Back to resultsSafety and Immunogenicity Study of Inactivated Vaccine for Prophylaxis of SARS CoV-2 Infection (COVID-19)
Primary Purpose
COVID-19
Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Two doses of medium dosage inactivated SARS-CoV-2 vaccine at the emergency vaccination schedule
Two doses of high dosage inactivated SARS-CoV-2 vaccine at the emergency vaccination schedule
Two doses of placebo at the emergency vaccination schedule
Two doses of medium dosage inactivated SARS-CoV-2 vaccine at the routine vaccination schedule
Two doses of high dosage inactivated SARS-CoV-2 vaccine at the routine vaccination schedule
Two doses of placebo at the routine vaccination schedule
Three doses of medium dosage inactivated SARS-CoV-2 vaccine at the emergency vaccination schedule
Three doses of high dosage inactivated SARS-CoV-2 vaccine at the emergency vaccination schedule
Three doses of placebo at the emergency vaccination schedule
Three doses of medium dosage inactivated SARS-CoV-2 vaccine at the routine vaccination schedule
Three doses of high dosage inactivated SARS-CoV-2 vaccine at the routine vaccination schedule
Three doses of placebo at the routine vaccination schedule
Sponsored by
About this trial
This is an interventional prevention trial for COVID-19
Eligibility Criteria
Inclusion Criteria:
- Healthy adults aged 18-59 years;
- Proven legal identity;
- Participants should be capable of understanding the informed consent form, and such form should be signed prior to enrolment ;
Exclusion Criteria:
- Travel history / residence history of Wuhan city and surrounding areas, or other communities with case reports within 14 days;
- History of contact with a SARS-CoV-2 infection (positive in nucleic acid test) within 14 days;
- Have contacted patients with fever or respiratory symptoms from Wuhan and surrounding areas, or from communities with case reports within 14 days;
- Have contacted patients with fever or respiratory symptoms from Wuhan and surrounding areas, or from communities with case reports within 14 days;
- Self-reported history of SARS;
- Self-reported history of new coronavirus infection;
- Positive in serum antibodies (IgG or IgM) screening of COVID-19;
- Positive in nasopharyngeal swabs or anal swabs through RT-PCR;
- Women who are breastfeeding, pregnant or planning to become pregnant during the study period;
- BMI≥35 kg/m2;
- 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 or immunodeficiency / immunosuppression;
- Suffering from severe chronic diseases, severe cardiovascular diseases, hypertension and diabetes that cannot be controlled by drugs, liver and 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 non-complicated dermatitis superficial corticosteroid therapy) in the past 6 months;
- Abnormal laboratory test results in the physical examination such as clinically significant abnormal hematology and biochemistry beyond the reference value range (only applicable to Phase I clinical trials);
- 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;
- Attacks of acute diseases or chronic diseases in the past 7 days;
- Axillary temperature >37.0°C;
- According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.
Sites / Locations
- Suining 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 8
Arm 9
Arm 10
Arm 11
Arm 12
Arm Type
Experimental
Experimental
Placebo Comparator
Experimental
Experimental
Placebo Comparator
Experimental
Experimental
Placebo Comparator
Experimental
Experimental
Placebo Comparator
Arm Label
Emergency schedule & Two doses of medium dosage vaccine
Emergency schedule & Two doses of high dosage vaccine
Emergency schedule &Two doses of placebo
Routine schedule & Two doses of medium dosage vaccine
Routine schedule &Two doses of high dosage vaccine
Routine schedule & Two doses of placebo
Emergency schedule & Three doses of medium dosage vaccine
Emergency schedule & Three doses of high dosage vaccine
Emergency schedule &Three doses of placebo
Routine schedule & Three doses of medium dosage vaccine
Routine schedule &Three doses of high dosage vaccine
Routine schedule &Three doses of placebo
Arm Description
24 participants in phase Ⅰand 60 participants in phase Ⅱ will receive two doses of medium dosage inactivated SARS-CoV-2 vaccine at the emergency vaccination schedule,and 60 participants in phase Ⅱ will receive one dose of booster immunization with medium dosage vaccine 6 months after the emergency schedule
