COVID-19Phase 1/2NCT05013983
Clinical Trial of Recombinant COVID-19 Vaccine (Sf9 Cells) in Children and Adolescents
A Phase 1/2 study testing Recombinant COVID-19 vaccine (Sf9 cells) in people with COVID-19, run by WestVac Biopharma Co., Ltd. at 1 site in China.
Trial summary
This is a phase Ⅰ/Ⅱ, single-center, randomized, double-blind, placebo-controlled study, to evaluate the safety, tolerability and immunogenicity of the recombinant COVID-19 vaccine (Sf9 cells) in the subjects from healthy aged 6-17 years with immunization procedures 0, 21, 42 days and doses (10μg/20μg/40μg). Read more about this study
- Who is it for?
- Ages 6 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- Recombinant COVID-19 vaccine (Sf9 cells)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- Jul 2024to Dec 2025
- Phase
- Phase 1/2
- 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 6 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Aged 6-17 years；
- The subject and/or guardian can understand and voluntarily sign the informed consent form (double signature is required for 8-17 years old)；
- Reproductive women have a negative pregnancy test before each vaccination；
- The subjects are able and willing to comply with the requirements of the clinical trial protocol, and can complete the study follow-up for approximately 13.5 months.
Who cannot join
- History of SARS-CoV-2 infection.
- The COVID-19 antibody (IgG and IgM) screening was positive.
- History of asthma, history of allergy to vaccines or vaccine components, or severe adverse reactions to vaccines, such as urticaria, dyspnea, and angioedema.
- Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.
- Autoimmune diseases or immunodeficiency/immunosuppression.
- Severe chronic diseases that cannot be controlled by drugs, severe cardiovascular diseases, diabetes, liver and kidney diseases, malignant tumors, etc.
Show all 20Show fewer
- Severe neurological disease (epilepsy, convulsions or convulsions) or mental illness.
- Any condition caused by thyroid disease or history of thyroidectomy, hypersplenism, or splenectomy.
- Diagnosis of abnormal blood clotting function (for example, lack of clotting factors, coagulopathy, abnormal platelets) or obvious bruising or blood clotting.
- In the past 6 months, received immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids (excluding corticosteroid spray therapy for allergic rhinitis, and superficial corticosteroid therapy for acute uncomplicated dermatitis).
- Laboratory test results with clinically significant abnormalities (severity level 2 and above) (applicable to phase I clinical trials only).
- Received blood products in the last 3 months.
- Receive other study drugs or vaccines within the past 30 days.
- Vaccination against live attenuated vaccines in the past 30 days.
- Inactivated vaccine or subunit vaccine in the past 14 days.
- Acute disease or acute exacerbation of chronic disease in the last 7 days.
- Axillary temperature> 37.0°C.
- According to the judgment of the investigator, the subject has other factors that are not suitable for participating in the clinical trial.
- Subsequent dose exclusion criteria:
- In this trial, the second/third dose of vaccination may be stopped in some cases. This includes allergic reactions, severe hypersensitivity reactions, or grade 3 or higher adverse reactions that cannot be tolerated after previous vaccination/placebo. If these reactions occur, the subject should not continue to receive the second/third vaccination.
Trial locations and contacts
1 site in 1 country.
China1 site
Jiangsu Provincial Center for Diseases Control and Prevention
Nanjing, Jiangsu, 210009
About this study
Official title: Single-center, Randomized, Double-blind, Placebo-controlled Phase I/II Clinical Trial to Evaluate the Safety, Tolerability and Immunogenicity of Recombinant COVID-19 Vaccine (Sf9 Cells) in Healthy People Aged 6-17 Years
This is a phase Ⅰ/Ⅱ, single-center, randomized, double-blind, placebo-controlled study, to evaluate the safety, tolerability and immunogenicity of the recombinant COVID-19 vaccine (Sf9 cells) in the subjects from healthy aged 6-17 years with immunization procedures 0, 21, 42 days and doses (10μg/20μg/40μg).
