COVID-19Phase 3NCT04852705
A Study to Evaluate the Efficacy, Safety and Immunogenicity of SARS-CoV-2 Vaccine (Vero Cells), Inactivated in Healthy Adults Aged 18 Years and Older (COVID-19)
A Phase 3 study testing SARS-CoV-2 Vaccine (Vero Cells), Inactivated in people with COVID-19, run by Shenzhen Kangtai Biological Products Co., LTD.
Trial summary
The study will be a multi-national, endpoint-driven, randomized, double-blind, placebo-controlled, adaptive study in which participating adults will be randomized 1:1 to receive 2 doses of either candidate vaccine or placebo on Day 0 and 28. 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?
- SARS-CoV-2 Vaccine (Vero Cells), Inactivated
- 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
- No sites listed yet
- Study dates
- May 2021to Nov 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 residents ≥ 18 years at the time of consent, be voluntary and capable of signing the informed consent forms.
- Be able to understand and comply with study requirements/ procedures.
- Participants with negative results of SARS-CoV-2 Realtime-PCR (RT-PCR) detection.
- For females or sex-partners of males at childbearing age: be willing to use birth control for 3 months after the 2nd dose.
- For females of childbearing potential (Pausimenia ≤ 2 years ) must: have a negative urine or blood pregnancy test at screening
- Axillary temperature < 37.3℃/99.1℉ when screening (Subsequent measurements of temperature should be performed at the same site per participant; temperature measured by other methods should be converted to axillary temperature ).
Who cannot join
- Previous treatments for curing or preventing COVID-19 (including vaccination of various COVID-19 vaccines).
- History of Severe Acute Respiratory Syndrome (SARS), Middle East Respiratory Syndrome (MERS) or other coronavirus infections.
- History of allergy to any components of the candidate vaccine or severe allergic reactions to vaccine or medicine (including, but not limited to, allergic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, or local allergic necrosis (Arthus reaction)).
- Positive for HIV detection.
- History or family history of convulsion, epilepsy, encephalopathy, and psychosis.
- Active stage of malignancies, malignancies without adequate treatments, malignancies with potential risk for recurrence during the study.
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- Severe or uncontrolled cardiovascular, neurological, blood and lymphatic, kidney, liver, respiratory, metabolic and skeletal diseases.
- Congenital or functional absence of spleen, complete or partial removal of spleen in any case.
- Chronic administration (defined as ≥ 14 days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the 1st vaccination (eg. corticosteroids, ≥ 0.5 mg/kg/day prednisone or equivalent; but, inhaled and topical steroids are allowed).
- Planned administration/administration of a vaccine not foreseen by the study protocol less than 7 days before 1st dose of candidate vaccine for inactivated vaccines or 14 days before 1st dose of candidate vaccine for attenuated live vaccines.
- Receipt of blood products and/or immunoglobulins within 3 months prior to enrollment or expected receipt during the study.
- Donate or loss ≥ 450 ml of blood within 1 month prior to enrollment, or expected blood donation during the study.
- Fever: axillary temperature ≥ 37.3℃/99.1℉ within the past 24 hours (Subsequent measurements of temperature should be performed at the same site per participant; temperature measured by other methods should be converted to axillary temperature ).
- Those who participated in other clinical trials 1 month prior to the enrollment or used any investigational or non-registered drug during the study period; Those who are unable to finish follow-up or fail in efficacy assessments.
- Breastfeeding females should not be included.
- Ineligible for the study based on the assessment of investigator.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Multi-national, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of SARS-CoV-2 Vaccine (Vero Cells), Inactivated for the Prevention of COVID-19 in Healthy Adults Aged 18 Years and Older
The study will be a multi-national, endpoint-driven, randomized, double-blind, placebo-controlled, adaptive study in which participating adults will be randomized 1:1 to receive 2 doses of either candidate vaccine or placebo on Day 0 and 28. A total of 28,000 healthy adults aged 18 years and older will be enrolled and followed for efficacy, safety, and immunogenicity evaluations.
- Conditions
- COVID-19
- Being tested
- SARS-CoV-2 Vaccine (Vero Cells), Inactivated, Placebo
- 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 Vaccine (Vero Cells), InactivatedBiological
2 doses of SARS-CoV-2 Vaccine (Vero Cells), Inactivated should be administered as an intramuscular injection into the lateral deltoid of the upper arm with a 28-day interval.
