COVID-19Phase 3NCT04582344
Clinical Trial For SARS-CoV-2 Vaccine (COVID-19)
A Phase 3 study testing CoronaVac in people with COVID-19, run by Health Institutes of Turkey at 25 sites in Turkey (Türkiye).
Trial summary
This study is a randomized, double-blinded, and placebo controlled phase III clinical trial of the SARS-CoV-2 inactivated vaccine manufactured by Sinovac Research \& Development Co., Ltd. Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- CoronaVac
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10,214 participants
- Where
- 25 sitesTurkey (Türkiye)
- Study dates
- 14 Sep 2020to 27 Jul 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-59 years of age (including 18 and 59 years of ages),
- For only K1 cohort, health care workers such as medical doctor, nurse, ward boy, cleaner, hospital technician, administrative personnel who work in any department of a hospital.
- Signed informed consent
Who cannot join
- Previously PCR positive for COVID-19
- IgG or IgM is positive
- For females: Pregnancy (confirmed by positive beta-hCG test), breastfeeding or intent to engage in sexual relations with reproductive intent without use of birth control methods in the three months following vaccination
- Known allergy to components of the study vaccine or control
- Use of immunosuppressant therapy regimens within the six months prior to enrollment in the study or planned use within the two years following enrollment. Immunosuppressant therapy regimens include: antineoplastic chemotherapy, radiation therapy and immunosuppressants to induce transplant tolerance, among others
- Use of immunosuppressive doses of corticosteroids within the three months prior to the enrollment in the study and planned use of immunosuppressive doses of corticoids within the three months following enrollment in the study. Immunosuppressive doses of corticosteroids will be considered the equivalent prednisone 20 mg/day for adults, for longer than one week. Continued use of topical or nasal corticosteroids is not considered an immunosuppressant
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- History of asplenia
- History of bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venipuncture
- Any alcohol or drug abuse over the 12 months prior to enrollment in the study that has caused medical, professional or family problems, indicated by clinical history
- Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate
- Participation in another clinical trial with an investigational product in the six months prior to enrollment in the study or planned participation in another clinical trial within the two years following enrollment
- Received live attenuated virus vaccine 14 days prior to enrollment in the study
- Inactivated vaccine or sub unit vaccine 7 days prior to enrollment in the study
- Fever (oral temperature >37.2℃, axillary temperature will not be accepted) within the past 24 hours
- Any other condition that, in the opinion of the principal investigator or his/her representative physician, could put the safety/rights of potential participants at risk or prevent them from complying with this protocol.
- Any confirmed or suspected autoimmune disease or immunodeficiency disease, including human immunodeficiency virus (HIV) infection.
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
Turkey (Türkiye)25 sites
Çukurova University Faculty of Medicine, Department of Infectious Diseases
Adana
T.R. Ministry of Health Ankara City Hospital, Infectious Diseases and Clinical Microbiology Clinic
Ankara, Turkey Region, 06800
T.R. Ministry of Health Ankara Provincial Health Directorate Ankara Training and Research Hospital, Infectious Diseases
Ankara, Turkey Region, 06800
Ankara University Faculty of Medicine, Department of Infectious Diseases and Clinical Microbiology
Ankara, Turkey Region
Hacettepe University Faculty of Medicine Department of Infections Diseases and Clinical Microbiology
Ankara
T.C Ministry of Health Ankara Provincial Health Directorate Health Sciences University Ankara Atatürk Chest Diseases and Thoracic Surgery Training and Research Hospital
Ankara
Akdeniz University Faculty of Medicine, Department of Infectious Diseases
Antalya
Bursa Uludağ University Faculty of Medicine, Department of Infectious Diseases and Clinical Microbiology
Bursa
Dicle University Faculty of Medicine, Department of Infectious Diseases and Clinical Microbiology
Diyarbakır
Gaziantep University Faculty of Medicine, Department of Infectious Diseases and Clinical Microbiology
Gaziantep
Acıbadem Atakent Hospital, Infectious Diseases and Clinical Microbiology
Istanbul
Cerrahpaşa Faculty of Medicine, Department of Internal Medicine - Department of Infectious Diseases and Clinical Microbiology
