Lot-to-lot Consistency of an Inactivated SARS-CoV-2 Vaccine Between Different Workshops in Healthy Children Aged 3-17 Years
- Conditions
- COVID-19
- Interventions
- Biological: Inactivated SARS-CoV-2 Vaccine (Vero cell) Lot 2 of the workshop 3Biological: Inactivated SARS-CoV-2 Vaccine (Vero cell) Lot 1 of the workshop 3Biological: Inactivated SARS-CoV-2 Vaccine (Vero cell) Lot 3 of the workshop 2Biological: Inactivated SARS-CoV-2 Vaccine (Vero cell) Lot 2 of the workshop 2Biological: Inactivated SARS-CoV-2 Vaccine (Vero cell) Lot 3 of the workshop 3Biological: Inactivated SARS-CoV-2 Vaccine (Vero cell) Lot 1 of the workshop 2Biological: Inactivated SARS-CoV-2 Vaccine (Vero cell) Lot 1 of the workshop 1
- Registration Number
- NCT05112913
- Lead Sponsor
- Sinovac Research and Development Co., Ltd.
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 2520
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Inactivated SARS-CoV-2 vaccine Lot 2 of the workshop 3 Inactivated SARS-CoV-2 Vaccine (Vero cell) 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 Lot 1 of the workshop 3 Inactivated SARS-CoV-2 Vaccine (Vero cell) 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 Lot 3 of the workshop 2 Inactivated SARS-CoV-2 Vaccine (Vero cell) 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 Lot 2 of the workshop 2 Inactivated SARS-CoV-2 Vaccine (Vero cell) 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 Lot 3 of the workshop 3 Inactivated SARS-CoV-2 Vaccine (Vero cell) 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 Lot 1 of the workshop 2 Inactivated SARS-CoV-2 Vaccine (Vero cell) 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 Lot 1 of the workshop 1 Inactivated SARS-CoV-2 Vaccine (Vero cell) 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.
- Primary Outcome Measures
Name Time Method Geometric mean titer(GMT) of neutralizing antibody to live SARS-CoV-2 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 Outcome Measures
Name Time Method Incidence of adverse reactions 0-28 days after vaccination 0-28 days after vaccination The incidence of adverse reactions of each lot of COVID-19 vaccine 0-28 days after vaccination
Geometric mean increase (GMI) of the neutralizing antibody to live SARS-CoV-2 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 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 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 0-7 days after vaccination The incidence of adverse reactions of each lot of COVID-19 vaccine 0-7 days after vaccination
Trial Locations
- Locations (1)
Yaliang county Center for Disease Control and Prevention
🇨🇳Xi'an, Shanxi, China