Coronavirus Disease 2019Phase 3NCT05107375
Clinical Study of Recombinant Novel Coronavirus（COVID-19） Vaccine (CHO Cell) Combined With Influenza Vaccine
A Phase 3 study testing Tetravalent influenza virus lysis vaccine and Recombinant new coronavirus vaccine (CHO cell) group in people with Coronavirus Disease 2019, run by Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. at 1 site in China.
Trial summary
Popular topic：Clinical study of recombinant Novel Coronavirus vaccine (CHO cell) combined with influenza vaccine. Research purpose:Main purpose:To evaluate the immunogenicity of recombinant Novel Coronavirus vaccine (CHO cells) combined with influenza vaccine in people aged 18 years and over. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coronavirus Disease 2019
- What is being tested?
- Tetravalent influenza virus lysis vaccine and Recombinant new coronavirus vaccine (CHO cell) group
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 299 participants
- Where
- 1 siteChina
- Study dates
- 3 Sep 2021to 4 Mar 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy subjects aged 18 and above with full capacity for civil conduct, who can provide valid identification;
- The subjects voluntarily agree to participate in the study and sign the informed consent to understand and comply with the requirements of the study protocol;
- Fertile men and women of reproductive age did not have sex from day 1 of the last menstrual cycle to day 1 of the study, or did not have sex using effective contraceptive methods and did not experience contraceptive failure (examples of contraceptive failure include male condom rupture during sex). At the same time, subjects agreed to take effective contraceptive measures for 1 month from the signing of informed consent to the full immunization and no pregnancy plans during this period.
Who cannot join
- History of novel coronavirus infection confirmed or asymptomatic infected persons or positive nucleic acid test of novel Coronavirus;
- SARS virus history;
- For those with fever, axillary temperature ≥37.3℃ on the day of inclusion;
- A past history of severe allergy to any vaccine, or to the active ingredient of the test vaccine, any inactive ingredient, or substance used in the manufacturing process, including aluminum preparations, egg protein, neomycin, formaldehyde, tritonX-100, such as: Acute anaphylaxis, dyspnea, angioneurotic edema, etc., or allergies during previous vaccinations of the same kind;
- Patients with uncontrolled epilepsy and other serious neurological diseases (e.g., transverse myelitis, Guillain-Barre syndrome, demyelinating disease, etc.);
- Patients with acute diseases, or acute episodes of chronic diseases, or uncontrolled severe chronic diseases (such as hypertension that cannot be controlled by drugs, systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥100mmHg);
Show all 13Show fewer
- Patients at the active stage of autoimmune diseases (systemic lupus erythematosus, rheumatoid arthritis, ankylosing spondylitis, sjogren's syndrome, etc.), patients with congenital or acquired immune deficiency, HIV infection with opportunistic infection or uncontrolled malignant tumor, lymphoma and leukemia;
- No spleen, or splenic operation history;
- Received immunomodulators within 6 months, such as immunosuppressive doses of glucocorticoids (dose reference: equivalent to prednisone 20mg/ day, over a week); Or monoclonal antibodies; Or thymosin; Or interferon; However, topical use (such as ointments, eye drops, inhalants or nasal sprays) is allowed;
- Has received blood or blood-related products, including immunoglobulin (including rabies immunoglobulin and tetanus immunoglobulin), within 3 months prior to experimental vaccine vaccination; Or planned use of the experimental vaccine within 1 month of vaccination;
- If subunit vaccine and inactivated vaccine are administered within 7 days prior to experimental vaccine inoculation, live attenuated vaccine shall be administered within 14 days prior to experimental vaccine inoculation;
- Lactating women or pregnant women (including women of childbearing age with positive urine pregnancy test);
- Those who have participated in or are participating in clinical trials related to COVID-19, or are participating in clinical trials of other drugs, or have received COVID-19 vaccines; The Investigator believes that the subject has any disease or condition that may place the subject at unacceptable risk; Subjects cannot meet the requirements of the program; Conditions that interfere with the assessment of vaccine response.
Trial locations and contacts
1 site in 1 country.