Istanbul
Istanbul Medipol University Faculty of Medicine, Department of Internal Medicine
Istanbul
Istanbul University Istanbul Faculty of Medicine, Department of Infectious Diseases and Clinical Microbiology
Istanbul
T.R. Ministry of Health Istanbul Provincial Health Directorate Marmara Univesity Istanbul Pendik Education and Research Hospital
Istanbul
T.R. Ministry of Health Istanbul Provincial Health Directorate Prof. Dr. Cemil Taşçıoğlu City Hospital, Infectious Diseases Clinic
Istanbul
T.R. Ministry of Health Istanbul Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital
Istanbul
University of Health Sciences İstanbul Ümraniye Training and Research Hospital
Istanbul
Ege University Faculty of Medicine Hospital, Department of Infectious Diseasesaculty of Medicine Hospital, Department of Infectious Diseases
Izmir
Republic Of Turkey Ministry Of Health Izmir Provincial Health Directorate Health Sciences University Dr Suat Seren Chest Diseases And Chest Surgery Training And Research Hospital
Izmir
T.R. Ministry of Health İzmir Provincial Health Directorate İzmir Health Sciences University Tepecik Training and Research Hospital, Infectious Diseases
Izmir
T.R. Ministry of Health Kayseri City Training and Research Hospital, Infectious Diseases and Clinical Microbiology Department
Kayseri
Kocaeli University Faculty of Medicine, Department of Infectious Diseases and Clinical Microbiology
Kocaeli
Malatya İnönü University Faculty of Medicine, Department of Infectious Diseases
Malatya
Karadeniz Technical University Medical Faculty Hospital, Department of Infectious Diseases and Clinical Microbiology
Trabzon
About this study
Official title: Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Trial For Evaluation of Efficacy and Safety of SARS-CoV-2 Vaccine (Vero Cell), Inactivated
This study is a randomized, double-blinded, and placebo controlled phase III 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 efficacy, safety and immunogenicity of the experimental vaccine in healthy adults aged 18~59 Years.
Read the detailed description
This study is a randomized, double-blinded, multi-center, placebo-controlled phase III clinical trial in adults aged 18~59 years. The purpose of this study is to evaluate the efficacy, safety and immunogenicity 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 13.000 subjects will be enrolled. Participant will be assigned to receive two doses of experimental vaccine or placebo on the schedule of day 0,14. It is planned that the study will be conducted with two separate cohorts. The first cohort will be healthcare workers in the high risk group (K-1) and the second cohort will be people at normal risk (K-2). After 2 doses of vaccination of 1300 volunteers are completed, safety data will be evaluated by the data safety monitoring board without breaking the blinding, and if there is no safety issue, the K2 cohort will continue to be vaccinated.1.300 volunteers, including 650 volunteers SARS-CoV-2 vaccine and placebo arms, will be included in the K-1 cohort. In the K-2 cohort (normal risk group for COVID-19), 7.650 volunteers were planned to be included in the SARS-CoV-2 vaccine group, and 3.500 volunteers in the placebo group.
- Conditions
- COVID-19
- Being tested
- CoronaVac, Placebo
- Keywords
- COVID-19, SARS-CoV-2 Vaccine
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CoronaVacBiological
Two doses at 14-day interval, each inoculation dose is 0.5 mL. Two doses of dosage (each prefilled syringe of the vaccine contains 600 SU of SARS-CoV-2 virus antigen) experimental vaccine at the schedule of day 0,14
PlaceboBiological
Aluminium hydroxide, disodium hydrogen phosphate, sodium dihydrogen phosphate, sodium chloride 0.5mL/dose, two doses given 14 days apart.
| Study group | Role | What they receive |
|---|---|---|
| SARS-COV-2 Vaccine | Experimental | 600 SU of SARS-CoV-2 virus antigen, intramuscular injection, two doses given 14 days apart. Receives: Biological: CoronaVac |
| Placebo | Placebo comparator | Aluminium hydroxide, disodium hydrogen phosphate, sodium dihydrogen phosphate, sodium chloride 0.5mL/dose, intramuscular injection, two doses given 14 days apart. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Protection Indexes of Two Vaccine Doses For Symptomatic COVID-19
The protection rate of a two-dose of SARS-CoV-2 (Vero Cell) vaccine against RT-PCR confirmed symptomatic COVID-19
Measured: 2 weeks after the second dose of vaccination
Secondary outcomes (10)
Protection Indexes of One Vaccine Dose For Symptomatic COVID-19
The protection rate of, at least, one dose of SARS-CoV-2 (Vero Cell) vaccine against RT-PCR confirmed symptomatic COVID-19 Two weeks after the last dose vaccination.
