COVID-19Phase 3NCT04904471
A Global Phase III Clinical Trial of Recombinant COVID- 19 Vaccine (Sf9 Cells)
A Phase 3 study testing Recombinant COVID-19 vaccine (Sf9 cells) in people with COVID-19, run by WestVac Biopharma Co., Ltd. at 24 sites in 5 countries.
Trial summary
This Phase III study is a global multicenter, randomized, double-blind,placebo controlled clinical trial to evaluate the efficacy, safety, and immunogenicity of therecombinant COVID-19 vaccine (Sf9 cells) in 40,000 participants aged 18 years and older who do not have a known history of SARS-CoV-2 infection but whose… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy 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
- 39,663 participants
- Where
- 24 sitesin 5 countries
- Study dates
- 15 Jun 2021to 1 Nov 2023
- 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
- Aged 18 years and older.
- Able and willing (in the investigator's opinion) to comply with all study requirements.
- Willing to allow the investigators to discuss the volunteer's medical history with their general practitioner/personal doctor and access all medical records which are relevant to study procedures.
- Healthy adults, or stable-healthy adults who may have a pre-existing medical condition that does not meet any exclusion criteria. A stable medical condition is defined as a disease not requiring significant change in therapy or hospitalization for worsening disease during the 3 months before enrollment.
- For females of childbearing potential only, willingness to practice continuous effective contraception (see glossary) for 90 days after completion of 3 doses vaccination, and have negative pregnancy tests before each dose vaccination. Note: Nonchildbearing potential is defined as surgically sterile (history of bilateral tubal ligation, bilateral oophorectomy, hysterectomy) or postmenopausal (defined as amenorrhea for ≥ 12 consecutive months prior to Screening without an alternative medical cause). A follicle-stimulating hormone (FSH) level may be measured at the discretion of the investigator to confirm postmenopausal status.
- Males participating in this study who are involved in heterosexual sexual activity must agree to practice adequate contraception (see glossary) and refrain from donating sperm for 90 days after receiving the study vaccination.
- Agreement to refrain from blood donation during the study.
- Provide a written informed consent form (ICF)
Who cannot join
- Participation in any other COVID-19 prophylactic drug trials during the duration of the study.
- Note: Participation in COVID-19 treatment trials is allowed in the event of hospitalization due to COVID-19. The study team should be informed as soon as possible.
- Positive HIV antibody testing results.
- Participation in SARS-CoV-2 serological surveys where participants are informed of their serostatus during the duration of the study.
- Note: Disclosure of serostatus post enrolment may accidentally unblind participants to group allocation. Participation in this trial can only be allowed if volunteers are kept blinded to their serology results from local/national serological surveys
- Planned receipt of any licensed or investigational vaccine, other than the study intervention,within 14 days before and after study vaccination.
Show all 21Show fewer
- Prior receipt of an investigational or licensed COVID-19 vaccine.
- Administration of immunoglobulins and/or any blood products within three months prior to the planned administration of the investigational products (IPs).
- Any confirmed or suspected immunosuppressive or immunodeficient state; positive HIV status;asplenia; recurrent severe infections and chronic use (more than 14 days) of immunosuppressant medication within the past 6 months. Topical steroids or short-term (course lasting ≤14 days) oral steroids are not exclusion criteria.
- History of allergic disease or reactions likely to be exacerbated by any component of Recombinant COVID-19 Vaccine (Sf9 cells).
- Any history of angioedema
- Pregnancy, lactation, or willingness/intention to become pregnant within 90 days after receiving study vaccine
- Current diagnosis or treatment of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ)
- History of serious psychiatric condition likely to affect participation in the study
- A bleeding disorder (e g factor deficiency coagulopathy or platelet disorder) or prior history of significant bleeding or bruising following IM injections or venipuncture
- Suspected or known current alcohol or drug dependency
- Severe and/or uncontrolled cardiovascular disease, respiratory disease, gastrointestinal disease,liver disease, renal disease, an endocrine disorder, and neurological illness (mild/moderate well-controlled comorbidities are allowed)
- History of laboratory-confirmed COVID-19
- Continuous use of anticoagulants, such as coumarins and related anticoagulants (i.e. warfarin) or novel oral anticoagulants (i.e. apixaban, rivaroxaban, dabigatran, and edoxaban)
- Any other significant disease, disorder, or finding which may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study, or impair interpretation of the study data.
