Lot-to-lot Consistency of an Inactivated SARS-CoV-2 Vaccine Between Different Workshops in Healthy Children Aged 3-17 Years

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05112913
• Other study ID #: PRO-nCOV-MA4006-SN
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: July 27, 2021
• Est. completion date: December 25, 2023

Study information

• Verified date: November 2023
• Source: Sinovac Biotech Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2520
• Est. completion date: December 25, 2023
• Est. primary completion date: November 19, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Intervention

Biological:
• Inactivated SARS-CoV-2 Vaccine (Vero cell) Lot 1 of the workshop 2
600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection
• Inactivated SARS-CoV-2 Vaccine (Vero cell) Lot 2 of the workshop 2
600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection
• Inactivated SARS-CoV-2 Vaccine (Vero cell) Lot 3 of the workshop 2
600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection
• Inactivated SARS-CoV-2 Vaccine (Vero cell) Lot 1 of the workshop 3
600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection
• Inactivated SARS-CoV-2 Vaccine (Vero cell) Lot 2 of the workshop 3
600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection
• Inactivated SARS-CoV-2 Vaccine (Vero cell) Lot 3 of the workshop 3
600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection
• Inactivated SARS-CoV-2 Vaccine (Vero cell) Lot 1 of the workshop 1
600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection

Locations

Country	Name	City	State
China	Yaliang county Center for Disease Control and Prevention	Xi'an	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
Sinovac Research and Development Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Geometric mean titer(GMT) of neutralizing antibody to live SARS-CoV-2	Geometric mean titer(GMT) of neutralizing antibody to live SARS-CoV-2 28 days after the full immunization of each lot of COVID-19 vaccine	28 days after the full immunization
Secondary	Geometric mean increase (GMI) of the neutralizing antibody to live SARS-CoV-2	Geometric mean increase (GMI) of the neutralizing antibody to live SARS-CoV-2 28 days after the full immunization of each lot of COVID-19 vaccine	28 days after the full immunization
Secondary	Seroconversion rate of the neutralizing antibody to live SARS-CoV-2	Seroconversion rate of the neutralizing antibody to live SARS-CoV-2 28 days after the full immunization of each lot of COVID-19 vaccine	28 days after the full immunization
Secondary	Seropositivity rate of the neutralizing antibody to live SARS-CoV-2	Seropositivity rate of the neutralizing antibody to live SARS-CoV-2 28 days after the full immunization of each lot of COVID-19 vaccine	28 days after the full immunization
Secondary	Incidence of adverse reactions 0-7 days after vaccination	The incidence of adverse reactions of each lot of COVID-19 vaccine 0-7 days after vaccination	0-7 days after vaccination
Secondary	Incidence of adverse reactions 0-28 days after vaccination	The incidence of adverse reactions of each lot of COVID-19 vaccine 0-28 days after vaccination	0-28 days after vaccination