PlaceboBiological
2 doses of Placebo should be administered as an intramuscular injection into the lateral deltoid of the upper arm with a 28-day interval.
| Study group | Role | What they receive |
|---|---|---|
| candidate vaccine | Experimental | Not described Receives: Biological: SARS-CoV-2 Vaccine (Vero Cells), Inactivated |
| Placebo | Placebo comparator | Not described Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence density of symptomatic COVID-19 cases
Incidence density of symptomatic COVID-19 cases occurring from 14 days after full vaccination.
Measured: 14 days after full vaccination
Secondary outcomes (15)
Incidence density of COVID-19 moderate cases and above
Incidence density of COVID-19 moderate cases and above occurring from 14 days after full vaccination.
Measured: 14 days after full vaccination
Incidence density of COVID-19 severe cases and above
Incidence density of COVID-19 severe cases and above occurring from 14 days after full vaccination.
Measured: 14 days after full vaccination
Incidence density of COVID-19 death cases and above
Incidence density of COVID-19 death cases and above occurring from 14 days after full vaccination.
Measured: 14 days after full vaccination
Incidence density of symptomatic COVID-19 cases in different age groups
Incidence density of symptomatic COVID-19 cases occurring from 14 days after full vaccination in different age groups (18~59 years and ≥ 60 years).
Measured: 14 days after full vaccination
Incidence of solicited local adverse events
Incidence of solicited local adverse events occurring 0-7 days after each vaccination.
Measured: 0-7 days after each vaccination
Incidence of solicited general adverse events
Incidence of solicited general adverse events occurring 0-7 days after each vaccination.
Measured: 0-7 days after each vaccination
Incidence of unsolicited adverse events
Incidence of unsolicited adverse events occurring 0-28 days after each vaccination.
Measured: 0-28 days after each vaccination
Incidence of SAE
Incidence of SAE occurring from the 1st dose through the end of study.
Measured: from the 1st dose through the end of study
Incidence of AESI
Incidence of AESI occurring from the 1st dose through the end of study.
Measured: from the 1st dose through the end of study
Seroconversion rate of SARS-CoV-2 neutralizing antibody
Seroconversion rate of SARS-CoV-2 neutralizing antibody in the immunogenicity subgroup
Measured: 28 days, 90 days, 180 days and 360 days after full vaccination
Geometric mean titer of SARS-CoV-2 neutralizing antibody
geometric mean titer of SARS-CoV-2 neutralizing antibody in the immunogenicity subgroup
Measured: 28 days, 90 days, 180 days and 360 days after full vaccination
Geometric mean fold increase of SARS-CoV-2 neutralizing antibody
Geometric mean fold increase of SARS-CoV-2 neutralizing antibody in the immunogenicity subgroup
Measured: 28 days, 90 days, 180 days and 360 days after full vaccination
Seroconversion rate of SARS-CoV-2 IgG binding antibody
Seroconversion rate of SARS-CoV-2 IgG binding antibody in the immunogenicity subgroup
Measured: 28 days, 90 days, 180 days and 360 days after full vaccination
Geometric mean titer of SARS-CoV-2 IgG binding antibody
Geometric mean titer of SARS-CoV-2 IgG binding antibody in the immunogenicity subgroup
Measured: 28 days, 90 days, 180 days and 360 days after full vaccination
Geometric mean fold increase of SARS-CoV-2 IgG binding antibody
Geometric mean fold increase of SARS-CoV-2 IgG binding antibody in the immunogenicity subgroup
Measured: 28 days, 90 days, 180 days and 360 days 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 posted21 Apr 2021
- Study startMay 2021 (estimated)
- Primary completionNov 2021 (estimated)
- Study completionNov 2022 (estimated)
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 28,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Kangtai Biological Products Co., LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Beijing Minhai Biotechnology Co., Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04852705
- Sponsor's protocol ID
- 2021L001
- Status last verified
- Apr 2021
- First submitted
- 20 Apr 2021
- Last updated
- 22 Apr 2021
- 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 22 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-national, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of SARS-CoV-2 Vaccine (Vero Cells), Inactivated for the Prevention of COVID-19 in Healthy Adults Aged 18 Years and Older
- ClinicalTrials.gov ID
- NCT04852705
- Acronym / sponsor ID
- 2021L001
- Conditions
- COVID-19
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28,000 participants (estimated)
- Lead sponsor
- Shenzhen Kangtai Biological Products Co., LTDIndustry (pharma, biotech, devices)
- Collaborators
- Beijing Minhai Biotechnology Co., Ltd
- Study start
- May 2021 (estimated)
- Primary completion
- Nov 2021 (estimated)
- Study completion
- Nov 2022 (estimated)
- First posted
- 21 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.