- Exclusion criteria for the second/third dose In this trial, the second/third dose vaccination may be terminated in some cases. These include systemic allergic reactions, severe hypersensitivity reactions, or intolerable grade 3 or higher adverse reactions after the previous vaccination/placebo. If these reactions occur, the participants should not continue to receive the second/third vaccination.
Trial locations and contacts
24 sites in 5 countries.
24 sites in 5 countries
Philippines8 sites
Perpetual Succour Hospital - The Research Institute
Cebu City
St Luke Medical Centre - BGC
City of Taguig
De La Salle Medical and Health Sciences Institute
Dasmariñas
The Medical City - Iloilo
Iloilo City
West Visayas State University Medical Center
Iloilo City
Tropical Disease Foundation
Makati City, 1230
Makati Medical Center
Makati City
Quirino Memorial Medical Center
Quezon City, 1109
Mexico7 sites
Instituto de Investigaciones Aplicadas a la Neurociencia A.C.
Durango
Centro de Investigación Clínica y medicina traslacional (CIMeT)
Guadalajara
Hospital General Dr. Manuel Gea González
Mexico City
Invesclinic MX
Mexico City
Clínica de Enfermedades Crónicas y de Procedimientos Especiales
Morelia
SMIQ，S de R.L. de C.V.
Querétaro
FS Scientia Pharma SA de CV
San Luis Potosí City
Indonesia6 sites
Puskesmas Ciketingudik
Bekasi, Jiangsu, 210009
Permata Hospital
Bekasi
Brawijaya University Hospital
Malang
Universitas Muhammadiyah Malang Hospital
Malang
Airlangga University Hospital
Surabaya
Husada Utama Hospital
Surabaya
Kenya2 sites
Moi Teaching and Referral Hospital，Eldoret (MTRH)
Eldoret
KAVI-Institute of Clinical Research, University of Nairobi
Nairobi
About this study
Official title: A Global Multicenter, Randomized, Double-blind, Placebo-controlled, Phase III Clinical Trial to Evaluate the Efficacy, Safety, and Immunogenicity of Recombinant COVID-19 Vaccine (Sf9 Cells), for the Prevention of COVID-19 in Adults Aged 18 Years and Older
This Phase III study is a global multicenter, randomized, double-blind,placebo controlled clinical trial to evaluate the efficacy, safety, and immunogenicity of therecombinant COVID-19 vaccine (Sf9 cells) in 40,000 participants aged 18 years and older who do not have a known history of SARS-CoV-2 infection but whose locations or circumstances put them at appreciable risk of acquiring COVID-19 or SARS-CoV-2 infection.
Read the detailed description
This Phase III study is a global multicenter, randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy, safety, and immunogenicity of the recombinant COVID-19 vaccine (Sf9 cells) in 40,000 participants aged 18 years and older who do not have a known history of SARS-CoV-2 infection but whose locations or circumstances put them at appreciable risk of acquiring COVID-19 or SARS-CoV-2 infection. All participants will receive three doses of either study vaccine or placebo on Day 0, Day 21, Day 42 in a ratio of 1:1.There will be two cohorts in the study: the efficacy-safety cohort and the efficacy-extended safety-immunogenicity cohort. The efficacy will be evaluated in all vaccinated participants,including population in the efficacy-safety cohort, the efficacy-extended safety immunogenicity cohort. All vaccinated participants will also be followed up to monitor incidence of SAEs, MAAEs and AESIs. The reactogenicity of the vaccine will be evaluated in the efficacy-extended safety-immunogenicity cohort. Approximately 3000 participants will be enrolled into the efficacy-extended safety-immunogenicity cohort. This cohort will undergo additional visits to collect immunogenicity data associated with receiving the recombinant COVID-19 vaccine (Sf9 cells) and to analyze the infection status.
- Conditions
- COVID-19
- Being tested
- Recombinant COVID-19 vaccine (Sf9 cells), Placebo control
- Keywords
- SARS-CoV-2 Vaccine, Recombinant Vaccine, Efficacy, Safety, Immunnogenicity
- 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 by antigen isolation and added with aluminum hydroxide adjuvant for the prevention of COVID-19.