Read the detailed description
This is a phase Ⅰ/Ⅱ, single-center, randomized, double-blind, placebo-controlled study, to evaluate the safety, tolerability and immunogenicity of the recombinant COVID-19 vaccine (Sf9 cells) in the subjects from healthy aged 6-17 years with immunization procedures 0, 21, 42 days and doses (10μg/20μg/40μg). The phase Ⅰ clinical trials designed 4 research group, including immunization procedures 0, 21 42 days , three doses (10μg/0.25ml, 20μg/0.5ml, 40μg/1.0ml) and two ages group (6-11 and 12-17years): Each group including 30 participants. Vaccination or placebo group will be randomly assigned to receive in a 2:1 ratio, 120 in total. The phase Ⅱ clinical trials designed 4 research group, including immunization procedures 0, 21 42 days , three doses (10μg/0.25ml, 20μg/0.5ml, 40μg/1.0ml) and two ages group (6-11 and 12-17years): Each group including 120 participants. Vaccination or placebo group will be randomly assigned to receive in a 2:1 ratio, 480 in total.
- Conditions
- COVID-19
- Being tested
- Recombinant COVID-19 vaccine (Sf9 cells), Placebo control
- Keywords
- Safety, Immunogenicity, COVID-19 Vaccine, Recombinant 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.
Recombinant COVID-19 vaccine (Sf9 cells)Biological
This vaccine is made by using baculovirus as a vector and expressing SARS-CoV-2 S-RBD in Sf9 cells, which is purified
Placebo controlOther
Except for the absence of study vaccine antigen, all other components (aluminum hydroxide, sodium chloride, sodium
| Study group | Role | What they receive |
|---|---|---|
| Low-dose vaccine (6-11 years) | Experimental | three doses of low-dose Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21，42. Receives: Biological: Recombinant COVID-19 vaccine (Sf9 cells) |
| Medium-dose vaccine (6-11 years) | Experimental | three doses of medium-dose Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21，42. Receives: Biological: Recombinant COVID-19 vaccine (Sf9 cells) |
| Medium-dose vaccine (12-17 years) | Experimental | three doses of medium-dose Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21，42. Receives: Biological: Recombinant COVID-19 vaccine (Sf9 cells) |
| High-dose vaccine (12-17 years) | Experimental | three doses of high-dose Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21，42. Receives: Biological: Recombinant COVID-19 vaccine (Sf9 cells) |
| Low-dose placebo (6-11 years) | Placebo comparator | three doses of low-dose placebo at the schedule of day 0, 21，42. Receives: Other: Placebo control |
| Medium-dose placebo (6-11 years) | Placebo comparator | three doses of medium-dose placebo at the schedule of day 0, 21，42. Receives: Other: Placebo control |
| Medium-dose placebo (12-17 years) | Placebo comparator | three doses of medium-dose placebo at the schedule of day 0, 21，42. Receives: Other: Placebo control |
| High-dose placebo (12-17 years) | Placebo comparator | three doses of high-dose placebo at the schedule of day 0, 21，42. Receives: Other: Placebo control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I clinical trial：The incidence of adverse reactions (ARs) .
Adverse reactions (ARs) in each dose group 0-7 days after each vaccination.
Measured: Day 0-7 days after each vaccination.
Phase II clinical trial：The incidence of adverse reactions (ARs) .
Adverse reactions (ARs) in 0-7 days after each vaccination.
Measured: Day 0-7 days after each vaccination.
Phase II clinical trial：The geometric mean titer(GMT) of specific antibody.
The geometric mean titer (GMT) of the S-RBD protein-specific IgG antibody against SARS-CoV-2.
Measured: Day 30 after completion of 3 doses vaccination
Phase II clinical trial：The geometric mean titer(GMT) of specific antibody.
The geometric mean titer (GMT) of anti-SARS-CoV-2 specific neutralizing antibody (neutralization test method for live virus and/or pseudovirus).
Measured: Day 30 after completion of 3 doses vaccination
Secondary outcomes (11)
Phase I/II clinical trial：The incidence of adverse events (AEs)
Adverse events (AEs) in 0-7 days after each vaccination.
Measured: Day 0-7 days after each vaccination.
Phase I/II clinical trial：The incidence of adverse events (AEs) in all participants.
The incidence of adverse events (AEs) from Day 0 through 30 days after completion of 3 doses vaccination in all participants.
Measured: Day 0 to 30 days after completion of 3 doses vaccination
Phase I/II clinical trial：The incidence of serious adverse events(SAEs) in all participants.
