COVID-19Phase 3NCT04847102
A Phase III Clinical Study of a SARS-CoV-2 Messenger Ribonucleic Acid (mRNA) Vaccine Candidate Against COVID-19 in Population Aged 18 Years and Above
A Phase 3 study testing SARS-CoV-2 mRNA Vaccine in people with COVID-19 and SARS-CoV-2, run by Walvax Biotechnology Co., Ltd. at 12 sites in 2 countries.
Trial summary
Approximately 28,000 subjects will be enrolled in this trial. Eligible subjects will be stratified by age (<60 years of age and ≥60 years of age, the proportion of elderly people ≥60 years old is planned to be ≥25%) and randomly assigned into the study group and the control group at a ratio of 1:1 (14,000 in each… 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, SARS-CoV-2
- What is being tested?
- SARS-CoV-2 mRNA Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28,000 participants
- Where
- 12 sitesin 2 countries
- Study dates
- 22 Jul 2021to 30 May 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
- Subjects included in this trial must meet all of the following inclusion criteria:
- Adults aged 18 and above (both males and females are required);
- Individuals who are able to understand the contents listed in the informed consent form and the procedure of this clinical trial; are able to sign the informed consent form voluntarily;
- Individuals who are able to communicate well with the investigator and has the ability to understand and comply with the requirements of the clinical trial;
- Individuals who are at risk of SARS-CoV-2 infection or are exposed to COVID-19 due to regional, occupational, activity and environmental factors;
- For female participants of childbearing potential, effective contraception should be used within 2 weeks prior to participation in this study and the pregnancy test results is required to be negative (those with amenorrhea of at least 1 year or surgical sterilization verified by medical records could be exempted from the pregnancy test). Participants should voluntarily agree to continue using at least one effective methods of contraception for 12 months after complete series (effective methods include oral contraceptives, injectable or implantable contraceptives, sustained-release topical contraceptives, hormonal patches, intrauterine device, sterilization, abstinence, condoms (for males), diaphragms, cervical caps, etc.).
- Healthy individuals with verified medical history: individuals who are in a stable condition and whose current diseases will not worsen for at least 3 months prior to enrollment to this study.
Who cannot join
- Subjects who meet any of the following exclusion criteria shall not be enrolled:
- Individuals with a history of SARS-CoV-2 infection or use of any preventive products for COVID-19 (e.g., a history of any SARS-CoV-2 vaccines that have or have not been marketed);
- Individuals with SARS-CoV-2 etiological testing (RT-PCR Assay) (individuals with serological testing showing positive IgG and/or IgM antibodies may be enrolled);
- Individuals with a previous history of severe acute respiratory syndrome (SARS), middle east respiratory syndrome (MERS) and other human coronavirus infections or diseases;
- Individuals who have fever within 72 hours prior to Dose 1 in this trial (oral temperature ≥38°C);
- Pregnant (e.g., positive pregnancy test) or lactating females;
Show all 33Show fewer
- Individuals who have plan of pregnancy or interruption of effective contraceptive methods within 3 months after the second cross-vaccination in this study;
- Personnel of the study site or the sponsor;
- Individuals with prior history of allergic reaction or anaphylaxis to any vaccine or drug, e.g., hypersensitivity, urticaria, serious eczema, dyspnea, laryngeal edema, and angioedema etc.;
- Individuals who have been vaccinated with any vaccine other than the investigational vaccine used in this clinical trial from 28 days prior to Dose 1 to 28 days after Dose 2;
- Individuals who have participated in or plan to participate in other drug clinical trials form 28 days prior to Dose 1 to 12 months after Dose 4 (the second dose of cross-vaccination) in this study;
- Individuals who have hereditary hemorrhagic tendency or coagulation dysfunction (e.g., cytokine defects, coagulation disorders or platelet disorder), or a history of significant bleeding, or a history of injury caused by intramuscular injection or venipuncture;
- Individuals who are confirmed for diseases affecting immune system function, including cancer (except skin basal cell carcinoma), congenital or acquired immunodeficiency (e.g., infection with human immunodeficiency virus (HIV)), and uncontrolled autoimmune disease, based on known history or diagnosis;
- Individuals who have asplenia or functional asplenia;
- Individuals with long-term use (continuous use ≥14 days) of immunosuppressants or other immunomodulatory drugs (e.g., corticosteroids: prednisone or similar drugs) within 6 months prior to Dose 1. Drugs for topical use (e.g., ointment, eye drops, inhalants or nasal spray) are allowed in this study, and the topical medications should not exceed the recommended dose in the labels for use or induce any signs of systemic exposure;
- Individuals who have received immunoglobulin and/or blood products within 3 months prior to Dose 1;
- Individuals who are suspected or known to have alcohol dependency problems or drug abuse that may affect safety evaluation or subject's compliance;
- Individuals who plan to permanently relocate from the local area before the completion of the study or leave the local area for long periods during the study visits;
- Other circumstances considered by the investigator as inappropriate to participate in the study.