24 participants in phase Ⅰand 60 participants in phase Ⅱ will receive two doses of high dosage inactivated SARS-CoV-2 vaccine at the emergency vaccination schedule,and 60 participants in phase Ⅱ will receive one dose of booster immunization with high dosage vaccine 6 months after the emergency schedule
24 participants in phase Ⅰand 30 participants in phase Ⅱ will receive two doses of placebo at the emergency vaccination schedule,and 30 participants in phase Ⅱ will receive one dose of booster immunization with placebo 6 months after the emergency schedule
24 participants in phase Ⅰand 60 participants in phase Ⅱ will receive two doses of medium dosage inactivated SARS-CoV-2 vaccine at the routine vaccination schedule,and 60 participants in phase Ⅱ will receive one dose of booster immunization with medium dosage vaccine 6 months after the routine schedule
24 participants in phase Ⅰand 60 participants in phase Ⅱ will receive two doses of high dosage inactivated SARS-CoV-2 vaccine at the routine vaccination schedule,and 60 participants in phase Ⅱ will receive one dose of booster immunization with high dosage vaccine 6 months after the routine schedule
24 participants in phase Ⅰand 30 participants in phase Ⅱ will receive two doses of placebo at the routine vaccination schedule,and 30 participants in phase Ⅱ will receive one dose of booster immunization with placebo 6 months after the routine schedule
60 participants in phase Ⅱ will receive three doses of medium dosage inactivated SARS-CoV-2 vaccine at the emergency vaccination schedule
60 participants in phase Ⅱ will receive three doses of high dosage inactivated SARS-CoV-2 vaccine at the emergency vaccination schedule
30 participants in phase Ⅱ will receive three doses of placebo at the emergency vaccination schedule
60 participants in phase Ⅱ will receive three doses of medium dosage inactivated SARS-CoV-2 vaccine at the routine vaccination schedule
60 participants in phase Ⅱ will receive three doses of high dosage inactivated SARS-CoV-2 vaccine at the routine vaccination schedule
30 participants in phase Ⅱ will receive three doses of placebo at the routine vaccination schedule
Outcomes
Primary Outcome Measures
Safety indexes of adverse reactions
Incidence of adverse reactions occured from Day 0 to Day 28 after each dose
Immunogenicity indexes of neutralizing-antibody seroconversion rates
The seroconversion rate of neutralizing antibodies 14 days (emergency schedule)/28 days (routine schedule) after the two-dose vaccination.
Secondary Outcome Measures
Safety indexes of adverse reactions
Incidence of adverse reactions 7 days after each dose of vaccination
Safety indexes of Incidence of abnormal laboratory index
Incidence of abnormal laboratory index (blood routine test, blood chemistry test,and urine routine test) on the 3th day after each dose of vaccination in phase Ⅰ
Safety indexes of serious adverse events (SAEs）
Incidence of SAEs from the beginning of the vaccination to 6 months post the whole-schedule vaccination
Immunogenicity indexes of the seropositive rate, GMT, and GMI of neutralizing antibodies
The seropositive rate, GMT, and GMI of neutralizing antibodies 14 days (emergency schedule)/28 days (routine schedule) after two-dose vaccination
Immunogenicity indexes of the seroconversion rate, seropositive rate, GMT and GMI of neutralizing antibodies
The seroconversion rate, seropositive rate, GMT and GMI of neutralizing antibodies 28 days after the two doses (emergency schedule)
Immunogenicity indexes of the seroconversion rate, seropositive rate, GMT, and GMI in Phase Ⅱ
Phase Ⅱ:The seroconversion rate, seropositive rate, GMT, and GMI 28 days after the third dose（only for days 0,14,42 and days 0,28,56 schedule）
Immunogenicity indexes of the seropositivity rate, GMT, and GMI in Phase Ⅱ
Phase Ⅱ:The seropositivity rate, GMT, and GMI 14 day (emergency schedule)/28 days (routine schedule) after the booster dose （only for days 0,14 and days 0,28 schedule）
Immunogenicity indexes of the seroconversion rate, seropositive rate, GMT, and GMI in Phase Ⅰ
Phase Ⅰ:The seroconversion rate, seropositive rate, GMT, and GMI 7/14/21 days after the first dose vaccination (emergency schedule)