Placebo controlOther
Except for the absence of study vaccine antigen, all other components (aluminum hydroxide, sodium chloride, sodium dihydrogen phosphate, disodium hydrogen phosphate) are consistent with the study vaccine and have been tested and qualified by National Institutes for Food and Drug Control.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Three doses of recombinant SARS-CoV-2 vaccine (Sf9 Cell) on Day 0, Day 21and Day 42. Receives: Biological: Recombinant COVID-19 vaccine (Sf9 cells) |
| Placebo Comparator | Placebo comparator | Three doses of placebo on Day 0, Day 21and Day 42. Receives: Other: Placebo control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Virologically confirmed (polymerase chain reaction(PCR) positive) symptomatic COVID-19 cases first occurring, regardless of severity.
Virologically confirmed (PCR positive) symptomatic COVID-19 cases first occurring ﹥ 28 days after completion of 3 doses vaccination, regardless of severity.
Measured: 28 days after completion of 3 doses vaccination.
The incidence of serious adverse events(SAEs).
Serious adverse events(SAEs) from Day 0 through 6 months after completion of 3 doses vaccination.
Measured: Day 0 to 6 months after completion of 3 doses vaccination.
The incidence of adverse event of special interests(AESIs).
Adverse event of special interests(AESIs) from Day 0 through 6 months after completion of 3 doses vaccination.
Measured: Day 0 to 6 months after completion of 3 doses vaccination.
The incidence of medically attended adverse events(MAAEs).
Medically attended adverse events(MAAEs) from Day 0 through 6 months after completion of 3 doses vaccination.
Measured: Day 0 to 6 months after completion of 3 doses vaccination.
The incidence of solicited adverse events(AEs).
Solicited adverse events(AEs) within 7 days after each dose vaccination.
Measured: 0 to 7 days after each dose vaccination
The incidence of unsolicited adverse events(AEs) .
Unsolicited adverse events(AEs) within 21 days after the first dose and the second dose, and within 28 days after the third dose vaccination.
Measured: 0 to 21 days after the first dose and the second dose vaccination, and 0 to 28 days after the third dose vaccination
Secondary outcomes (16)
Virologically confirmed (polymerase chain reaction(PCR) positive) symptomatic COVID-19 cases first occurring , regardless of severity.
Virologically confirmed (polymerase chain reaction(PCR) positive) symptomatic COVID-19 cases first occurring ﹥14 days after completion of 3 doses vaccination, regardless of severity.
Measured: 14 days after completion of 3 doses vaccination.
Severe COVID-19 and death (based on WHO criteria) caused by SARS-CoV-2 infection first occurring.
Severe COVID-19 and death (based on WHO criteria) caused by SARS-CoV-2 infection first occurring ﹥ 14 days after completion of 3 doses vaccination.
Measured: 14 days after completion of 3 doses vaccination.
Severe COVID-19 and death (based on WHO criteria) caused by SARS-CoV-2 infection first occurring.
Severe COVID-19 and death (based on WHO criteria) caused by SARS-CoV-2 infection first occurring ﹥ 28 days after completion of 3 doses vaccination.
Measured: 28 days after completion of 3 doses vaccination
Virologically confirmed (polymerase chain reaction(PCR) positive) hospitalised moderate, severe COVID-19 and death caused by SARS-CoV-2 infection first occurring.
Virologically confirmed (polymerase chain reaction(PCR) positive) hospitalised moderate, severe COVID-19 and death caused by SARS-CoV-2 infection first occurring ﹥ 14 days after completion of 3 doses vaccination.
Measured: 14 days after completion of 3 doses vaccination
Virologically confirmed (polymerase chain reaction(PCR) positive) hospitalised moderate, severe COVID-19 and death caused by SARS-CoV-2 infection first occurring.
Virologically confirmed (polymerase chain reaction(PCR) positive) hospitalised moderate, severe COVID-19 and death caused by SARS-CoV-2 infection first occurring ﹥ 28 days after completion of 3 doses vaccination.
Measured: 28 days after completion of 3 doses vaccination
Serologically confirmed SARS-CoV-2 infection or virologically confirmed (polymerase chain reaction(PCR) positive) COVID-19 cases first occurring, regardless of symptomatology or severity.
Serologically confirmed SARS-CoV-2 infection or virologically confirmed (polymerase chain reaction(PCR) positive) COVID-19 cases first occurring ﹥ 14 days after completion of 3 doses vaccination, regardless of symptomatology or severity.