China1 site
Hunan Provincial Center for Disease Control and Prevention
Changsha, Hunan, 411228
About this study
Official title: Clinical Study on Immunogenicity and Safety of Recombinant Novel Coronavirus（COVID-19）Vaccine (CHO Cell) Combined With Tetravalent Influenza Virus Lysis Vaccine in People Aged 18 Years and Over
Popular topic：Clinical study of recombinant Novel Coronavirus vaccine (CHO cell) combined with influenza vaccine. Research purpose:Main purpose:To evaluate the immunogenicity of recombinant Novel Coronavirus vaccine (CHO cells) combined with influenza vaccine in people aged 18 years and over. Secondary purpose:To evaluate the safety of recombinant Novel Coronavirus vaccine (CHO cells) combined with influenza vaccine in people aged 18 years and over. Overall design:An open experimental design was adopted in this study, and 300 subjects were planned to be enrolled. To evaluate the immunogenicity and safety of recombinant Novel Coronavirus vaccine (CHO cells) in combination with influenza vaccine. Study population:The study involved people 18 years of age and older.
Test groups:A total of 300 cases were enrolled. 240 patients in 18-59 years old group, 60 patients in ≥60 years old group. There were 150 cases in group A, 120 cases in 18-59 years old group, and 30 cases in ≥60 years old group. There were 150 cases in group B, 120 cases in 18-59 years old group and 30 cases in ≥60 years old group.
Read the detailed description
Overall design:An open experimental design was adopted in this study, and 300 subjects were planned to be enrolled. To evaluate the immunogenicity and safety of recombinant Novel Coronavirus vaccine (CHO cells) in combination with influenza vaccine.
Intervention:
Group A: one dose of influenza virus split vaccine and one dose of recombinant Novel coronavirus vaccine (CHO cells) in the contralateral arm on day 0, the second dose of recombinant Novel coronavirus vaccine (CHO cells) on day 30, and the third dose of recombinant Novel coronavirus vaccine (CHO cells) on day 60 were given intramuscularly in the upper arm deltoid muscle.
Group B: the first dose of recombinant Novel coronavirus vaccine (CHO cells) was administered on day 0, the second dose of recombinant Coronavirus vaccine (CHO cells) on day 30, the first dose of influenza virus lysate vaccine on day 44, and the third dose of recombinant Coronavirus vaccine (CHO cells) on day 60.
One dose of recombinant Novel Coronavirus vaccine (CHO cells) was administered at 0.5mL each dose, containing 25μg nCP-RBD protein. Influenza virus lysis vaccine, one dose at a time, each dose 0.5mL, containing each influenza virus strain hemagglutinin 15μg.
Immunogenicity observation:
Evaluation of immunogenicity In group A, about 5.0mL of venous blood was collected for immunogenicity test before the first dose of vaccine, before the second dose of Novel Coronavirus vaccine (CHO cells) and 14 days after the third dose of recombinant Novel Coronavirus vaccine (CHO cells).
In group B, about 5.0mL of venous blood was collected for immunogenicity test before the first dose of vaccine and 14 days after the third dose of recombinant Novel Coronavirus vaccine (CHO cells).
Safety assessment
AE and SAE
All adverse events (AE), all AE at 30 min after each dose of recombinant Novel Coronavirus vaccine (CHO cells) and influenza vaccine, all AE at 0-7 days (both solicitation and non-solicitation AE) and all AE at 8-30 days (non-solicitation AE) were collected; All SAE were collected from the first dose to 1 month after full immunization.
Solicitation AE[the following events occurring within 7 days after vaccination with recombinant Novel Coronavirus vaccine (CHO cells)] :
Inoculation site (local) AE: pain, swelling, induration, redness, rash, pruritus Vital signs: fever Non-inoculated site (whole body) AE: headache, fatigue/fatigue, diarrhea, nausea, vomiting, muscle pain (non-inoculated site), acute allergic reaction, cough
Vital signs and physical examination
All subjects shall have their axillary body temperature checked daily during the screening period, before the subsequent dose of recombinant Novel Coronavirus vaccine (CHO cells), and within 7 days after each dose of recombinant Novel Coronavirus vaccine (CHO cells); Subjects in group B will have their armpit temperature measured before influenza vaccination (the day of vaccination).
All subjects underwent physical examination (skin and cardiopulmonary auscultation) and blood pressure measurement during the screening period.
Pregnancy event
Urine pregnancy test should be performed on women of childbearing age before each dose of recombinant Novel Coronavirus vaccine (CHO cells); Women of childbearing age in group B should have a urine pregnancy test prior to influenza vaccination.
Pregnancy events occurring within 1 month from the first dose of vaccine to full immunization were collected.
