COVID-19Phase 1NCT05003479
Clinical Trial of SARS-CoV-2 Vaccine (Vero Cells), Inactivated in Healthy Population Aged 3 to 17 Years(COVID-19)
A Phase 1 study testing SARS-CoV-2 Vaccine (Vero Cells), Inactivated in people with COVID-19, run by Shenzhen Kangtai Biological Products Co., LTD at 1 site in China.
Trial summary
This study is a randomized, double-blinded, and placebo controlled phase Ⅰ clinical trial of the SARS-CoV-2 inactivated vaccine to evaluate the safety and immunogenicity of the experimental vaccine in healthy population aged 3 to 17 years. Read more about this study
- Who is it for?
- Ages 3 to 17 yearsHealthy 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
- 84 participants
- Where
- 1 siteChina
- Study dates
- Aug 2021to Oct 2022
- Phase
- Phase 1
- 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 3 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy residents aged 3 to 17 years at the time of consent
- Subjects and/or their guardian agree to sign the informed consent forms voluntarily.
- Be able to comply with study requirements/procedures.
- Axillary temperature ≤ 37.0℃
Who cannot join
- Within 14 days before vaccination, subjects have been abroad and to villages/communities experienced COVID-19 epidemics, and in contact with COVID-19 cases or suspected cases. Subjects are under isolation observation, or living in the villages/communities with COVID-19 cases or suspected cases;
- Confirmed cases, suspected cases or asymptomatic cases with COVID-19 (refer to Information System of China Disease Prevention and Control);
- Subjects with history of SARS virus infection by self-reported;
- Positive in throat swab through RT-PCR;
- History of vaccination of various COVID-19 vaccines or positive in SARS-CoV-2 antibody test;
- Positive urine pregnancy test for females with menarche
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- With abnormal indicators, such as blood biochemistry, blood routine, urine routine, thyroid function and coagulation function which might show clinical meaning, before administration;
- History of severe allergic reactions (such as acute anaphylaxis, urticaria, skin eczema, dyspnea, angioneurotic edema or abdominal pain) or allergy to known composition of inactivated SARS-CoV-2 vaccine;
- History or family history of convulsion, epilepsy, encephalopathy or mental illness;
- Subjects with congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.;
- Subjects with known or suspected diseases include: severe respiratory diseases, severe cardiovascular diseases, severe liver and kidney diseases, drug-uncontrollable hypertension, diabetic complications, malignant tumors, various acute diseases or acute onset of chronic diseases;
- Diagnosed with congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia or other autoimmune diseases;
- History of coagulation dysfunction (e.g. Coagulation factor deficiency, coagulation disease);
- Subjects receiving anti-TB treatment;
- Subjects receiving other research drugs within 6 months before vaccination;
- Subjects receiving immunotherapy or inhibitor therapy within 3 months (consistently oral or infusion for more than 14 days);
- Subjects receiving blood products within 3 months before administration;
- Subjects vaccinated with live attenuated vaccine within 14 days before vaccination;
- Subjects vaccinated with other vaccine within 7 days before vaccination;
- The researchers shall judge the other conditions which might be not in compliance with the requirements of this clinical trial.
Trial locations and contacts
1 site in 1 country.
China1 site
Hunan Provincial Center for Diseases Control and Prevention
Changsha, Hunan, 410005
Tao Huang, +8673184305935, ymlc01@hncdc.com
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Phase Ⅰ Clinical Study to Evaluate the Safety and Immunogenicity of SARS-CoV-2 Vaccine (Vero Cells), Inactivated in Healthy Population Aged 3 to 17 Years
This study is a randomized, double-blinded, and placebo controlled phase Ⅰ clinical trial of the SARS-CoV-2 inactivated vaccine to evaluate the safety and immunogenicity of the experimental vaccine in healthy population aged 3 to 17 years.