Immunogenicity indexes of the seroconversion rate, seropositive rate, GMT, and GMI in Phase Ⅰ
Phase Ⅰ:The seroconversion rate, seropositive rate, GMT, and GMI 28/35/42 days after the first dose vaccination (routine schedules)
Immunogenicity indexes of the seropositive rate of IgG, IgM antibodies
Phase Ⅰ:The seropositive rate of IgG, IgM antibodies 7/14/21/28/42 days after the first dose vaccination (emergency schedule)
Immunogenicity indexes of the seropositive rate of IgG,IgM antibodies
Phase Ⅰ: The seropositive rate of IgG,IgM antibodies 28/35/42/56 days after the first dose vaccination (routine schedule)
Full Information
NCT ID
NCT04352608
First Posted
April 14, 2020
Last Updated
February 22, 2022
Sponsor
Sinovac Research and Development Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04352608
Brief Title
Safety and Immunogenicity Study of Inactivated Vaccine for Prophylaxis of SARS CoV-2 Infection (COVID-19)
Official Title
A Randomized, Double-Blinded, Placebo-Controlled, Phase Ⅰ/Ⅱ Clinical Trial, to Evaluate the Safety and Immunogenicity of the SARS-CoV-2 Inactivated Vaccine in Healthy Adults Aged 18~59 Years
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
April 16, 2020 (Actual)
Primary Completion Date
July 10, 2020 (Actual)
Study Completion Date
July 24, 2021 (Actual)
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
Yes
5. Study Description
Brief Summary
This study is a randomized, double-blinded, and placebo controlled phase Ⅰ/Ⅱ clinical trial of the SARS-CoV-2 inactivated vaccine manufactured by Sinovac Research & Development Co., Ltd. The purpose of this study is to evaluate the safety and immunogenicity of the experimental vaccine in healthy adults aged 18~59 Years.
Detailed Description
This study is a randomized, double-blinded, single-center, placebo-controlled phase Ⅰ/Ⅱ clinical trial in adults aged 18~59 years. The purpose of this study is to evaluate the immunogenicity and safety of the experimental SARS-CoV-2 inactivated vaccine. The experimental vaccine and placebo were both manufactured by Sinovac Research & Development Co., Ltd. A total of 744 subjects will be enrolled, with 144 at phase Ⅰ, and 600 at phase Ⅱ. All of participants in phase Ⅰ will be assigned to receive two doses of experimental vaccine or placebo on the schedule of day 0,14 or day 0,28.300 participants in phase Ⅱ will be assigned to receive two doses of experimental vaccine or placebo on the schedule of day 0,14 or day 0,28 and one dose of booster immunization will be given 6 months after primary immunization of day 0,14 or day 0,28.The other 300 participants in phase Ⅱ will be assigned to receive three doses of experimental vaccine or placebo on the schedule of day 0,14,42 or 0,28,56 .
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 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
744 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Emergency schedule & Two doses of medium dosage vaccine
Arm Type
Experimental
Arm Description
24 participants in phase Ⅰand 60 participants in phase Ⅱ will receive two doses of medium dosage inactivated SARS-CoV-2 vaccine at the emergency vaccination schedule,and 60 participants in phase Ⅱ will receive one dose of booster immunization with medium dosage vaccine 6 months after the emergency schedule
Arm Title
Emergency schedule & Two doses of high dosage vaccine
Arm Type
Experimental
Arm Description
24 participants in phase Ⅰand 60 participants in phase Ⅱ will receive two doses of high dosage inactivated SARS-CoV-2 vaccine at the emergency vaccination schedule,and 60 participants in phase Ⅱ will receive one dose of booster immunization with high dosage vaccine 6 months after the emergency schedule
Arm Title
Emergency schedule &Two doses of placebo
Arm Type
Placebo Comparator
Arm Description
24 participants in phase Ⅰand 30 participants in phase Ⅱ will receive two doses of placebo at the emergency vaccination schedule,and 30 participants in phase Ⅱ will receive one dose of booster immunization with placebo 6 months after the emergency schedule
Arm Title
Routine schedule & Two doses of medium dosage vaccine
Arm Type
Experimental
Arm Description
24 participants in phase Ⅰand 60 participants in phase Ⅱ will receive two doses of medium dosage inactivated SARS-CoV-2 vaccine at the routine vaccination schedule,and 60 participants in phase Ⅱ will receive one dose of booster immunization with medium dosage vaccine 6 months after the routine schedule
