Lot-to-lot Consistency of an Inactivated SARS-CoV-2 Vaccine Between Different Workshops in Healthy Children Aged 3-17 Years
NCT ID: NCT05112913
Last Updated: 2023-11-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE4
2520 participants
INTERVENTIONAL
2021-07-27
2023-12-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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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.
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 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.
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 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.
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 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.
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 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.
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 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.
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 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.
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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
3 Years
17 Years
ALL
Yes
Sponsors
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Sinovac Research and Development Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Weijun Hu, Master
Role: PRINCIPAL_INVESTIGATOR
Shanxi Provincial Center for Disease Prevention and Control
Locations
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Yaliang county Center for Disease Control and Prevention
Xi’an, Shanxi, China
Countries
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Other Identifiers
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PRO-nCOV-MA4006-SN
Identifier Type: -
Identifier Source: org_study_id
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