The incidence of serious adverse events(SAEs) from Day 0 through 30 days after completion of 3 doses vaccination in all participants.
Measured: Day 0 to 30 days after completion of 3 doses vaccination
Phase I/II clinical trial：The incidence of serious adverse events(SAEs) in all participants.
The incidence of serious adverse events(SAEs) from Day 0 through 12 months after completion of 3 doses vaccination in all participants.
Measured: Day 0 to 12 months after completion of 3 doses vaccination
Phase I clinical trial：Changes in laboratory test indicators
Changes in laboratory test indicators within 7 days before the first vaccination and on the 3rd day after each vaccination（Including white blood cell count, lymphocyte count, neutrophil count, platelets, hemoglobin, alanine aminotransferase ALT, aspartate aminotransferase AST, total bilirubin, fasting blood glucose, creatinine, prothrombin time, partially activated prothrombin time, urine Protein, urine red blood cells）
Measured: within 7 days before the first vaccination and on the 3rd day after each vaccination
Phase I clinical trial：The geometric mean titer (GMT) of anti-COVID-19 S-RBD protein specific antibody
The geometric mean titer (GMT) of anti-COVID-19 S-RBD protein specific antibody (ELISA method) on day 14, day 30，month 3, month 6, and month 12 after completion of 3 doses vaccination.
Measured: Day 14, Day 30，month 3, month 6, and month 12 after completion of 3 doses vaccination
Phase I clinical trial：The positive conversion rate of anti-COVID-19 S-RBD protein specific antibody.
The positive conversion rate of anti-COVID-19 S-RBD protein specific antibody (ELISA method) on day 14, day 30，month 3, month 6, and month 12 after completion of 3 doses vaccination.
Measured: Day 14, Day 30，month 3, month 6, and month 12 after completion of 3 doses vaccination
Phase I clinical trial：the geometric mean increase multiple (GMI) of anti-COVID-19 S-RBD protein specific antibody.
the geometric mean increase multiple (GMI) anti-COVID-19 S-RBD protein specific antibody (ELISA method) on day 14, day 30，month 3, month 6, and month 12 after completion of 3 doses vaccination.
Measured: Day 14, Day 30，month 3, month 6, and month 12 after completion of 3 doses vaccination
Phase I clinical trial：The geometric mean titer (GMT) / positive conversion rate/geometric mean growth multiple (GMI) of anti-COVID-19 specific neutralizing antibody
The geometric mean titer (GMT) / positive conversion rate/geometric mean growth multiple (GMI) of anti-COVID-19 specific neutralizing antibody (neutralization test method for live virus and/or pseudovirus) on day 14, day 30，month 3, month 6, and month 12 after completion of 3 doses vaccination.
Measured: Day 14, Day 30，month 3, month 6, and month 12 after completion of 3 doses vaccination
Phase II clinical trial：The positive conversion rate/geometric mean growth multiple (GMI) of anti-COVID-19 S-RBD protein specific antibody
The positive conversion rate/geometric mean growth multiple (GMI) of anti-COVID-19 S-RBD protein specific antibody on day 14, Day 30, month 6, and month 12 after completion of 3 doses vaccination
Measured: Day 14, Day 30, month 6, and month 12 after completion of 3 doses vaccination
Phase II clinical trial：The positive conversion rate/geometric mean growth multiple (GMI) of anti-COVID-19 specific neutralizing antibody
The positive conversion rate/geometric mean growth multiple (GMI) of anti-COVID-19 specific neutralizing antibody (neutralization test method for live virus and/or pseudovirus) on day 14, day 30，month 3, month 6, and month 12 after completion of 3 doses vaccination.