Arm Title
Routine schedule &Two doses of high dosage vaccine
Arm Type
Experimental
Arm Description
24 participants in phase Ⅰand 60 participants in phase Ⅱ will receive two doses of high dosage inactivated SARS-CoV-2 vaccine at the routine vaccination schedule,and 60 participants in phase Ⅱ will receive one dose of booster immunization with high dosage vaccine 6 months after the routine schedule
Arm Title
Routine schedule & Two doses of placebo
Arm Type
Placebo Comparator
Arm Description
24 participants in phase Ⅰand 30 participants in phase Ⅱ will receive two doses of placebo at the routine vaccination schedule,and 30 participants in phase Ⅱ will receive one dose of booster immunization with placebo 6 months after the routine schedule
Arm Title
Emergency schedule & Three doses of medium dosage vaccine
Arm Type
Experimental
Arm Description
60 participants in phase Ⅱ will receive three doses of medium dosage inactivated SARS-CoV-2 vaccine at the emergency vaccination schedule
Arm Title
Emergency schedule & Three doses of high dosage vaccine
Arm Type
Experimental
Arm Description
60 participants in phase Ⅱ will receive three doses of high dosage inactivated SARS-CoV-2 vaccine at the emergency vaccination schedule
Arm Title
Emergency schedule &Three doses of placebo
Arm Type
Placebo Comparator
Arm Description
30 participants in phase Ⅱ will receive three doses of placebo at the emergency vaccination schedule
Arm Title
Routine schedule & Three doses of medium dosage vaccine
Arm Type
Experimental
Arm Description
60 participants in phase Ⅱ will receive three doses of medium dosage inactivated SARS-CoV-2 vaccine at the routine vaccination schedule
Arm Title
Routine schedule &Three doses of high dosage vaccine
Arm Type
Experimental
Arm Description
60 participants in phase Ⅱ will receive three doses of high dosage inactivated SARS-CoV-2 vaccine at the routine vaccination schedule
Arm Title
Routine schedule &Three doses of placebo
Arm Type
Placebo Comparator
Arm Description
30 participants in phase Ⅱ will receive three doses of placebo at the routine vaccination schedule
Intervention Type
Biological
Intervention Name(s)
Two doses of medium dosage inactivated SARS-CoV-2 vaccine at the emergency vaccination schedule
Intervention Description
Two doses of medium dosage (600SU/0.5ml) experimental vaccine at the schedule of day 0,14,and one dose of booster immunization with medium dosage (600SU/0.5ml) experimental vaccine 6 months after the schedule of day 0,14 in phaseⅡ.
Intervention Type
Biological
Intervention Name(s)
Two doses of high dosage inactivated SARS-CoV-2 vaccine at the emergency vaccination schedule
Intervention Description
Two doses of high dosage (1200 SU/0.5ml) experimental vaccine at the schedule of day 0,14 and one dose of booster immunization with high dosage (1200SU/0.5ml) experimental vaccine 6 months after the schedule of day 0,14 in phaseⅡ.
Intervention Type
Biological
Intervention Name(s)
Two doses of placebo at the emergency vaccination schedule
Intervention Description
Two doses of placebo at the schedule of day 0,14 and one dose of booster immunization with placebo 6 months after the schedule of day 0,14 in phaseⅡ.
Intervention Type
Biological
Intervention Name(s)
Two doses of medium dosage inactivated SARS-CoV-2 vaccine at the routine vaccination schedule
Intervention Description
Two doses of medium dosage (600SU/0.5ml) experimental vaccine at the schedule of day 0,28 and one dose of booster immunization with medium dosage (600SU/0.5ml) experimental vaccine 6 months after the schedule of day 0,28 in phaseⅡ.
Intervention Type
Biological
Intervention Name(s)
Two doses of high dosage inactivated SARS-CoV-2 vaccine at the routine vaccination schedule
Intervention Description
Two doses of high dosage (1200 SU/0.5ml) experimental vaccine at the schedule of day 0,28 and one dose of booster immunization with high dosage (1200SU/0.5ml) experimental vaccine 6 months after the schedule of day 0,28 in phaseⅡ
Intervention Type
Biological
Intervention Name(s)
Two doses of placebo at the routine vaccination schedule
Intervention Description
Two doses of placebo at the schedule of day 0,28 and one dose of booster immunization with placebo 6 months after the schedule of day 0,28 in phaseⅡ.