- Criteria for Postponement of the Subsequent Doses:
- If the subjects have any of the followings prior to the subsequent doses, vaccination will be postponed. During the same immunization schedule, the second dose of vaccine will be administered at the 28th day after the first vaccination, with a time window of +5 days:
- Fever within 72 hours prior to the subsequent doses (oral temperature ≥38°C, probability of SARS-CoV-2 infection shall be excluded);
- In case of acute diseases prior to the subsequent doses, the investigator shall exclude the probability of SARS-CoV-2 infection and evaluate the likelihood of short-term recovery for the diseases;
- If the subject has any of the followings prior to the subsequent doses, the vaccination shall be terminated for the subject while other study procedures could be continued at the discretion of the investigators:
- Female subjects of childbearing potential who have positive pregnancy test results;
- Subjects who have a serious allergic reaction or serious adverse event causally related to vaccination after previous vaccination;
- Other circumstances considered by the investigator as inappropriate to receive the subsequent doses of the vaccine.
- Criteria for Withdrawal from the Study
- Subjects experience disability, life-threatening adverse events or serious adverse events and have to prematurely withdraw from this study due to treatment or other reasons.
- Subjects are placed at safety risks by their health conditions which prevent them from continuing to participate in this study.
- Female subjects become pregnant during the study (if at least one dose has been administered, the subject is not required to withdraw from this study but should not receive the subsequent doses. Moreover, subsequent observation and follow-up visits should be continued);
- Subjects actively request to withdraw from the study;
- Subjects are considered unsuitable for continuing to participate in this study at the discretion of the investigator.
Trial locations and contacts
12 sites in 2 countries.
12 sites in 2 countries
Mexico7 sites, 7 recruiting
- Recruiting
Centro de Investigación Clínica del Pacifico S.A. de C.V. (CICPA)
Acapulco
Rafael A Rivero, Dr.
- Recruiting
Centro de Investigación y Avances Médicos Especializados (CIAME)
Cancún
Alejandro JM Carvajal, Dr.
- Recruiting
Centro de Especialidades Médicas Aplicadas
Mexico City
José A Vázquez, Dr.
- Recruiting
Instituto Nacional de Pediatría (INP)
Mexico City
Miguel Ángel Rodríguez Weber, Dr.
- Recruiting
Oaxaca site management organization (OSMO)
Oaxaca City
Andrea AC Dominguez, Dra.
- Recruiting
Asociación Mexicana para la investigación clínica, A.C. (AMIC)
Pachuca
Joselito H Pichardo, Dr.
- Recruiting
Oncológico Potosino
San Luis Potosí City
Arturo O Alvarez, Dr.
Indonesia5 sites, 5 recruiting
- Recruiting
Persahabatan Hospital
Jakarta
Erlina Burhan, Dr.
- Recruiting
Puskesmas Duren Sawit
Jakarta
Dina Wijayanti, Dr.
- Recruiting
Puskesmas Kalideres
Jakarta
Linda Lidya
- Recruiting
Puskesmas Kebayoran Lama
Jakarta
Julianna R Amaliah, Dr.
- Recruiting
Puskesmas Pulogadung
Jakarta
Titta G Salim
About this study
Official title: A Global, Multi-center, Randomized, Double-Blind, Placebo-controlled, Phase III Clinical Study to Evaluate the Protective Efficacy, Safety and Immunogenicity of SARS-CoV-2 Messenger Ribonucleic Acid (mRNA) Vaccine in Population Aged 18 Years and Older
Approximately 28,000 subjects will be enrolled in this trial. Eligible subjects will be stratified by age (<60 years of age and ≥60 years of age, the proportion of elderly people ≥60 years old is planned to be ≥25%) and randomly assigned into the study group and the control group at a ratio of 1:1 (14,000 in each group) to be intramuscularly administered with the investigational vaccine or placebo in a 2-dose regimen at an interval of 28 days. The experimental vaccines will be cross-vaccinated after available data of the investigational vaccine show that expected efficacy and good safety have been achieved (i.e., subjects in the study group will be vaccinated with placebo and those in the control group will be vaccinated with the investigational vaccine in the same schedule as stated above ). After the completion of the second dose for crossover vaccination, subjects will be followed up for 12 months for safety observation. An immunogenicity subgroup (n≥3000) and a reactogenicity subgroup (n≥6000) will also be included in this trial to evaluate the humoral immunity induced by the investigational vaccine and the solicited adverse events observed within 7 days post immunization. All enrolled subjects will be followed up for the evaluation of protective efficacy as well, which will be primarily characterized by the incidence rate (person-year) of COVID-19 cases collected from 14 days after complete series. Adverse events will be collected over 0-28 days after each vaccination and serious adverse events will be collected from Dose 1 through 12 months post complete series.
