Status:
COMPLETED
Lot-to-lot Consistency of an Inactivated SARS-CoV-2 Vaccine for Prevention of COVID-19 in Healthy Adults
Lead Sponsor:
Sinovac Research and Development Co., Ltd.
Conditions:
COVID-19
Eligibility:
All Genders
26-45 years
Phase:
PHASE4
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 ...
Detailed Description
This study is a double-blind, randomized phase Ⅳ clinical trial in healthy adults aged 26-45 years to evaluate the lot-to-lot consistency, immunogenicity and safety of the commercial-scale CoronaVac i...
Eligibility Criteria
Inclusion
- Healthy adults aged 26-45;
- The subjects can understand and voluntarily sign the informed consent form ;
- Proven legal identity.
Exclusion
- Travel history / residence history of communities with case reports within 14 days prior to the study;
- History of contact with a SARS-CoV-2 infection (positive in nucleic acid test) within 14 days prior to the study;
- Have contacted patients with fever or respiratory symptoms from communities with case reports within 14 days prior to the study;
- Two or more cases of fever and / or respiratory symptoms in a small contact area of volunteers, such as home, office etc. within 14 days prior to the study;
- History of SARS-CoV-2 infection or 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, spleenlessness, functional spleenlessness, spleenlessness or splenectomy resulting from any condition;
- 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;
- History of alcohol or drug abuse;
- 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;
- Already pregnant (including a positive urine pregnancy test) or are breastfeeding, planning to get pregnant within 2 months;
- The subjects participated in other clinical trials during the follow-up period, or will be planned within 3 months;
- According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.
Key Trial Info
Start Date :
May 11 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2021
Estimated Enrollment :
1080 Patients enrolled
Trial Details
Trial ID
NCT04894227
Start Date
May 11 2021
End Date
November 30 2021
Last Update
April 13 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Jingliang Wu
Huai'an, Jiangsu, China, 223300