Measured: 14 days after completion of 3 doses vaccination
Serologically confirmed SARS-CoV-2 infection or virologically confirmed (polymerase chain reaction(PCR) positive) COVID-19 cases first occurring, regardless of symptomatology or severity.
Serologically confirmed SARS-CoV-2 infection or virologically confirmed (polymerase chain reaction(PCR) positive) COVID-19 cases first occurring ﹥ 28 days after completion of 3 doses vaccination, regardless of symptomatology or severity.
Measured: 28 days after completion of 3 doses vaccination
The incidence of serious adverse events(SAEs) in all participants.
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
The incidence of medically attended adverse events(MAAEs) in all participants.
Medically attended adverse events(MAAEs) from Day 0 through 12 months after completion of 3 doses vaccination in all participants.
Measured: Day 0 through 12 months after completion of 3 doses vaccination
The incidence of adverse event of special interests(AESIs) in all participants.
Adverse event of special interests(AESIs) from Day 0 through 12 months after completion of 3 doses vaccination in all participants.
Measured: Day 0 through 12 months after completion of 3 doses vaccination
The geometric mean increase(GMI) of specific antibody.
The geometric mean increase(GMI) of spike protein (S) receptor binding domain RBD region(S-RBD) IgG antibody on day 28, month 3, month 6 and month 12 after completion of 3 doses vaccination, measured by enzyme-linked immunosorbent assays(ELISA).
Measured: Day 28, month 3, month 6, and month 12 after completion of 3 doses vaccination
The seroconversion rate of specific antibody.
The seroconversion rate of spike protein (S) receptor binding domain RBD region(S-RBD) IgG antibody on day 28, month 3, month 6 and month 12 after completion of 3 doses vaccination, measured by enzyme-linked immunosorbent assays(ELISA).
Measured: Day 28, month 3, month 6, and month 12 after completion of 3 doses vaccination
The geometric mean titer(GMT) of specific antibody.
The geometric mean titer(GMT) of spike protein (S) receptor binding domain RBD region(S-RBD) IgG antibody on day 28, month 3, month 6 and month 12 after completion of 3 doses vaccination, measured by enzyme-linked immunosorbent assays(ELISA).
Measured: Day 28, month 3, month 6, and month 12 after completion of 3 doses vaccination
The seroconversion rate of live-virus neutralizing antibody.
The seroconversion rate of live-virus neutralizing antibody on day 28, month 3, month 6 and month 12 after completion of 3 doses vaccination.
Measured: Day 28, month 3, month 6, and month 12 after completion of 3 doses vaccination
The geometric mean titer(GMT) of live-virus neutralizing antibody.
The geometric mean titer(GMT) of live-virus neutralizing antibody on day 28, month 3, month 6 and month 12 after completion of 3 doses vaccination.
Measured: Day 28, month 3, month 6, and month 12 after completion of 3 doses vaccination
The geometric mean increase(GMI) of live-virus neutralizing antibody.
The geometric mean increase(GMI) of live-virus neutralizing antibody on day 28, month 3, month 6 and month 12 after completion of 3 doses vaccination.
Measured: Day 28, month 3, 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 posted27 May 2021
- Study start15 Jun 2021
- Primary completion31 Jan 2022
- Study completion1 Nov 2023
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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 39,663 participants (actual)
Sponsor and investigators
- Lead sponsor
- WestVac Biopharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- West China Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04904471
- Sponsor's protocol ID
- JSVCT109
- Status last verified
- Mar 2024
- First submitted
- 26 May 2021
- Last updated
- 26 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 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Global Multicenter, Randomized, Double-blind, Placebo-controlled, Phase III Clinical Trial to Evaluate the Efficacy, Safety, and Immunogenicity of Recombinant COVID-19 Vaccine (Sf9 Cells), for the Prevention of COVID-19 in Adults Aged 18 Years and Older
- ClinicalTrials.gov ID
- NCT04904471
- Acronym / sponsor ID
- JSVCT109
- Conditions
- COVID-19
- Keywords
- SARS-CoV-2 Vaccine, Recombinant Vaccine, Efficacy, Safety, Immunnogenicity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39,663 participants (actual)
- Lead sponsor
- WestVac Biopharma Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- West China Hospital
- Study start
- 15 Jun 2021 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 27 May 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 Phase III study is a global multicenter, randomized, double-blind,placebo controlled clinical trial to evaluate the efficacy, safety, and immunogenicity of therecombinant COVID-19 vaccine (Sf9 cells) in 40,000 participants aged 18 years and older who do not have a known history of SARS-CoV-2 infection but whose locations or circumstances put them at appreciable risk of acquiring COVID-19 or SARS-CoV-2 infection.