- Conditions
- COVID-19, SARS-CoV-2
- Being tested
- SARS-CoV-2 mRNA Vaccine, Placebo
- Keywords
- SARS-CoV-2 mRNA vaccine, Efficacy, Safety, Immunogenicity
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SARS-CoV-2 mRNA VaccineBiological
The SARS-CoV-2 mRNA Vaccine is formulated by encapsulating the mRNA, which encodes the receptor-binding domain (RBD) of spike glycoprotein (S protein) of SARS-CoV-2 and is transcribed in-vitro by the corresponding DNA template, in lipid nanoparticles (LNPs). This vaccine is presented as a white to off-white dispersion for injection.
Active substances: mRNA encoding the RBD of the S protein of SARS-CoV-2.
The vaccine is supplied in single-dose pre-filled syringe with 0.5 mL dispersion for intramuscular injection. Each dose (0.5 mL) of the vaccine contains:
15 μg of mRNA encoding the RBD of the spike glycoprotein (S protein) of SARS-CoV-2, 0.339 mg of total lipids (including lipid 9001, cholesterol, DSPC, DMG-PEG2000).
PlaceboBiological
0.9% sodium chloride solution, 0.5 mL/vial
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Not described Receives: Biological: SARS-CoV-2 mRNA Vaccine; Biological: Placebo |
| Control group | Placebo comparator | Not described Receives: Biological: SARS-CoV-2 mRNA Vaccine; Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary efficacy endpoint as measured by the incidence rate (person-year) of COVID-19 cases
The incidence rate (person-year) of COVID-19 cases collected from 14 days after complete series in subjects aged 18 years and above.
Measured: From 14 days after complete series
Primary safety endpoint as measured by the incidence rates of adverse events
Incidence rates of adverse events observed for all subjects within 28 days post each vaccination;
Measured: Within 28 days post each vaccination
Primary safety endpoint as measured by the incidence rates of serious adverse events
Incidence rates of solicited adverse events observed for subjects included in the reactogenicity subgroup within 30 minutes and at 7 days post each vaccination.
Measured: At 7 days post each vaccination
Secondary outcomes (4)
Secondary efficacy endpoint as measured by the incidence rate (person-year) of severe and critical COVID-19 cases
The incidence rate (person-year) of severe and critical COVID-19 cases collected from 14 days after complete series in subjects aged 18 years and above;
Measured: From 14 days after complete series
Secondary efficacy endpoint as measured by the incidence rate (person-year) of COVID-19 cases resulting in deaths
The incidence rate (person-year) of COVID-19 cases resulting in deaths collected from 14 days after complete series in subjects aged 18 years and above;
Measured: From 14 days after complete series
Secondary efficacy endpoint as measured by the incidence rate (person-year) of COVID-19 cases post 1 dose of vaccination
The incidence rate (person-year) of COVID-19 cases collected from 14 days collected after Dose 1 in subjects aged 18 years and above who fail to be administered with Dose 2 for personal reasons.
Measured: From 14 days after Dose 1
Secondary safety endpoint as measured by the incidence rate of serious adverse events
Incidence rates of serious adverse events observed for all subjects from Dose 1 through 12 months after complete series.
Measured: From Dose 1 through 12 months after complete series
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2021
- Study start22 Jul 2021
- Primary completion30 Nov 2021 (estimated)
- Study completion30 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 28,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Walvax Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Abogen Biosciences Co. Ltd., Yuxi Walvax Biotechnology Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04847102
- Sponsor's protocol ID
- ARCoV-005
- Status last verified
- Nov 2021
- First submitted
- 13 Apr 2021
- Last updated
- 18 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Liu X, Li Y, Wang Z, Cao S, Huang W, Yuan L, Huang YJ, Zheng Y, Chen J, Ying B, Xiang Z, Shi J, Zhao J, Huang Z, Qin CF. Safety and superior immunogenicity of heterologous boosting with an RBD-based SARS-CoV-2 mRNA vaccine in Chinese adults. Cell Res. 2022 Aug;32(8):777-780. doi: 10.1038/s41422-022-00681-3. Epub 2022 Jun 14. No abstract available.
PubMed 35701541Zhang NN, Zhang RR, Zhang YF, Ji K, Xiong XC, Qin QS, Gao P, Lu XS, Zhou HY, Song HF, Ying B, Qin CF. Rapid development of an updated mRNA vaccine against the SARS-CoV-2 Omicron variant. Cell Res. 2022 Apr;32(4):401-403. doi: 10.1038/s41422-022-00626-w. Epub 2022 Feb 14. No abstract available.
PubMed 35165421
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Global, Multi-center, Randomized, Double-Blind, Placebo-controlled, Phase III Clinical Study to Evaluate the Protective Efficacy, Safety and Immunogenicity of SARS-CoV-2 Messenger Ribonucleic Acid (mRNA) Vaccine in Population Aged 18 Years and Older
- ClinicalTrials.gov ID
- NCT04847102
- Acronym / sponsor ID
- ARCoV-005
- Conditions
- COVID-19, SARS-CoV-2
- Keywords
- SARS-CoV-2 mRNA vaccine, Efficacy, Safety, Immunogenicity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28,000 participants (estimated)
- Lead sponsor
- Walvax Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Abogen Biosciences Co. Ltd., Yuxi Walvax Biotechnology Co., Ltd.
- Study start
- 22 Jul 2021 (actual)
- Primary completion
- 30 Nov 2021 (estimated)
- Study completion
- 30 May 2023 (estimated)
- First posted
- 15 Apr 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.
Approximately 28,000 subjects will be enrolled in this trial. Eligible subjects will be stratified by age (<60 years of age and ≥60 years of age, the proportion of elderly people ≥60 years old is planned to be ≥25%) and randomly assigned into the study group and the control group at a ratio of 1:1 (14,000 in each group) to be intramuscularly administered with the investigational vaccine or placebo in a 2-dose regimen at an interval of 28 days. The experimental vaccines will be cross-vaccinated after available data of the investigational vaccine show that expected efficacy and good safety have been achieved (i.e., subjects in the study group will be vaccinated with placebo and those in the control group will be vaccinated with the investigational vaccine in the same schedule as stated above ). After the completion of the second dose for crossover vaccination, subjects will be followed up for 12 months for safety observation. An immunogenicity subgroup (n≥3000) and a reactogenicity subgroup (n≥6000) will also be included in this trial to evaluate the humoral immunity induced by the investigational vaccine and the solicited adverse events observed within 7 days post immunization. All enrolled subjects will be followed up for the evaluation of protective efficacy as well, which will be primarily characterized by the incidence rate (person-year) of COVID-19 cases collected from 14 days after complete series. Adverse events will be collected over 0-28 days after each vaccination and serious adverse events will be collected from Dose 1 through 12 months post complete series.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Biological: SARS-CoV-2 mRNA Vaccine, Biological: Placebo |
| Control group | Placebo comparator | Biological: SARS-CoV-2 mRNA Vaccine, Biological: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adults aged 18 and above (both males and females are required);
- Individuals who are able to understand the contents listed in the informed consent form and the procedure of this clinical trial; are able to sign the informed consent form voluntarily;
- Individuals who are able to communicate well with the investigator and has the ability to understand and comply with the requirements of the clinical trial;
- Individuals who are at risk of SARS-CoV-2 infection or are exposed to COVID-19 due to regional, occupational, activity and environmental factors;
- For female participants of childbearing potential, effective contraception should be used within 2 weeks prior to participation in this study and the pregnancy test results is required to be negative (those with amenorrhea of at least 1 year or surgical sterilization verified by medical records could be exempted from the pregnancy test). Participants should voluntarily agree to continue using at least one effective methods of contraception for 12 months after complete series (effective methods include oral contraceptives, injectable or implantable contraceptives, sustained-release topical contraceptives, hormonal patches, intrauterine device, sterilization, abstinence, condoms (for males), diaphragms, cervical caps, etc.).
Key exclusion criteria (33 listed)
- Individuals with a history of SARS-CoV-2 infection or use of any preventive products for COVID-19 (e.g., a history of any SARS-CoV-2 vaccines that have or have not been marketed);
- Individuals with SARS-CoV-2 etiological testing (RT-PCR Assay) (individuals with serological testing showing positive IgG and/or IgM antibodies may be enrolled);
- Individuals with a previous history of severe acute respiratory syndrome (SARS), middle east respiratory syndrome (MERS) and other human coronavirus infections or diseases;
- Individuals who have fever within 72 hours prior to Dose 1 in this trial (oral temperature ≥38°C);
- Pregnant (e.g., positive pregnancy test) or lactating females;
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 |
|---|---|---|
| SARS-CoV-2 mRNA VaccineThe SARS-CoV-2 mRNA Vaccine is formulated by encapsulating the mRNA, which encodes the receptor-binding domain (RBD) of spike glycoprotein (S protein) of SARS-CoV-2 and is transcribed in-vitro by the corresponding DNA template, in lipid nanoparticles (LNPs). This vaccine is presented as a white to off-white dispersion for injection. Active substances: mRNA encoding the RBD of the S protein of SARS-CoV-2. The vaccine is supplied in single-dose pre-filled syringe with 0.5 mL dispersion for intramuscular injection. Each dose (0.5 mL) of the vaccine contains: 15 μg of mRNA encoding the RBD of the spike glycoprotein (S protein) of SARS-CoV-2, 0.339 mg of total lipids (including lipid 9001, cholesterol, DSPC, DMG-PEG2000). | Biological | Control group, Study group |
| Placebo0.9% sodium chloride solution, 0.5 mL/vial | Biological | Control group, Study group |
Primary outcome
Primary efficacy endpoint as measured by the incidence rate (person-year) of COVID-19 cases
Time frame: From 14 days after complete series
The incidence rate (person-year) of COVID-19 cases collected from 14 days after complete series in subjects aged 18 years and above.
Primary safety endpoint as measured by the incidence rates of adverse events
Time frame: Within 28 days post each vaccination
Incidence rates of adverse events observed for all subjects within 28 days post each vaccination;
Primary safety endpoint as measured by the incidence rates of serious adverse events
Time frame: At 7 days post each vaccination
Incidence rates of solicited adverse events observed for subjects included in the reactogenicity subgroup within 30 minutes and at 7 days post each vaccination.
4 secondary outcomes
Secondary efficacy endpoint as measured by the incidence rate (person-year) of severe and critical COVID-19 cases
Time frame: From 14 days after complete series
Secondary efficacy endpoint as measured by the incidence rate (person-year) of COVID-19 cases resulting in deaths
Time frame: From 14 days after complete series
Secondary efficacy endpoint as measured by the incidence rate (person-year) of COVID-19 cases post 1 dose of vaccination
Time frame: From 14 days after Dose 1
Secondary safety endpoint as measured by the incidence rate of serious adverse events
Time frame: From Dose 1 through 12 months after complete series
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2021.
- Derived from this study: PubMed 35701541Liu X, Li Y, Wang Z, Cao S, Huang W, Yuan L, Huang YJ, Zheng Y, Chen J, Ying B, Xiang Z, Shi J, Zhao J, Huang Z, Qin CF. Safety and superior immunogenicity of heterologous boosting with an RBD-based SARS-CoV-2 mRNA vaccine in Chinese adults. Cell Res. 2022 Aug;32(8):777-780. doi: 10.1038/s41422-022-00681-3. Epub 2022 Jun 14. No abstract available.
- Derived from this study: PubMed 35165421Zhang NN, Zhang RR, Zhang YF, Ji K, Xiong XC, Qin QS, Gao P, Lu XS, Zhou HY, Song HF, Ying B, Qin CF. Rapid development of an updated mRNA vaccine against the SARS-CoV-2 Omicron variant. Cell Res. 2022 Apr;32(4):401-403. doi: 10.1038/s41422-022-00626-w. Epub 2022 Feb 14. No abstract available.
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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.
12 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SARS-CoV-2 mRNA Vaccine in people with COVID-19 and SARS-CoV-2, run by Walvax Biotechnology Co., Ltd. at 12 sites in 2 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 7 inclusion and 33 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: status not confirmed, as of the sponsor's last update on 18 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Mexico, Indonesia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shuyuan Yang (+86 18687832269, ynwsysy@walvax.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary efficacy endpoint as measured by the incidence rate (person-year) of COVID-19 cases (time frame: From 14 days after complete series). The study lists 3 primary outcomes in all. 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 NCT04847102, which also lists 2 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 18 Nov 2021.