose vaccination
measure: Safety index-Incidence rate of adverse reactions
timeFrame: Within 7 days after each dose vaccination
measure: Safety index-Incidence of abnormal laboratory index
timeFrame: On the 3th day after each dose of vaccination in phase Ⅰ
measure: Safety index-Incidence rate of AESIs
timeFrame: From the beginning of the vaccination to 12 months after the last dose vaccination
measure: Immunogenicity index- GMI of neutralizing antibody
timeFrame: 28 days after the second dose vaccination
measure: Immunogenicity index-the seroconversion rate
timeFrame: 28 days after the first dose vaccination in phase Ⅰ
measure: Immunogenicity index-the seropositive rate
timeFrame: 28 days after the first dose vaccination in phase Ⅰ
measure: Immunogenicity index-the GMT
timeFrame: 28 days after the first dose vaccination in phase Ⅰ
measure: Immunogenicity index-the GMI
timeFrame: 28 days after the first dose vaccination in phase Ⅰ
Other outcomes:
measure: Phase Ⅰ: The seropositive rate of neutralizing antibody
timeFrame: 6 months and 12 months after the second dose vaccination
measure: Phase Ⅰ:The GMT of neutralizing antibody
timeFrame: 6 months and 12 months after the second dose vaccination.
measure: Phase Ⅱ: The seropositive rate of neutralizing antibody
timeFrame: 3 months, 6 months, 9 months and 12 months after the second dose vaccination
measure: Phase Ⅱ: The GMT of neutralizing antibody
timeFrame: 3 months, 6 months, 9 months and 12 months after the second dose vaccination.
measure: Phase Ⅱ: The seropositive rate
timeFrame: 28 days after the booster dose
measure: Phase Ⅱ: The GMT
timeFrame: 28 days after the booster dose
measure: Phase Ⅱ: The GMI
timeFrame: 28 days after the booster dose
measure: Phase Ⅱ: the seropositive rate
timeFrame: 6 months and 12 months after the booster dose
measure: Phase Ⅱ: the GMT
timeFrame: 6 months and 12 months after the booster dose
Locations:
city: Shijiazhuang
country: China
facility: Zanhuang county Center for Disease Control and Prevention
state: Hebei
Study officials:
affiliation: Hubei Provincial Center for Disease Control and Prevention
name: Yuliang Zhao, Master
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.