ADE/VED risk monitoring
After vaccination (at least 1 dose of trial vaccine) (at each visit), subjects will be reminded to contact the investigator in case of fever and/or respiratory symptoms (e.g., dyspnea, sore throat, etc.), suspected or confirmed cases of COVID-19 occurring during the study period. If the subjects are suspected or confirmed to be infected with SARS-COV-2 during the trial period, they should go to a local designated hospital for diagnosis and treatment. A detailed case-by-case investigation is required for confirmed cases. In the event of severe COVID-19 infection or death, an expert meeting should be held to evaluate ADE/VED.
- Conditions
- Coronavirus Disease 2019
- Being tested
- Tetravalent influenza virus lysis vaccine, Recombinant new coronavirus vaccine (CHO cell) group
- Keywords
- Recombinant Novel Coronavirus Vaccine, Tetravalent influenza virus lysis 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.
Tetravalent influenza virus lysis vaccineBiological
Influenza virus lysis vaccine, one dose at a time, each dose 0.5mL, containing each influenza virus strain hemagglutinin 15μg.
Recombinant new coronavirus vaccine (CHO cell) groupBiological
One dose of recombinant Novel Coronavirus vaccine (CHO cells) was administered at 0.5mL each dose, containing 25μg nCP-RBD protein.
| Study group | Role | What they receive |
|---|---|---|
| Population Ⅰ | Experimental | One dose of influenza virus split vaccine and one dose of recombinant Novel coronavirus vaccine (CHO cells) were given in the contralateral arm on day 0, the second dose of recombinant Novel coronavirus vaccine (CHO cells) on day 30 and the third dose of recombinant Novel coronavirus vaccine (CHO cells) on day 60, all in the upper arm deltoid muscle. Receives: Biological: Tetravalent influenza virus lysis vaccine; Biological: Recombinant new coronavirus vaccine (CHO cell) group |
| Population Ⅱ | Experimental | The first dose of recombinant Novel Coronavirus vaccine (CHO cells) was given on day 0, the second dose of recombinant Coronavirus vaccine (CHO cells) on day 30, the first dose of influenza virus lysate vaccine on day 44, and the third dose of recombinant Coronavirus vaccine (CHO cells) on day 60, all in the upper arm deltoid muscle. Receives: Biological: Tetravalent influenza virus lysis vaccine; Biological: Recombinant new coronavirus vaccine (CHO cell) group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary endpoint:
Positive conversion rate of SARS-COV-2 neutralizing antibody at day 14 after full inoculation of recombinant Novel Coronavirus vaccine (CHO cells).
Measured: 14 days after vaccination
Secondary outcomes (5)
Secondary endpoint:
SARS-cov-2 neutralizing antibody GMT on day 14 after full immunization with recombinant Novel Coronavirus vaccine (CHO cells);
Measured: 14 days after vaccination
Secondary endpoint:
HI antibody GMT, positive conversion rate and serum protection rate of influenza virus typing 30 days after influenza vaccination;
Measured: 1 months after full vaccination
Secondary endpoint:
Incidence of adverse reactions/events at each time point after each dose of recombinant Novel Coronavirus vaccine (CHO cells) (at least 30 min, 0-7 days and 8-30 days after inoculation);
Measured: 1 months after full vaccination
Secondary endpoint:
Incidence of adverse reactions/events within 30 minutes of influenza vaccination;
Measured: within 30 minutes of influenza vaccination
Secondary endpoint:
Incidence of all serious adverse events (SAE) and incidence of vaccine-related SAE from the first dose of recombinant Novel Coronavirus vaccine (CHO cells) to 1 month after full vaccination.
Measured: 1 months after full vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2021
- Study start3 Sep 2021
- Primary completion4 Mar 2022
- Study completion4 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronavirus Disease 2019Studies 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
- Masking
- None (open label)
- Enrolment
- 299 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tao Huang, Principal investigator, Hunan Provincial Center for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05107375
- Sponsor's protocol ID
- IIT-LKM-2021-NCV01
- Status last verified
- Jun 2023
- First submitted
- 1 Nov 2021
- Last updated
- 8 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on Immunogenicity and Safety of Recombinant Novel Coronavirus（COVID-19）Vaccine (CHO Cell) Combined With Tetravalent Influenza Virus Lysis Vaccine in People Aged 18 Years and Over
- ClinicalTrials.gov ID
- NCT05107375
- Acronym / sponsor ID
- IIT-LKM-2021-NCV01
- Conditions
- Coronavirus Disease 2019
- Keywords
- Recombinant Novel Coronavirus Vaccine, Tetravalent influenza virus lysis vaccine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 299 participants (actual)
- Lead sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 3 Sep 2021 (actual)
- Primary completion
- 4 Mar 2022 (actual)
- Study completion
- 4 Mar 2022 (actual)
- First posted
- 4 Nov 2021 (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.
