Clinical trial NCT05112913: Lot-to-lot Consistency of an Inactivated SARS-CoV-2 Vaccine Between Different Workshops in Healthy Children Aged 3-17 Years
Official title: A Double-blind, Randomized Clinical Trial to Evaluate the Lot-to-lot Consistency, Immunogenicity and Safety of an Inactivated SARS-CoV-2 Vaccine (CoronaVac）Between Different Workshops for Prevention of COVID-19 in Healthy Children Aged 3-17 Years
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: COVID-19
Lead sponsor: Sinovac Biotech Co., Ltd
Sponsor class: INDUSTRY
First posted: 2021-11-09
Enrollment: 2520
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 double-blind, randomized phase Ⅳ clinical trial of the inactivated SARS-CoV-2 vaccine (CoronaVac)manufactured by Sinovac Research \& Development Co., Ltd. The purpose of this study is to evaluate the lot-to-lot consistency ,immunogenicity and safety of COVID-19 vaccine between the commercialized scale in workshop 2 and 3 and the commercialized scale in workshop 1 in healthy children aged 3-17 years.

Detailed description: This study is a double-blind, randomized phase Ⅳ clinical trial in healthy children aged 3-17 years to evaluate the lot-to-lot consistency, immunogenicity and safety of the commercial-scale CoronaVac in healthy children aged 3-17 years .The experimental vaccine was manufactured by Sinovac Research \& Development Co.,Ltd. A total of 2520 healthy subjects aged 3 to 17 years old will be enrolled.The subjects will be randomly divided into 7 groups of 360 participants per group with an equal probability to received 7 batches of commercial-scale vaccine.All subjects received two doses of vaccine on day 0 and day 28.

Eligibility criteria: Inclusion Criteria:

* Healthy children aged 3-17;
* The subjects and/or guardians can understand and voluntarily sign the informed consent form (For subjects aged 8-17 years, both subjects and guardians need to sign the informed consent form)
* Proven legal identity.

Exclusion Criteria:

* History of SARS-CoV-2 infection;
* History of receiving COVID-19 vaccine;
* 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 (Systemic lupus erythematosus)or immunodeficiency / immunosuppression(HIV,history after organ transplantation)
* 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,absence of spleen, functional absence of spleen, absence of spleen due to any condition or splenectomy;
* 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;
* 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;
* Onset of various acute or chronic diseases within 7 days prior to the study;
* Axillary temperature \>37.0°C;
* The subjects participated in other clinical trials during the follow-up period, or will be planned within 3 months;
* Already pregnant (including a positive urine pregnancy test) or are breastfeeding, planning to get pregnant within 2 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: Geometric mean titer(GMT) of neutralizing antibody to live SARS-CoV-2
timeFrame: 28 days after the full immunization
Secondary outcomes:
measure: Geometric mean increase (GMI) of the neutralizing antibody to live SARS-CoV-2
timeFrame: 28 days after the full immunization
measure: Seroconversion rate of the neutralizing antibody to live SARS-CoV-2
timeFrame: 28 days after the full immunization
measure: Seropositivity rate of the neutralizing antibody to live SARS-CoV-2
timeFrame: 28 days after the full immunization
measure: Incidence of adverse reactions 0-7 days after vaccination
timeFrame: 0-7 days after vaccination
measure: Incidence of adverse reactions 0-28 days after vaccination
timeFrame: 0-28 days after vaccination
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Yaliang county Center for Disease Control and Prevention
state: Shanxi
Study officials:
affiliation: Shanxi Provincial Center for Disease Prevention and Control
name: Weijun Hu, Master
role: PRINCIPAL_INVESTIGATOR
References: