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

Primary Purpose

COVID-19

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Inactivated SARS-CoV-2 Vaccine (Vero cell) Lot 1 of the workshop 2
Inactivated SARS-CoV-2 Vaccine (Vero cell) Lot 2 of the workshop 2
Inactivated SARS-CoV-2 Vaccine (Vero cell) Lot 3 of the workshop 2
Inactivated SARS-CoV-2 Vaccine (Vero cell) Lot 1 of the workshop 3
Inactivated SARS-CoV-2 Vaccine (Vero cell) Lot 2 of the workshop 3
Inactivated SARS-CoV-2 Vaccine (Vero cell) Lot 3 of the workshop 3
Inactivated SARS-CoV-2 Vaccine (Vero cell) Lot 1 of the workshop 1
Sponsored by
Sinovac Research and Development Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for COVID-19

Eligibility Criteria

3 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Yaliang county Center for Disease Control and Prevention

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Inactivated SARS-CoV-2 vaccine Lot 1 of the workshop 2

Inactivated SARS-CoV-2 vaccine Lot 2 of the workshop 2

Inactivated SARS-CoV-2 vaccine Lot 3 of the workshop 2

Inactivated SARS-CoV-2 vaccine Lot 1 of the workshop 3

Inactivated SARS-CoV-2 vaccine Lot 2 of the workshop 3

Inactivated SARS-CoV-2 vaccine Lot 3 of the workshop 3

Inactivated SARS-CoV-2 vaccine Lot 1 of the workshop 1

Arm Description

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.

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.

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.

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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
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
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

Full Information

First Posted
November 8, 2021
Last Updated
December 13, 2021
Sponsor
Sinovac Research and Development Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05112913
Brief Title
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

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 27, 2021 (Actual)
Primary Completion Date
November 17, 2021 (Actual)
Study Completion Date
June 25, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sinovac Research and Development Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
2520 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Inactivated SARS-CoV-2 vaccine Lot 1 of the workshop 2
Arm Type
Experimental
Arm Description
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.
Arm Title
Inactivated SARS-CoV-2 vaccine Lot 2 of the workshop 2
Arm Type
Experimental
Arm Description
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.
Arm Title
Inactivated SARS-CoV-2 vaccine Lot 3 of the workshop 2
Arm Type
Experimental
Arm Description
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.
Arm Title
Inactivated SARS-CoV-2 vaccine Lot 1 of the workshop 3
Arm Type
Experimental
Arm Description
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.
Arm Title
Inactivated SARS-CoV-2 vaccine Lot 2 of the workshop 3
Arm Type
Experimental
Arm Description
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.
Arm Title
Inactivated SARS-CoV-2 vaccine Lot 3 of the workshop 3
Arm Type
Experimental
Arm Description
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.
Arm Title
Inactivated SARS-CoV-2 vaccine Lot 1 of the workshop 1
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Inactivated SARS-CoV-2 Vaccine (Vero cell) Lot 1 of the workshop 2
Other Intervention Name(s)
CoronaVac
Intervention Description
600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection
Intervention Type
Biological
Intervention Name(s)
Inactivated SARS-CoV-2 Vaccine (Vero cell) Lot 2 of the workshop 2
Other Intervention Name(s)
CoronaVac
Intervention Description
600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection
Intervention Type
Biological
Intervention Name(s)
Inactivated SARS-CoV-2 Vaccine (Vero cell) Lot 3 of the workshop 2
Other Intervention Name(s)
CoronaVac
Intervention Description
600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection
Intervention Type
Biological
Intervention Name(s)
Inactivated SARS-CoV-2 Vaccine (Vero cell) Lot 1 of the workshop 3
Other Intervention Name(s)
CoronaVac
Intervention Description
600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection
Intervention Type
Biological
Intervention Name(s)
Inactivated SARS-CoV-2 Vaccine (Vero cell) Lot 2 of the workshop 3
Other Intervention Name(s)
CoronaVac
Intervention Description
600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection
Intervention Type
Biological
Intervention Name(s)
Inactivated SARS-CoV-2 Vaccine (Vero cell) Lot 3 of the workshop 3
Other Intervention Name(s)
CoronaVac
Intervention Description
600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection
Intervention Type
Biological
Intervention Name(s)
Inactivated SARS-CoV-2 Vaccine (Vero cell) Lot 1 of the workshop 1
Other Intervention Name(s)
CoronaVac
Intervention Description
600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection
Primary Outcome Measure Information:
Title
Geometric mean titer(GMT) of neutralizing antibody to live SARS-CoV-2
Description
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
Time Frame
28 days after the full immunization
Secondary Outcome Measure Information:
Title
Geometric mean increase (GMI) of the neutralizing antibody to live SARS-CoV-2
Description
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
Time Frame
28 days after the full immunization
Title
Seroconversion rate of the neutralizing antibody to live SARS-CoV-2
Description
Seroconversion rate of the neutralizing antibody to live SARS-CoV-2 28 days after the full immunization of each lot of COVID-19 vaccine
Time Frame
28 days after the full immunization
Title
Seropositivity rate of the neutralizing antibody to live SARS-CoV-2
Description
Seropositivity rate of the neutralizing antibody to live SARS-CoV-2 28 days after the full immunization of each lot of COVID-19 vaccine
Time Frame
28 days after the full immunization
Title
Incidence of adverse reactions 0-7 days after vaccination
Description
The incidence of adverse reactions of each lot of COVID-19 vaccine 0-7 days after vaccination
Time Frame
0-7 days after vaccination
Title
Incidence of adverse reactions 0-28 days after vaccination
Description
The incidence of adverse reactions of each lot of COVID-19 vaccine 0-28 days after vaccination
Time Frame
0-28 days after vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Weijun Hu, Master
Organizational Affiliation
Shanxi Provincial Center for Disease Prevention and Control
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yaliang county Center for Disease Control and Prevention
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
710054
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

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