Popular topic：Clinical study of recombinant Novel Coronavirus vaccine (CHO cell) combined with influenza vaccine. Research purpose:Main purpose:To evaluate the immunogenicity of recombinant Novel Coronavirus vaccine (CHO cells) combined with influenza vaccine in people aged 18 years and over. Secondary purpose:To evaluate the safety of recombinant Novel Coronavirus vaccine (CHO cells) combined with influenza vaccine in people aged 18 years and over. Overall design:An open experimental design was adopted in this study, and 300 subjects were planned to be enrolled. To evaluate the immunogenicity and safety of recombinant Novel Coronavirus vaccine (CHO cells) in combination with influenza vaccine. Study population:The study involved people 18 years of age and older.
Test groups:A total of 300 cases were enrolled. 240 patients in 18-59 years old group, 60 patients in ≥60 years old group. There were 150 cases in group A, 120 cases in 18-59 years old group, and 30 cases in ≥60 years old group. There were 150 cases in group B, 120 cases in 18-59 years old group and 30 cases in ≥60 years old group.
Detailed description
Overall design:An open experimental design was adopted in this study, and 300 subjects were planned to be enrolled. To evaluate the immunogenicity and safety of recombinant Novel Coronavirus vaccine (CHO cells) in combination with influenza vaccine.
Intervention:
Group A: one dose of influenza virus split vaccine and one dose of recombinant Novel coronavirus vaccine (CHO cells) in the contralateral arm on day 0, the second dose of recombinant Novel coronavirus vaccine (CHO cells) on day 30, and the third dose of recombinant Novel coronavirus vaccine (CHO cells) on day 60 were given intramuscularly in the upper arm deltoid muscle.
Group B: the first dose of recombinant Novel coronavirus vaccine (CHO cells) was administered on day 0, the second dose of recombinant Coronavirus vaccine (CHO cells) on day 30, the first dose of influenza virus lysate vaccine on day 44, and the third dose of recombinant Coronavirus vaccine (CHO cells) on day 60.
One dose of recombinant Novel Coronavirus vaccine (CHO cells) was administered at 0.5mL each dose, containing 25μg nCP-RBD protein. Influenza virus lysis vaccine, one dose at a time, each dose 0.5mL, containing each influenza virus strain hemagglutinin 15μg.
Immunogenicity observation:
Evaluation of immunogenicity In group A, about 5.0mL of venous blood was collected for immunogenicity test before the first dose of vaccine, before the second dose of Novel Coronavirus vaccine (CHO cells) and 14 days after the third dose of recombinant Novel Coronavirus vaccine (CHO cells).
In group B, about 5.0mL of venous blood was collected for immunogenicity test before the first dose of vaccine and 14 days after the third dose of recombinant Novel Coronavirus vaccine (CHO cells).
Safety assessment
AE and SAE
All adverse events (AE), all AE at 30 min after each dose of recombinant Novel Coronavirus vaccine (CHO cells) and influenza vaccine, all AE at 0-7 days (both solicitation and non-solicitation AE) and all AE at 8-30 days (non-solicitation AE) were collected; All SAE were collected from the first dose to 1 month after full immunization.
Solicitation AE[the following events occurring within 7 days after vaccination with recombinant Novel Coronavirus vaccine (CHO cells)] :
Inoculation site (local) AE: pain, swelling, induration, redness, rash, pruritus Vital signs: fever Non-inoculated site (whole body) AE: headache, fatigue/fatigue, diarrhea, nausea, vomiting, muscle pain (non-inoculated site), acute allergic reaction, cough
Vital signs and physical examination
All subjects shall have their axillary body temperature checked daily during the screening period, before the subsequent dose of recombinant Novel Coronavirus vaccine (CHO cells), and within 7 days after each dose of recombinant Novel Coronavirus vaccine (CHO cells); Subjects in group B will have their armpit temperature measured before influenza vaccination (the day of vaccination).
All subjects underwent physical examination (skin and cardiopulmonary auscultation) and blood pressure measurement during the screening period.
Pregnancy event
Urine pregnancy test should be performed on women of childbearing age before each dose of recombinant Novel Coronavirus vaccine (CHO cells); Women of childbearing age in group B should have a urine pregnancy test prior to influenza vaccination.
Pregnancy events occurring within 1 month from the first dose of vaccine to full immunization were collected.