Intervention Type
Biological
Intervention Name(s)
Three doses of medium dosage inactivated SARS-CoV-2 vaccine at the emergency vaccination schedule
Intervention Description
Three doses of medium dosage (600SU/0.5ml) experimental vaccine at the schedule of day 0,14,42
Intervention Type
Biological
Intervention Name(s)
Three doses of high dosage inactivated SARS-CoV-2 vaccine at the emergency vaccination schedule
Intervention Description
Three doses of high dosage (1200 SU/0.5ml) experimental vaccine at the schedule of day 0,14,42
Intervention Type
Biological
Intervention Name(s)
Three doses of placebo at the emergency vaccination schedule
Intervention Description
Three doses of placebo at the schedule of day 0,14,42
Intervention Type
Biological
Intervention Name(s)
Three doses of medium dosage inactivated SARS-CoV-2 vaccine at the routine vaccination schedule
Intervention Description
Three doses of medium dosage (600SU/0.5ml) experimental vaccine at the schedule of day 0,28,56
Intervention Type
Biological
Intervention Name(s)
Three doses of high dosage inactivated SARS-CoV-2 vaccine at the routine vaccination schedule
Intervention Description
Three doses of high dosage (1200 SU/0.5ml) experimental vaccine at the schedule of day 0,28,56
Intervention Type
Biological
Intervention Name(s)
Three doses of placebo at the routine vaccination schedule
Intervention Description
Three doses of placebo at the schedule of day 0,28,56
Primary Outcome Measure Information:
Title
Safety indexes of adverse reactions
Description
Incidence of adverse reactions occured from Day 0 to Day 28 after each dose
Time Frame
From Day 0 to Day 28 after each dose
Title
Immunogenicity indexes of neutralizing-antibody seroconversion rates
Description
The seroconversion rate of neutralizing antibodies 14 days (emergency schedule)/28 days (routine schedule) after the two-dose vaccination.
Time Frame
The 14th day /the 28th day after two doses of vaccination
Secondary Outcome Measure Information:
Title
Safety indexes of adverse reactions
Description
Incidence of adverse reactions 7 days after each dose of vaccination
Time Frame
7 days after each dose of vaccination
Title
Safety indexes of Incidence of abnormal laboratory index
Description
Incidence of abnormal laboratory index (blood routine test, blood chemistry test,and urine routine test) on the 3th day after each dose of vaccination in phase Ⅰ
Time Frame
On the 3th day after each dose of vaccination in phase Ⅰ
Title
Safety indexes of serious adverse events (SAEs）
Description
Incidence of SAEs from the beginning of the vaccination to 6 months post the whole-schedule vaccination
Time Frame
From the beginning of the vaccination to 6 months post the whole-schedule vaccination
Title
Immunogenicity indexes of the seropositive rate, GMT, and GMI of neutralizing antibodies
Description
The seropositive rate, GMT, and GMI of neutralizing antibodies 14 days (emergency schedule)/28 days (routine schedule) after two-dose vaccination
Time Frame
14 days (emergency schedule)/28 days (routine schedule) after two-dose vaccination
Title
Immunogenicity indexes of the seroconversion rate, seropositive rate, GMT and GMI of neutralizing antibodies
Description
The seroconversion rate, seropositive rate, GMT and GMI of neutralizing antibodies 28 days after the two doses (emergency schedule)
Time Frame
28 days after the two doses (emergency schedule)
Title
Immunogenicity indexes of the seroconversion rate, seropositive rate, GMT, and GMI in Phase Ⅱ
Description
Phase Ⅱ:The seroconversion rate, seropositive rate, GMT, and GMI 28 days after the third dose（only for days 0,14,42 and days 0,28,56 schedule）
Time Frame
28 days after the third dose （only for days 0,14,42 and days 0,28,56 schedule）
Title
Immunogenicity indexes of the seropositivity rate, GMT, and GMI in Phase Ⅱ
Description
Phase Ⅱ:The seropositivity rate, GMT, and GMI 14 day (emergency schedule)/28 days (routine schedule) after the booster dose （only for days 0,14 and days 0,28 schedule）
Time Frame
14 day (emergency schedule)/28 days (routine schedule) after the booster dose （only for days 0,14 and days 0,28 schedule）
Title
Immunogenicity indexes of the seroconversion rate, seropositive rate, GMT, and GMI in Phase Ⅰ
Description
Phase Ⅰ:The seroconversion rate, seropositive rate, GMT, and GMI 7/14/21 days after the first dose vaccination (emergency schedule)
Time Frame
7/14/21 days after the first dose vaccination (emergency schedule)
Title
Immunogenicity indexes of the seroconversion rate, seropositive rate, GMT, and GMI in Phase Ⅰ