The study will be a multi-national, endpoint-driven, randomized, double-blind, placebo-controlled, adaptive study in which participating adults will be randomized 1:1 to receive 2 doses of either candidate vaccine or placebo on Day 0 and 28. A total of 28,000 healthy adults aged 18 years and older will be enrolled and followed for efficacy, safety, and immunogenicity evaluations.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| candidate vaccine | Experimental | Biological: SARS-CoV-2 Vaccine (Vero Cells), Inactivated |
| Placebo | Placebo comparator | Biological: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Healthy residents ≥ 18 years at the time of consent, be voluntary and capable of signing the informed consent forms.
- Be able to understand and comply with study requirements/ procedures.
- Participants with negative results of SARS-CoV-2 Realtime-PCR (RT-PCR) detection.
- For females or sex-partners of males at childbearing age: be willing to use birth control for 3 months after the 2nd dose.
- For females of childbearing potential (Pausimenia ≤ 2 years ) must: have a negative urine or blood pregnancy test at screening
Key exclusion criteria (16 listed)
- Previous treatments for curing or preventing COVID-19 (including vaccination of various COVID-19 vaccines).
- History of Severe Acute Respiratory Syndrome (SARS), Middle East Respiratory Syndrome (MERS) or other coronavirus infections.
- History of allergy to any components of the candidate vaccine or severe allergic reactions to vaccine or medicine (including, but not limited to, allergic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, or local allergic necrosis (Arthus reaction)).
- Positive for HIV detection.
- History or family history of convulsion, epilepsy, encephalopathy, and psychosis.
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 Vaccine (Vero Cells), Inactivated2 doses of SARS-CoV-2 Vaccine (Vero Cells), Inactivated should be administered as an intramuscular injection into the lateral deltoid of the upper arm with a 28-day interval. | Biological | candidate vaccine |
| Placebo2 doses of Placebo should be administered as an intramuscular injection into the lateral deltoid of the upper arm with a 28-day interval. | Biological | Placebo |
Primary outcome
Incidence density of symptomatic COVID-19 cases
Time frame: 14 days after full vaccination
Incidence density of symptomatic COVID-19 cases occurring from 14 days after full vaccination.
15 secondary outcomes
Incidence density of COVID-19 moderate cases and above
Time frame: 14 days after full vaccination
Incidence density of COVID-19 severe cases and above
Time frame: 14 days after full vaccination
Incidence density of COVID-19 death cases and above
Time frame: 14 days after full vaccination
Incidence density of symptomatic COVID-19 cases in different age groups
Time frame: 14 days after full vaccination
Incidence of solicited local adverse events
Time frame: 0-7 days after each vaccination
Incidence of solicited general adverse events
Time frame: 0-7 days after each vaccination
Incidence of unsolicited adverse events
Time frame: 0-28 days after each vaccination
Incidence of SAE
Time frame: from the 1st dose through the end of study
Incidence of AESI
Time frame: from the 1st dose through the end of study
Seroconversion rate of SARS-CoV-2 neutralizing antibody
Time frame: 28 days, 90 days, 180 days and 360 days after full vaccination
Geometric mean titer of SARS-CoV-2 neutralizing antibody
Time frame: 28 days, 90 days, 180 days and 360 days after full vaccination
Geometric mean fold increase of SARS-CoV-2 neutralizing antibody
Time frame: 28 days, 90 days, 180 days and 360 days after full vaccination
Seroconversion rate of SARS-CoV-2 IgG binding antibody
Time frame: 28 days, 90 days, 180 days and 360 days after full vaccination
Geometric mean titer of SARS-CoV-2 IgG binding antibody
Time frame: 28 days, 90 days, 180 days and 360 days after full vaccination
Geometric mean fold increase of SARS-CoV-2 IgG binding antibody
Time frame: 28 days, 90 days, 180 days and 360 days after full vaccination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2021.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SARS-CoV-2 Vaccine (Vero Cells), Inactivated in people with COVID-19, run by Shenzhen Kangtai Biological Products Co., LTD.
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 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
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 Guifan Li, M.S (+861059613591, liguifan@biominhai.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence density of symptomatic COVID-19 cases (time frame: 14 days after full 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 22 Apr 2021.