ADE/VED risk monitoring
After vaccination (at least 1 dose of trial vaccine) (at each visit), subjects will be reminded to contact the investigator in case of fever and/or respiratory symptoms (e.g., dyspnea, sore throat, etc.), suspected or confirmed cases of COVID-19 occurring during the study period. If the subjects are suspected or confirmed to be infected with SARS-COV-2 during the trial period, they should go to a local designated hospital for diagnosis and treatment. A detailed case-by-case investigation is required for confirmed cases. In the event of severe COVID-19 infection or death, an expert meeting should be held to evaluate ADE/VED.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Population Ⅰ | Experimental | Biological: Tetravalent influenza virus lysis vaccine, Biological: Recombinant new coronavirus vaccine (CHO cell) groupOne dose of influenza virus split vaccine and one dose of recombinant Novel coronavirus vaccine (CHO cells) were given in the contralateral arm on day 0, the second dose of recombinant Novel coronavirus vaccine (CHO cells) on day 30 and the third dose of recombinant Novel coronavirus vaccine (CHO cells) on day 60, all in the upper arm deltoid muscle. |
| Population Ⅱ | Experimental | Biological: Tetravalent influenza virus lysis vaccine, Biological: Recombinant new coronavirus vaccine (CHO cell) groupThe first dose of recombinant Novel Coronavirus vaccine (CHO cells) was given on day 0, the second dose of recombinant Coronavirus vaccine (CHO cells) on day 30, the first dose of influenza virus lysate vaccine on day 44, and the third dose of recombinant Coronavirus vaccine (CHO cells) on day 60, all in the upper arm deltoid muscle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy subjects aged 18 and above with full capacity for civil conduct, who can provide valid identification;
- The subjects voluntarily agree to participate in the study and sign the informed consent to understand and comply with the requirements of the study protocol;
- Fertile men and women of reproductive age did not have sex from day 1 of the last menstrual cycle to day 1 of the study, or did not have sex using effective contraceptive methods and did not experience contraceptive failure (examples of contraceptive failure include male condom rupture during sex). At the same time, subjects agreed to take effective contraceptive measures for 1 month from the signing of informed consent to the full immunization and no pregnancy plans during this period.
Key exclusion criteria (13 listed)
- History of novel coronavirus infection confirmed or asymptomatic infected persons or positive nucleic acid test of novel Coronavirus;
- SARS virus history;
- For those with fever, axillary temperature ≥37.3℃ on the day of inclusion;
- A past history of severe allergy to any vaccine, or to the active ingredient of the test vaccine, any inactive ingredient, or substance used in the manufacturing process, including aluminum preparations, egg protein, neomycin, formaldehyde, tritonX-100, such as: Acute anaphylaxis, dyspnea, angioneurotic edema, etc., or allergies during previous vaccinations of the same kind;
- Patients with uncontrolled epilepsy and other serious neurological diseases (e.g., transverse myelitis, Guillain-Barre syndrome, demyelinating disease, etc.);
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 |
|---|---|---|
| Tetravalent influenza virus lysis vaccineInfluenza virus lysis vaccine, one dose at a time, each dose 0.5mL, containing each influenza virus strain hemagglutinin 15μg. | Biological | Population Ⅰ, Population Ⅱ |
| Recombinant new coronavirus vaccine (CHO cell) groupOne dose of recombinant Novel Coronavirus vaccine (CHO cells) was administered at 0.5mL each dose, containing 25μg nCP-RBD protein. | Biological | Population Ⅰ, Population Ⅱ |
Primary outcome
Primary endpoint:
Time frame: 14 days after vaccination
Positive conversion rate of SARS-COV-2 neutralizing antibody at day 14 after full inoculation of recombinant Novel Coronavirus vaccine (CHO cells).
5 secondary outcomes
Secondary endpoint:
Time frame: 14 days after vaccination
Secondary endpoint:
Time frame: 1 months after full vaccination
Secondary endpoint:
Time frame: 1 months after full vaccination
Secondary endpoint:
Time frame: within 30 minutes of influenza vaccination
Secondary endpoint:
Time frame: 1 months after full 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 8 Jun 2023.
- Individual participant dataSharing planned: No
Related trials for Coronavirus Disease 2019
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
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.
Tao Huang principal investigator
Hunan Provincial Center for Disease Control and Prevention
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tetravalent influenza virus lysis vaccine and Recombinant new coronavirus vaccine (CHO cell) group in people with Coronavirus Disease 2019, run by Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. at 1 site in China.
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 13 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 8 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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. 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?
Primary endpoint: (time frame: 14 days after vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jun 2023.