Description
Phase Ⅰ:The seroconversion rate, seropositive rate, GMT, and GMI 28/35/42 days after the first dose vaccination (routine schedules)
Time Frame
28/35/42 days after the first dose vaccination (routine schedules)
Title
Immunogenicity indexes of the seropositive rate of IgG, IgM antibodies
Description
Phase Ⅰ:The seropositive rate of IgG, IgM antibodies 7/14/21/28/42 days after the first dose vaccination (emergency schedule)
Time Frame
7/14/21/28/42 days after the first dose vaccination (emergency schedule)
Title
Immunogenicity indexes of the seropositive rate of IgG,IgM antibodies
Description
Phase Ⅰ: The seropositive rate of IgG,IgM antibodies 28/35/42/56 days after the first dose vaccination (routine schedule)
Time Frame
28/35/42/56 days after the first dose vaccination (routine schedule)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy adults aged 18-59 years;
Proven legal identity;
Participants should be capable of understanding the informed consent form, and such form should be signed prior to enrolment ;
Exclusion Criteria:
Travel history / residence history of Wuhan city and surrounding areas, or other communities with case reports within 14 days;
History of contact with a SARS-CoV-2 infection (positive in nucleic acid test) within 14 days;
Have contacted patients with fever or respiratory symptoms from Wuhan and surrounding areas, or from communities with case reports within 14 days;
Have contacted patients with fever or respiratory symptoms from Wuhan and surrounding areas, or from communities with case reports within 14 days;
Self-reported history of SARS;
Self-reported history of new coronavirus infection;
Positive in serum antibodies (IgG or IgM) screening of COVID-19;
Positive in nasopharyngeal swabs or anal swabs through RT-PCR;
Women who are breastfeeding, pregnant or planning to become pregnant during the study period;
BMI≥35 kg/m2;
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 or immunodeficiency / immunosuppression;
Suffering from severe chronic diseases, severe cardiovascular diseases, hypertension and diabetes that cannot be controlled by drugs, liver and 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 non-complicated dermatitis superficial corticosteroid therapy) in the past 6 months;
Abnormal laboratory test results in the physical examination such as clinically significant abnormal hematology and biochemistry beyond the reference value range (only applicable to Phase I clinical trials);
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;
Attacks of acute diseases or chronic diseases in the past 7 days;
Axillary temperature >37.0°C;
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
Fengcai Zhu, Doctor
Organizational Affiliation
Jiangsu Provincial Center for Disease Control and Prevention
Official's Role
Principal Investigator
Facility Information:
Facility Name
Suining County Center for Disease Control and Prevention
City
Xuzhou
State/Province
Jiangsu
ZIP/Postal Code
221200
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
35660738
Citation
Xin Q, Wu Q, Chen X, Han B, Chu K, Song Y, Jin H, Chen P, Lu W, Yang T, Li M, Zhao Y, Pan H, Yu H, Wang L. Six-month follow-up of a booster dose of CoronaVac in two single-centre phase 2 clinical trials. Nat Commun. 2022 Jun 3;13(1):3100. doi: 10.1038/s41467-022-30864-w.
Results Reference
derived
PubMed Identifier
34890537
Citation
Zeng G, Wu Q, Pan H, Li M, Yang J, Wang L, Wu Z, Jiang D, Deng X, Chu K, Zheng W, Wang L, Lu W, Han B, Zhao Y, Zhu F, Yu H, Yin W. Immunogenicity and safety of a third dose of CoronaVac, and immune persistence of a two-dose schedule, in healthy adults: interim results from two single-centre, double-blind, randomised, placebo-controlled phase 2 clinical trials. Lancet Infect Dis. 2022 Apr;22(4):483-495. doi: 10.1016/S1473-3099(21)00681-2. Epub 2021 Dec 8.
Results Reference
derived
PubMed Identifier
33217362
Citation
Zhang Y, Zeng G, Pan H, Li C, Hu Y, Chu K, Han W, Chen Z, Tang R, Yin W, Chen X, Hu Y, Liu X, Jiang C, Li J, Yang M, Song Y, Wang X, Gao Q, Zhu F. Safety, tolerability, and immunogenicity of an inactivated SARS-CoV-2 vaccine in healthy adults aged 18-59 years: a randomised, double-blind, placebo-controlled, phase 1/2 clinical trial. Lancet Infect Dis. 2021 Feb;21(2):181-192. doi: 10.1016/S1473-3099(20)30843-4. Epub 2020 Nov 17.
Results Reference
derived
Learn more about this trial
Safety and Immunogenicity Study of Inactivated Vaccine for Prophylaxis of SARS CoV-2 Infection (COVID-19)
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