Detailed description
This Phase III study is a global multicenter, randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy, safety, and immunogenicity of the recombinant COVID-19 vaccine (Sf9 cells) in 40,000 participants aged 18 years and older who do not have a known history of SARS-CoV-2 infection but whose locations or circumstances put them at appreciable risk of acquiring COVID-19 or SARS-CoV-2 infection. All participants will receive three doses of either study vaccine or placebo on Day 0, Day 21, Day 42 in a ratio of 1:1.There will be two cohorts in the study: the efficacy-safety cohort and the efficacy-extended safety-immunogenicity cohort. The efficacy will be evaluated in all vaccinated participants,including population in the efficacy-safety cohort, the efficacy-extended safety immunogenicity cohort. All vaccinated participants will also be followed up to monitor incidence of SAEs, MAAEs and AESIs. The reactogenicity of the vaccine will be evaluated in the efficacy-extended safety-immunogenicity cohort. Approximately 3000 participants will be enrolled into the efficacy-extended safety-immunogenicity cohort. This cohort will undergo additional visits to collect immunogenicity data associated with receiving the recombinant COVID-19 vaccine (Sf9 cells) and to analyze the infection status.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Biological: Recombinant COVID-19 vaccine (Sf9 cells)Three doses of recombinant SARS-CoV-2 vaccine (Sf9 Cell) on Day 0, Day 21and Day 42. |
| Placebo Comparator | Placebo comparator | Other: Placebo controlThree doses of placebo on Day 0, Day 21and Day 42. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Aged 18 years and older.
- Able and willing (in the investigator's opinion) to comply with all study requirements.
- Willing to allow the investigators to discuss the volunteer's medical history with their general practitioner/personal doctor and access all medical records which are relevant to study procedures.
- Healthy adults, or stable-healthy adults who may have a pre-existing medical condition that does not meet any exclusion criteria. A stable medical condition is defined as a disease not requiring significant change in therapy or hospitalization for worsening disease during the 3 months before enrollment.
- For females of childbearing potential only, willingness to practice continuous effective contraception (see glossary) for 90 days after completion of 3 doses vaccination, and have negative pregnancy tests before each dose vaccination. Note: Nonchildbearing potential is defined as surgically sterile (history of bilateral tubal ligation, bilateral oophorectomy, hysterectomy) or postmenopausal (defined as amenorrhea for ≥ 12 consecutive months prior to Screening without an alternative medical cause). A follicle-stimulating hormone (FSH) level may be measured at the discretion of the investigator to confirm postmenopausal status.
Key exclusion criteria (21 listed)
- Participation in any other COVID-19 prophylactic drug trials during the duration of the study.
- Note: Participation in COVID-19 treatment trials is allowed in the event of hospitalization due to COVID-19. The study team should be informed as soon as possible.
- Positive HIV antibody testing results.
- Participation in SARS-CoV-2 serological surveys where participants are informed of their serostatus during the duration of the study.
- Note: Disclosure of serostatus post enrolment may accidentally unblind participants to group allocation. Participation in this trial can only be allowed if volunteers are kept blinded to their serology results from local/national serological surveys
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 by antigen isolation and added with aluminum hydroxide adjuvant for the prevention of COVID-19. | Biological | Experimental |
| Placebo controlExcept for the absence of study vaccine antigen, all other components (aluminum hydroxide, sodium chloride, sodium dihydrogen phosphate, disodium hydrogen phosphate) are consistent with the study vaccine and have been tested and qualified by National Institutes for Food and Drug Control. | Other | Placebo Comparator |
Primary outcome
Virologically confirmed (polymerase chain reaction(PCR) positive) symptomatic COVID-19 cases first occurring, regardless of severity.
Time frame: 28 days after completion of 3 doses vaccination.
Virologically confirmed (PCR positive) symptomatic COVID-19 cases first occurring ﹥ 28 days after completion of 3 doses vaccination, regardless of severity.
The incidence of serious adverse events(SAEs).
Time frame: Day 0 to 6 months after completion of 3 doses vaccination.
Serious adverse events(SAEs) from Day 0 through 6 months after completion of 3 doses vaccination.
