Lot-to-lot Consistency of an Inactivated SARS-CoV-2 Vaccine Between Different Workshops in Healthy Children Aged 3-17 Years
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
1 other identifier
interventional
2,520
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 covid19
Started Jul 2021
Longer than P75 for phase_4 covid19
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 27, 2021
CompletedFirst Submitted
Initial submission to the registry
November 8, 2021
CompletedFirst Posted
Study publicly available on registry
November 9, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 19, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 25, 2023
CompletedNovember 7, 2023
November 1, 2023
4 months
November 8, 2021
November 5, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Geometric mean increase (GMI) of the neutralizing antibody to live SARS-CoV-2
28 days after the full immunization
Seroconversion rate of the neutralizing antibody to live SARS-CoV-2
28 days after the full immunization
Seropositivity rate of the neutralizing antibody to live SARS-CoV-2
28 days after the full immunization
Incidence of adverse reactions 0-7 days after vaccination
0-7 days after vaccination
Incidence of adverse reactions 0-28 days after vaccination
0-28 days after vaccination
Study Arms (7)
Inactivated SARS-CoV-2 vaccine Lot 1 of the workshop 2
EXPERIMENTAL360 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.
Inactivated SARS-CoV-2 vaccine Lot 2 of the workshop 2
EXPERIMENTAL360 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.
Inactivated SARS-CoV-2 vaccine Lot 3 of the workshop 2
EXPERIMENTAL360 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.
Inactivated SARS-CoV-2 vaccine Lot 1 of the workshop 3
EXPERIMENTAL360 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.
Inactivated SARS-CoV-2 vaccine Lot 2 of the workshop 3
EXPERIMENTAL360 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.
Inactivated SARS-CoV-2 vaccine Lot 3 of the workshop 3
EXPERIMENTAL360 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.
Inactivated SARS-CoV-2 vaccine Lot 1 of the workshop 1
ACTIVE COMPARATOR360 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.
Interventions
600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection
600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection
600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection
600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection
600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection
600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection
600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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;
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Yaliang county Center for Disease Control and Prevention
Xi’an, Shanxi, 710054, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Weijun Hu, Master
Shanxi Provincial Center for Disease Prevention and Control
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 8, 2021
First Posted
November 9, 2021
Study Start
July 27, 2021
Primary Completion
November 19, 2021
Study Completion
December 25, 2023
Last Updated
November 7, 2023
Record last verified: 2023-11