Safety and Immunogenicity Study of Inactivated Vaccine for Prophylaxis of SARS CoV-2 Infection (COVID-19)
NCT ID: NCT04352608
Last Updated: 2022-02-24
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1/PHASE2
744 participants
INTERVENTIONAL
2020-04-16
2021-07-24
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Safety and Immunogenicity Study of an Inactivated SARS-CoV-2 Vaccine for Preventing Against COVID-19
NCT04412538
Immunogenicity and Safety of Recombinant COVID-19 Vaccine (CHO Cells)
NCT04813562
A Phase I/II Clinical Trial in Healthy People Aged 18 Years and Above
NCT05144139
Phase I Trial of a Recombinant SARS-CoV-2 Vaccine (Sf9 Cell)
NCT04530656
Study of the Commercial Scale SARS-CoV-2 Vaccine Against the Pilot Scale Among Adults, and Bridging Study of the Immunogenicity in Elderly Against That in Adults
NCT04617483
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Emergency schedule & Two doses of medium dosage vaccine
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
Two doses of medium dosage inactivated SARS-CoV-2 vaccine at the emergency vaccination schedule
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.
Emergency schedule & Two doses of high dosage vaccine
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
Two doses of high dosage inactivated SARS-CoV-2 vaccine at the emergency vaccination schedule
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.
Emergency schedule &Two doses of placebo
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
Two doses of placebo at the emergency vaccination schedule
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.
Routine schedule & Two doses of medium dosage vaccine
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
Two doses of medium dosage inactivated SARS-CoV-2 vaccine at the routine vaccination schedule
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.
Routine schedule &Two doses of high dosage vaccine
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
Two doses of high dosage inactivated SARS-CoV-2 vaccine at the routine vaccination schedule
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
Routine schedule & Two doses of placebo
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
Two doses of placebo at the routine vaccination schedule
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.
Emergency schedule & Three doses of medium dosage vaccine
60 participants in phase Ⅱ will receive three doses of medium dosage inactivated SARS-CoV-2 vaccine at the emergency vaccination schedule
Three doses of medium dosage inactivated SARS-CoV-2 vaccine at the emergency vaccination schedule
Three doses of medium dosage (600SU/0.5ml) experimental vaccine at the schedule of day 0,14,42
Emergency schedule & Three doses of high dosage vaccine
60 participants in phase Ⅱ will receive three doses of high 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 high dosage (1200 SU/0.5ml) experimental vaccine at the schedule of day 0,14,42
Emergency schedule &Three doses of placebo
30 participants in phase Ⅱ will receive three doses of placebo at the emergency vaccination schedule
Three doses of placebo at the emergency vaccination schedule
Three doses of placebo at the schedule of day 0,14,42
Routine schedule & Three doses of medium dosage vaccine
60 participants in phase Ⅱ will receive three doses of medium dosage inactivated SARS-CoV-2 vaccine at the routine vaccination schedule
Three doses of medium dosage inactivated SARS-CoV-2 vaccine at the routine vaccination schedule
Three doses of medium dosage (600SU/0.5ml) experimental vaccine at the schedule of day 0,28,56
Routine schedule &Three doses of high dosage vaccine
60 participants in phase Ⅱ will receive three doses of high 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 high dosage (1200 SU/0.5ml) experimental vaccine at the schedule of day 0,28,56
Routine schedule &Three doses of placebo
30 participants in phase Ⅱ will receive three doses of placebo at the routine vaccination schedule
Three doses of placebo at the routine vaccination schedule
Three doses of placebo at the schedule of day 0,28,56
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Two doses of medium dosage inactivated SARS-CoV-2 vaccine at the emergency vaccination schedule
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.
Two doses of high dosage inactivated SARS-CoV-2 vaccine at the emergency vaccination schedule
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.
Two doses of placebo at the emergency vaccination schedule
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.
Two doses of medium dosage inactivated SARS-CoV-2 vaccine at the routine vaccination schedule
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.
Two doses of high dosage inactivated SARS-CoV-2 vaccine at the routine vaccination schedule
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
Two doses of placebo at the routine vaccination schedule
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.
Three doses of medium dosage inactivated SARS-CoV-2 vaccine at the emergency vaccination schedule
Three doses of medium dosage (600SU/0.5ml) experimental vaccine at the schedule of day 0,14,42
Three doses of high dosage inactivated SARS-CoV-2 vaccine at the emergency vaccination schedule
Three doses of high dosage (1200 SU/0.5ml) experimental vaccine at the schedule of day 0,14,42
Three doses of placebo at the emergency vaccination schedule
Three doses of placebo at the schedule of day 0,14,42
Three doses of medium dosage inactivated SARS-CoV-2 vaccine at the routine vaccination schedule
Three doses of medium dosage (600SU/0.5ml) experimental vaccine at the schedule of day 0,28,56
Three doses of high dosage inactivated SARS-CoV-2 vaccine at the routine vaccination schedule
Three doses of high dosage (1200 SU/0.5ml) experimental vaccine at the schedule of day 0,28,56
Three doses of placebo at the routine vaccination schedule
Three doses of placebo at the schedule of day 0,28,56
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Proven legal identity;
* Participants should be capable of understanding the informed consent form, and such form should be signed prior to enrolment ;
Exclusion Criteria
* 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.
18 Years
59 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sinovac Research and Development Co., Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Fengcai Zhu, Doctor
Role: PRINCIPAL_INVESTIGATOR
Jiangsu Provincial Center for Disease Control and Prevention
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Suining County Center for Disease Control and Prevention
Xuzhou, Jiangsu, China
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PRO-nCOV-1001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.