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

Overview

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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: November 19, 2021

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.

Interventions

  • 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
  • Biological: 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
  • Biological: 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
  • Biological: 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
  • Biological: 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
  • Biological: 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
  • Biological: 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

Arms, Groups and Cohorts

  • Experimental: Inactivated SARS-CoV-2 vaccine Lot 1 of the workshop 2
    • 360 Participants aged 3-17 years(including 52 children aged 3-5 years,154 children aged 6-11 years and 154 adolescents aged 12-17 years) will receive Inactivated SARS-CoV-2 vaccine Lot 1 of the workshop 2 according to 0,28-day immunization schedule.
  • Experimental: Inactivated SARS-CoV-2 vaccine Lot 2 of the workshop 2
    • 360 Participants aged 3-17 years(including 52 children aged 3-5 years,154 children aged 6-11 years and 154 adolescents aged 12-17 years) will receive Inactivated SARS-CoV-2 vaccine Lot 2 of the workshop 2 according to 0,28-day immunization schedule.
  • Experimental: Inactivated SARS-CoV-2 vaccine Lot 3 of the workshop 2
    • 360 Participants aged 3-17 years(including 52 children aged 3-5 years,154 children aged 6-11 years and 154 adolescents aged 12-17 years) will receive Inactivated SARS-CoV-2 vaccine Lot 3 of the workshop 2 according to 0,28-day immunization schedule.
  • Experimental: Inactivated SARS-CoV-2 vaccine Lot 1 of the workshop 3
    • 360 Participants aged 3-17 years(including 52 children aged 3-5 years,154 children aged 6-11 years and 154 adolescents aged 12-17 years) will receive Inactivated SARS-CoV-2 vaccine Lot 1 of the workshop 3 according to 0,28-day immunization schedule.
  • Experimental: Inactivated SARS-CoV-2 vaccine Lot 2 of the workshop 3
    • 360 Participants aged 3-17 years(including 52 children aged 3-5 years,154 children aged 6-11 years and 154 adolescents aged 12-17 years) will receive Inactivated SARS-CoV-2 vaccine Lot 2 of the workshop 3 according to 0,28-day immunization schedule.
  • Experimental: Inactivated SARS-CoV-2 vaccine Lot 3 of the workshop 3
    • 360 Participants aged 3-17 years(including 52 children aged 3-5 years,154 children aged 6-11 years and 154 adolescents aged 12-17 years) will receive Inactivated SARS-CoV-2 vaccine Lot 3 of the workshop 3 according to 0,28-day immunization schedule.
  • Active Comparator: Inactivated SARS-CoV-2 vaccine Lot 1 of the workshop 1
    • 360 Participants aged 3-17 years(including 52 children aged 3-5 years,154 children aged 6-11 years and 154 adolescents aged 12-17 years) will receive Inactivated SARS-CoV-2 vaccine Lot 1 of the workshop 1 according to 0,28-day immunization schedule.

Clinical Trial Outcome Measures

Primary Measures

  • Geometric mean titer(GMT) of neutralizing antibody to live SARS-CoV-2
    • Time Frame: 28 days after the full immunization
    • 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

Secondary Measures

  • Geometric mean increase (GMI) of the neutralizing antibody to live SARS-CoV-2
    • Time Frame: 28 days after the full immunization
    • 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
  • Seroconversion rate of the neutralizing antibody to live SARS-CoV-2
    • Time Frame: 28 days after the full immunization
    • Seroconversion rate of the neutralizing antibody to live SARS-CoV-2 28 days after the full immunization of each lot of COVID-19 vaccine
  • Seropositivity rate of the neutralizing antibody to live SARS-CoV-2
    • Time Frame: 28 days after the full immunization
    • Seropositivity rate of the neutralizing antibody to live SARS-CoV-2 28 days after the full immunization of each lot of COVID-19 vaccine
  • Incidence of adverse reactions 0-7 days after vaccination
    • Time Frame: 0-7 days after vaccination
    • The incidence of adverse reactions of each lot of COVID-19 vaccine 0-7 days after vaccination
  • Incidence of adverse reactions 0-28 days after vaccination
    • Time Frame: 0-28 days after vaccination
    • The incidence of adverse reactions of each lot of COVID-19 vaccine 0-28 days after vaccination

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 3 Years

Maximum Age: 17 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Sinovac Research and Development Co., Ltd.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Weijun Hu, Master, Principal Investigator, Shanxi Provincial Center for Disease Prevention and Control

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