Measured: Day 14, Day 30, month 6, and month 12 after completion of 3 doses vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2021
- Study startJul 2024 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2025 (estimated)
Why it stopped: Clinical trials not conducted
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- WestVac Biopharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- West China Hospital
- Responsible party
- Sponsor
- Investigators
- Fengcai Zhu, Principal investigator, Jiangsu Province Centers for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05013983
- Sponsor's protocol ID
- JSVCT125
- Status last verified
- Mar 2024
- First submitted
- 17 Aug 2021
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-center, Randomized, Double-blind, Placebo-controlled Phase I/II Clinical Trial to Evaluate the Safety, Tolerability and Immunogenicity of Recombinant COVID-19 Vaccine (Sf9 Cells) in Healthy People Aged 6-17 Years
- ClinicalTrials.gov ID
- NCT05013983
- Acronym / sponsor ID
- JSVCT125
- Conditions
- COVID-19
- Keywords
- Safety, Immunogenicity, COVID-19 Vaccine, Recombinant vaccine
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Clinical trials not conducted
- Enrolment
- 0 participants (actual)
- Lead sponsor
- WestVac Biopharma Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- West China Hospital
- Study start
- Jul 2024 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 20 Aug 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.
This is a phase Ⅰ/Ⅱ, single-center, randomized, double-blind, placebo-controlled study, to evaluate the safety, tolerability and immunogenicity of the recombinant COVID-19 vaccine (Sf9 cells) in the subjects from healthy aged 6-17 years with immunization procedures 0, 21, 42 days and doses (10μg/20μg/40μg).
Detailed description
This is a phase Ⅰ/Ⅱ, single-center, randomized, double-blind, placebo-controlled study, to evaluate the safety, tolerability and immunogenicity of the recombinant COVID-19 vaccine (Sf9 cells) in the subjects from healthy aged 6-17 years with immunization procedures 0, 21, 42 days and doses (10μg/20μg/40μg). The phase Ⅰ clinical trials designed 4 research group, including immunization procedures 0, 21 42 days , three doses (10μg/0.25ml, 20μg/0.5ml, 40μg/1.0ml) and two ages group (6-11 and 12-17years): Each group including 30 participants. Vaccination or placebo group will be randomly assigned to receive in a 2:1 ratio, 120 in total. The phase Ⅱ clinical trials designed 4 research group, including immunization procedures 0, 21 42 days , three doses (10μg/0.25ml, 20μg/0.5ml, 40μg/1.0ml) and two ages group (6-11 and 12-17years): Each group including 120 participants. Vaccination or placebo group will be randomly assigned to receive in a 2:1 ratio, 480 in total.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Low-dose vaccine (6-11 years) | Experimental | Biological: Recombinant COVID-19 vaccine (Sf9 cells)three doses of low-dose Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21，42. |
| Medium-dose vaccine (6-11 years) | Experimental | Biological: Recombinant COVID-19 vaccine (Sf9 cells)three doses of medium-dose Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21，42. |
| Medium-dose vaccine (12-17 years) | Experimental | Biological: Recombinant COVID-19 vaccine (Sf9 cells)three doses of medium-dose Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21，42. |
| High-dose vaccine (12-17 years) | Experimental | Biological: Recombinant COVID-19 vaccine (Sf9 cells)three doses of high-dose Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21，42. |
| Low-dose placebo (6-11 years) | Placebo comparator | Other: Placebo controlthree doses of low-dose placebo at the schedule of day 0, 21，42. |
| Medium-dose placebo (6-11 years) | Placebo comparator | Other: Placebo controlthree doses of medium-dose placebo at the schedule of day 0, 21，42. |
| Medium-dose placebo (12-17 years) | Placebo comparator | Other: Placebo controlthree doses of medium-dose placebo at the schedule of day 0, 21，42. |
| High-dose placebo (12-17 years) | Placebo comparator | Other: Placebo controlthree doses of high-dose placebo at the schedule of day 0, 21，42. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Aged 6-17 years；
- The subject and/or guardian can understand and voluntarily sign the informed consent form (double signature is required for 8-17 years old)；
- Reproductive women have a negative pregnancy test before each vaccination；
- The subjects are able and willing to comply with the requirements of the clinical trial protocol, and can complete the study follow-up for approximately 13.5 months.
Key exclusion criteria (20 listed)
- History of SARS-CoV-2 infection.
- The COVID-19 antibody (IgG and IgM) screening was positive.
- History of asthma, history of allergy to vaccines or vaccine components, or severe adverse reactions to vaccines, such as urticaria, dyspnea, and angioedema.
- Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.
- Autoimmune diseases or immunodeficiency/immunosuppression.