Measured: 2 weeks after the second dose of vaccination
Protection Indexes of Second Vaccine Dose For Hospitalization, Disease Severity/and Death
The protection rate of a two-dose of SARS-CoV-2 (Vero Cell) vaccine against rates of hospitalization, disease severity/and death two weeks after the second dose of vaccination
Measured: 2 weeks after the second dose of vaccination
Protection Indexes of Two Vaccine Doses For SARS-CoV-2 infection
The protection rate of a two dose of SARS-CoV-2 (Vero Cell) vaccine against RT-PCR confirmed SARS-CoV-2 infection two weeks after the second dose of vaccination
Measured: 2 weeks after the second dose of vaccination
Safety indexes of adverse reactions in 28 days
The incidence of adverse reactions from the day of first vaccination to 28 days after the second dose of vaccination.
Measured: 28 days after the second dose of vaccination
Safety indexes of adverse reactions in 7 days
The incidence of adverse reactions within 7 days after each dose of vaccination
Measured: 7 days after each dose of vaccination
Safety indexes of serious adverse events in 1 year
The incidence of SAEs from the first vaccination to one year after the second dose vaccination
Measured: 1 year after second dose of vaccination
Immunogenicity parameters (seroconversion rate, seropositivity rate) in 14 days
The seroconversion rate, seropositivity rate 14 days after each dose vaccination
Measured: 14 days after each dose vaccination
Immunogenicity parameters (seroconversion rate, seropositivity rate) in 28 days
The seroconversion rate, seropositive rate 28 days after the second dose vaccination
Measured: 28 days after the second dose vaccination
Immunogenicity parameters (GMT and GMI of neutralizing antibody and IgG) in 14 days
GMT and GMI of neutralizing antibody and IgG 14 days after each dose vaccination
Measured: 14 days after each dose vaccination
Immunogenicity parameters (GMT and GMI of neutralizing antibody and IgG) in 28 days
GMT and GMI of neutralizing antibody and IgG 28 days after the second dose vaccination
Measured: 28 days after the second dose vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2020
- Study start14 Sep 2020
- Primary completion30 Jun 2022
- Study completion27 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 10,214 participants (actual)
Sponsor and investigators
- Lead sponsor
- Health Institutes of Turkey
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Murat Akova, Prof., Principal investigator, Faculty Member
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04582344
- Sponsor's protocol ID
- 9026-ASI
- Status last verified
- Aug 2022
- First submitted
- 1 Oct 2020
- Last updated
- 24 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gao Q, Bao L, Mao H, Wang L, Xu K, Yang M, Li Y, Zhu L, Wang N, Lv Z, Gao H, Ge X, Kan B, Hu Y, Liu J, Cai F, Jiang D, Yin Y, Qin C, Li J, Gong X, Lou X, Shi W, Wu D, Zhang H, Zhu L, Deng W, Li Y, Lu J, Li C, Wang X, Yin W, Zhang Y, Qin C. Development of an inactivated vaccine candidate for SARS-CoV-2. Science. 2020 Jul 3;369(6499):77-81. doi: 10.1126/science.abc1932. Epub 2020 May 6.
PubMed 32376603Luan N, Li T, Wang Y, Cao H, Yin X, Lin K, Liu C. Th2-Oriented Immune Serum After SARS-CoV-2 Vaccination Does Not Enhance Infection In Vitro. Front Immunol. 2022 Apr 8;13:882856. doi: 10.3389/fimmu.2022.882856. eCollection 2022.