The incidence of adverse event of special interests(AESIs).
Time frame: Day 0 to 6 months after completion of 3 doses vaccination.
Adverse event of special interests(AESIs) from Day 0 through 6 months after completion of 3 doses vaccination.
The incidence of medically attended adverse events(MAAEs).
Time frame: Day 0 to 6 months after completion of 3 doses vaccination.
Medically attended adverse events(MAAEs) from Day 0 through 6 months after completion of 3 doses vaccination.
The incidence of solicited adverse events(AEs).
Time frame: 0 to 7 days after each dose vaccination
Solicited adverse events(AEs) within 7 days after each dose vaccination.
The incidence of unsolicited adverse events(AEs) .
Time frame: 0 to 21 days after the first dose and the second dose vaccination, and 0 to 28 days after the third dose vaccination
Unsolicited adverse events(AEs) within 21 days after the first dose and the second dose, and within 28 days after the third dose vaccination.
16 secondary outcomes
Virologically confirmed (polymerase chain reaction(PCR) positive) symptomatic COVID-19 cases first occurring , regardless of severity.
Time frame: 14 days after completion of 3 doses vaccination.
Severe COVID-19 and death (based on WHO criteria) caused by SARS-CoV-2 infection first occurring.
Time frame: 14 days after completion of 3 doses vaccination.
Severe COVID-19 and death (based on WHO criteria) caused by SARS-CoV-2 infection first occurring.
Time frame: 28 days after completion of 3 doses vaccination
Virologically confirmed (polymerase chain reaction(PCR) positive) hospitalised moderate, severe COVID-19 and death caused by SARS-CoV-2 infection first occurring.
Time frame: 14 days after completion of 3 doses vaccination
Virologically confirmed (polymerase chain reaction(PCR) positive) hospitalised moderate, severe COVID-19 and death caused by SARS-CoV-2 infection first occurring.
Time frame: 28 days after completion of 3 doses vaccination
Serologically confirmed SARS-CoV-2 infection or virologically confirmed (polymerase chain reaction(PCR) positive) COVID-19 cases first occurring, regardless of symptomatology or severity.
Time frame: 14 days after completion of 3 doses vaccination
Serologically confirmed SARS-CoV-2 infection or virologically confirmed (polymerase chain reaction(PCR) positive) COVID-19 cases first occurring, regardless of symptomatology or severity.
Time frame: 28 days after completion of 3 doses vaccination
The incidence of serious adverse events(SAEs) in all participants.
Time frame: Day 0 to 12 months after completion of 3 doses vaccination
The incidence of medically attended adverse events(MAAEs) in all participants.
Time frame: Day 0 through 12 months after completion of 3 doses vaccination
The incidence of adverse event of special interests(AESIs) in all participants.
Time frame: Day 0 through 12 months after completion of 3 doses vaccination
The geometric mean increase(GMI) of specific antibody.
Time frame: Day 28, month 3, month 6, and month 12 after completion of 3 doses vaccination
The seroconversion rate of specific antibody.
Time frame: Day 28, month 3, month 6, and month 12 after completion of 3 doses vaccination
The geometric mean titer(GMT) of specific antibody.
Time frame: Day 28, month 3, month 6, and month 12 after completion of 3 doses vaccination
The seroconversion rate of live-virus neutralizing antibody.
Time frame: Day 28, month 3, month 6, and month 12 after completion of 3 doses vaccination
The geometric mean titer(GMT) of live-virus neutralizing antibody.
Time frame: Day 28, month 3, month 6, and month 12 after completion of 3 doses vaccination
The geometric mean increase(GMI) of live-virus neutralizing antibody.
Time frame: Day 28, month 3, month 6, and month 12 after completion of 3 doses 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 26 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.
The record lists no contact. Use the official record to reach the sponsor.
24 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Recombinant COVID-19 vaccine (Sf9 cells) in people with COVID-19, run by WestVac Biopharma Co., Ltd. at 24 sites in 5 countries.
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 8 inclusion and 21 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 26 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 24 sites in Philippines, Mexico, Indonesia, Kenya, Nepal. 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?
Virologically confirmed (polymerase chain reaction(PCR) positive) symptomatic COVID-19 cases first occurring, regardless of severity. (time frame: 28 days after completion of 3 doses vaccination.). The study lists 6 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 26 Mar 2025.