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 |
|---|---|---|
| Recombinant COVID-19 vaccine (Sf9 cells)This vaccine is made by using baculovirus as a vector and expressing SARS-CoV-2 S-RBD in Sf9 cells, which is purified | Biological | High-dose vaccine (12-17 years), Low-dose vaccine (6-11 years), Medium-dose vaccine (12-17 years), Medium-dose vaccine (6-11 years) |
| Placebo controlExcept for the absence of study vaccine antigen, all other components (aluminum hydroxide, sodium chloride, sodium | Other | High-dose placebo (12-17 years), Low-dose placebo (6-11 years), Medium-dose placebo (12-17 years), Medium-dose placebo (6-11 years) |
Primary outcome
Phase I clinical trial：The incidence of adverse reactions (ARs) .
Time frame: Day 0-7 days after each vaccination.
Adverse reactions (ARs) in each dose group 0-7 days after each vaccination.
Phase II clinical trial：The incidence of adverse reactions (ARs) .
Time frame: Day 0-7 days after each vaccination.
Adverse reactions (ARs) in 0-7 days after each vaccination.
Phase II clinical trial：The geometric mean titer(GMT) of specific antibody.
Time frame: Day 30 after completion of 3 doses vaccination
The geometric mean titer (GMT) of the S-RBD protein-specific IgG antibody against SARS-CoV-2.
Phase II clinical trial：The geometric mean titer(GMT) of specific antibody.
Time frame: Day 30 after completion of 3 doses vaccination
The geometric mean titer (GMT) of anti-SARS-CoV-2 specific neutralizing antibody (neutralization test method for live virus and/or pseudovirus).
11 secondary outcomes
Phase I/II clinical trial：The incidence of adverse events (AEs)
Time frame: Day 0-7 days after each vaccination.
Phase I/II clinical trial：The incidence of adverse events (AEs) in all participants.
Time frame: Day 0 to 30 days after completion of 3 doses vaccination
Phase I/II clinical trial：The incidence of serious adverse events(SAEs) in all participants.
Time frame: Day 0 to 30 days after completion of 3 doses vaccination
Phase I/II clinical trial：The incidence of serious adverse events(SAEs) in all participants.
Time frame: Day 0 to 12 months after completion of 3 doses vaccination
Phase I clinical trial：Changes in laboratory test indicators
Time frame: within 7 days before the first vaccination and on the 3rd day after each vaccination
Phase I clinical trial：The geometric mean titer (GMT) of anti-COVID-19 S-RBD protein specific antibody
Time frame: Day 14, Day 30，month 3, month 6, and month 12 after completion of 3 doses vaccination
Phase I clinical trial：The positive conversion rate of anti-COVID-19 S-RBD protein specific antibody.
Time frame: Day 14, Day 30，month 3, month 6, and month 12 after completion of 3 doses vaccination
Phase I clinical trial：the geometric mean increase multiple (GMI) of anti-COVID-19 S-RBD protein specific antibody.
Time frame: Day 14, Day 30，month 3, month 6, and month 12 after completion of 3 doses vaccination
Phase I clinical trial：The geometric mean titer (GMT) / positive conversion rate/geometric mean growth multiple (GMI) of anti-COVID-19 specific neutralizing antibody
Time frame: Day 14, Day 30，month 3, month 6, and month 12 after completion of 3 doses vaccination
Phase II clinical trial：The positive conversion rate/geometric mean growth multiple (GMI) of anti-COVID-19 S-RBD protein specific antibody
Time frame: Day 14, Day 30, month 6, and month 12 after completion of 3 doses vaccination
Phase II clinical trial：The positive conversion rate/geometric mean growth multiple (GMI) of anti-COVID-19 specific neutralizing antibody
Time frame: Day 14, Day 30, month 6, and month 12 after completion of 3 doses vaccination
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
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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.
Fengcai Zhu principal investigator
Jiangsu Province Centers 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 1/2 study testing Recombinant COVID-19 vaccine (Sf9 cells) in people with COVID-19, run by WestVac Biopharma 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 4 inclusion and 20 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: withdrawn, as of the sponsor's last update on 28 Mar 2025. 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. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was withdrawn before enrolling participants, so there are no results.
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?
Phase I clinical trial：The incidence of adverse reactions (ARs) . (time frame: Day 0-7 days after each vaccination.). The study lists 4 primary outcomes in all. 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 28 Mar 2025.