PubMed 35464483Tanriover MD, Doganay HL, Akova M, Guner HR, Azap A, Akhan S, Kose S, Erdinc FS, Akalin EH, Tabak OF, Pullukcu H, Batum O, Simsek Yavuz S, Turhan O, Yildirmak MT, Koksal I, Tasova Y, Korten V, Yilmaz G, Celen MK, Altin S, Celik I, Bayindir Y, Karaoglan I, Yilmaz A, Ozkul A, Gur H, Unal S; CoronaVac Study Group. Efficacy and safety of an inactivated whole-virion SARS-CoV-2 vaccine (CoronaVac): interim results of a double-blind, randomised, placebo-controlled, phase 3 trial in Turkey. Lancet. 2021 Jul 17;398(10296):213-222. doi: 10.1016/S0140-6736(21)01429-X. Epub 2021 Jul 8.
PubMed 34246358Akova M, Unal S. A randomized, double-blind, placebo-controlled phase III clinical trial to evaluate the efficacy and safety of SARS-CoV-2 vaccine (inactivated, Vero cell): a structured summary of a study protocol for a randomised controlled trial. Trials. 2021 Apr 13;22(1):276. doi: 10.1186/s13063-021-05180-1.
PubMed 33849629
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Trial For Evaluation of Efficacy and Safety of SARS-CoV-2 Vaccine (Vero Cell), Inactivated
- ClinicalTrials.gov ID
- NCT04582344
- Acronym / sponsor ID
- 9026-ASI
- Conditions
- COVID-19
- Keywords
- COVID-19, SARS-CoV-2 Vaccine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10,214 participants (actual)
- Lead sponsor
- Health Institutes of TurkeyOther government
- Study start
- 14 Sep 2020 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 27 Jul 2022 (actual)
- First posted
- 9 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a randomized, double-blinded, and placebo controlled phase III 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 efficacy, safety and immunogenicity of the experimental vaccine in healthy adults aged 18~59 Years.
Detailed description
This study is a randomized, double-blinded, multi-center, placebo-controlled phase III clinical trial in adults aged 18~59 years. The purpose of this study is to evaluate the efficacy, safety and immunogenicity 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 13.000 subjects will be enrolled. Participant will be assigned to receive two doses of experimental vaccine or placebo on the schedule of day 0,14. It is planned that the study will be conducted with two separate cohorts. The first cohort will be healthcare workers in the high risk group (K-1) and the second cohort will be people at normal risk (K-2). After 2 doses of vaccination of 1300 volunteers are completed, safety data will be evaluated by the data safety monitoring board without breaking the blinding, and if there is no safety issue, the K2 cohort will continue to be vaccinated.1.300 volunteers, including 650 volunteers SARS-CoV-2 vaccine and placebo arms, will be included in the K-1 cohort. In the K-2 cohort (normal risk group for COVID-19), 7.650 volunteers were planned to be included in the SARS-CoV-2 vaccine group, and 3.500 volunteers in the placebo group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| SARS-COV-2 Vaccine | Experimental | Biological: CoronaVac600 SU of SARS-CoV-2 virus antigen, intramuscular injection, two doses given 14 days apart. |
| Placebo | Placebo comparator | Biological: PlaceboAluminium hydroxide, disodium hydrogen phosphate, sodium dihydrogen phosphate, sodium chloride 0.5mL/dose, intramuscular injection, two doses given 14 days apart. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 18-59 years of age (including 18 and 59 years of ages),
- For only K1 cohort, health care workers such as medical doctor, nurse, ward boy, cleaner, hospital technician, administrative personnel who work in any department of a hospital.
- Signed informed consent
Key exclusion criteria (16 listed)
- Previously PCR positive for COVID-19
- IgG or IgM is positive
- For females: Pregnancy (confirmed by positive beta-hCG test), breastfeeding or intent to engage in sexual relations with reproductive intent without use of birth control methods in the three months following vaccination
- Known allergy to components of the study vaccine or control
- Use of immunosuppressant therapy regimens within the six months prior to enrollment in the study or planned use within the two years following enrollment. Immunosuppressant therapy regimens include: antineoplastic chemotherapy, radiation therapy and immunosuppressants to induce transplant tolerance, among others
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CoronaVacTwo doses at 14-day interval, each inoculation dose is 0.5 mL. Two doses of dosage (each prefilled syringe of the vaccine contains 600 SU of SARS-CoV-2 virus antigen) experimental vaccine at the schedule of day 0,14 | Biological | SARS-COV-2 Vaccine |
| PlaceboAluminium hydroxide, disodium hydrogen phosphate, sodium dihydrogen phosphate, sodium chloride 0.5mL/dose, two doses given 14 days apart. | Biological | Placebo |
Primary outcome
Protection Indexes of Two Vaccine Doses For Symptomatic COVID-19
Time frame: 2 weeks after the second dose of vaccination
The protection rate of a two-dose of SARS-CoV-2 (Vero Cell) vaccine against RT-PCR confirmed symptomatic COVID-19
10 secondary outcomes
Protection Indexes of One Vaccine Dose For Symptomatic COVID-19
Time frame: 2 weeks after the second dose of vaccination
Protection Indexes of Second Vaccine Dose For Hospitalization, Disease Severity/and Death
Time frame: 2 weeks after the second dose of vaccination
Protection Indexes of Two Vaccine Doses For SARS-CoV-2 infection
Time frame: 2 weeks after the second dose of vaccination
Safety indexes of adverse reactions in 28 days
Time frame: 28 days after the second dose of vaccination
Safety indexes of adverse reactions in 7 days
Time frame: 7 days after each dose of vaccination
Safety indexes of serious adverse events in 1 year
Time frame: 1 year after second dose of vaccination
Immunogenicity parameters (seroconversion rate, seropositivity rate) in 14 days
Time frame: 14 days after each dose vaccination
Immunogenicity parameters (seroconversion rate, seropositivity rate) in 28 days
Time frame: 28 days after the second dose vaccination
Immunogenicity parameters (GMT and GMI of neutralizing antibody and IgG) in 14 days
Time frame: 14 days after each dose vaccination
Immunogenicity parameters (GMT and GMI of neutralizing antibody and IgG) in 28 days
Time frame: 28 days after the second dose vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2024.
- Background: PubMed 32376603Gao Q, Bao L, Mao H, Wang L, Xu K, Yang M, Li Y, Zhu L, Wang N, Lv Z, Gao H, Ge X, Kan B, Hu Y, Liu J, Cai F, Jiang D, Yin Y, Qin C, Li J, Gong X, Lou X, Shi W, Wu D, Zhang H, Zhu L, Deng W, Li Y, Lu J, Li C, Wang X, Yin W, Zhang Y, Qin C. Development of an inactivated vaccine candidate for SARS-CoV-2. Science. 2020 Jul 3;369(6499):77-81. doi: 10.1126/science.abc1932. Epub 2020 May 6.
- Derived from this study: PubMed 35464483Luan N, Li T, Wang Y, Cao H, Yin X, Lin K, Liu C. Th2-Oriented Immune Serum After SARS-CoV-2 Vaccination Does Not Enhance Infection In Vitro. Front Immunol. 2022 Apr 8;13:882856. doi: 10.3389/fimmu.2022.882856. eCollection 2022.
- Derived from this study: PubMed 34246358Tanriover MD, Doganay HL, Akova M, Guner HR, Azap A, Akhan S, Kose S, Erdinc FS, Akalin EH, Tabak OF, Pullukcu H, Batum O, Simsek Yavuz S, Turhan O, Yildirmak MT, Koksal I, Tasova Y, Korten V, Yilmaz G, Celen MK, Altin S, Celik I, Bayindir Y, Karaoglan I, Yilmaz A, Ozkul A, Gur H, Unal S; CoronaVac Study Group. Efficacy and safety of an inactivated whole-virion SARS-CoV-2 vaccine (CoronaVac): interim results of a double-blind, randomised, placebo-controlled, phase 3 trial in Turkey. Lancet. 2021 Jul 17;398(10296):213-222. doi: 10.1016/S0140-6736(21)01429-X. Epub 2021 Jul 8.
- Derived from this study: PubMed 33849629Akova M, Unal S. A randomized, double-blind, placebo-controlled phase III clinical trial to evaluate the efficacy and safety of SARS-CoV-2 vaccine (inactivated, Vero cell): a structured summary of a study protocol for a randomised controlled trial. Trials. 2021 Apr 13;22(1):276. doi: 10.1186/s13063-021-05180-1.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Murat Akova, Prof. principal investigator
Faculty Member
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CoronaVac in people with COVID-19, run by Health Institutes of Turkey at 25 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Protection Indexes of Two Vaccine Doses For Symptomatic COVID-19 (time frame: 2 weeks after the second dose of vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04582344, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2024.