- 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 of adverse reactions/events
Measured: 0-28 days after each vaccination
Secondary outcomes (8)
Incidence of Serious Adverse Events (SAE)
Measured: within 12 months post full vaccination
Incidence of abnormal indicators of laboratory safety examinations(including blood routine, blood biochemistry, urine routine, thyroid function and coagulation function)
Measured: Day 3 after each dose of vaccination
Geometric mean titer of SARS-CoV-2 neutralizing antibody
Measured: 28 days, 3 months, 6 months and 12 months post full vaccination
Geometric mean titer of SARS-CoV-2 IgG binding antibody
Measured: 28 days, 3 months, 6 months and 12 months post full vaccination
Seroconversion rate of SARS-CoV-2 neutralizing antibody
Measured: 28 days post full vaccination
Seroconversion rate of SARS-CoV-2 IgG binding antibody
Measured: 28 days post full vaccination
Seropositive rate of SARS-CoV-2 neutralizing antibody
Measured: 3 months, 6 months and 12 months post full vaccination
Seropositive rate of SARS-CoV-2 IgG binding antibody
Measured: 3 months, 6 months and 12 months post full vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2021
- Study startAug 2021 (estimated)
- Primary completionSep 2022 (estimated)
- Study completionOct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 84 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, Hunan Provincial Center for Disease Control and Prevention
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05003479
- Sponsor's protocol ID
- 2020L001-2A
- Status last verified
- Aug 2021
- First submitted
- 10 Aug 2021
- Last updated
- 18 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Liu J, Huang B, Li G, Huang T, Wang D, Zhang L, Deng Y, Chang X, Liu Y, Li W, Zhang S, Huang W, Tan W, Gao L. Immunogenicity and Safety of a SARS-CoV-2 Inactivated Vaccine KCONVAC in Chinese Children: Randomized, Double-blind, Placebo-controlled Phase 1 and 2 Trials. Pediatr Infect Dis J. 2023 Dec 1;42(12):1136-1142. doi: 10.1097/INF.0000000000004085. Epub 2023 Sep 4.
PubMed 37967148
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Phase Ⅰ Clinical Study to Evaluate the Safety and Immunogenicity of SARS-CoV-2 Vaccine (Vero Cells), Inactivated in Healthy Population Aged 3 to 17 Years
- ClinicalTrials.gov ID
- NCT05003479
- Acronym / sponsor ID
- 2020L001-2A
- Conditions
- COVID-19
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Shenzhen Kangtai Biological Products Co., LTDIndustry (pharma, biotech, devices)
- Collaborators
- Beijing Minhai Biotechnology Co., Ltd, Hunan Provincial Center for Disease Control and Prevention
- Study start
- Aug 2021 (estimated)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 12 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 study is a randomized, double-blinded, and placebo controlled phase Ⅰ clinical trial of the SARS-CoV-2 inactivated vaccine to evaluate the safety and immunogenicity of the experimental vaccine in healthy population aged 3 to 17 years.
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
- 3 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Healthy residents aged 3 to 17 years at the time of consent
- Subjects and/or their guardian agree to sign the informed consent forms voluntarily.
- Be able to comply with study requirements/procedures.
- Axillary temperature ≤ 37.0℃
Key exclusion criteria (20 listed)
- Within 14 days before vaccination, subjects have been abroad and to villages/communities experienced COVID-19 epidemics, and in contact with COVID-19 cases or suspected cases. Subjects are under isolation observation, or living in the villages/communities with COVID-19 cases or suspected cases;
- Confirmed cases, suspected cases or asymptomatic cases with COVID-19 (refer to Information System of China Disease Prevention and Control);
- Subjects with history of SARS virus infection by self-reported;
- Positive in throat swab through RT-PCR;
- History of vaccination of various COVID-19 vaccines or positive in SARS-CoV-2 antibody test;
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 of adverse reactions/events
Time frame: 0-28 days after each vaccination
8 secondary outcomes
Incidence of Serious Adverse Events (SAE)
Time frame: within 12 months post full vaccination
Incidence of abnormal indicators of laboratory safety examinations(including blood routine, blood biochemistry, urine routine, thyroid function and coagulation function)
Time frame: Day 3 after each dose of vaccination
Geometric mean titer of SARS-CoV-2 neutralizing antibody
Time frame: 28 days, 3 months, 6 months and 12 months post full vaccination
Geometric mean titer of SARS-CoV-2 IgG binding antibody
Time frame: 28 days, 3 months, 6 months and 12 months post full vaccination
Seroconversion rate of SARS-CoV-2 neutralizing antibody
Time frame: 28 days post full vaccination
Seroconversion rate of SARS-CoV-2 IgG binding antibody
Time frame: 28 days post full vaccination
Seropositive rate of SARS-CoV-2 neutralizing antibody
Time frame: 3 months, 6 months and 12 months post full vaccination
Seropositive rate of SARS-CoV-2 IgG binding antibody
Time frame: 3 months, 6 months and 12 months post full vaccination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2021.
- Derived from this study: PubMed 37967148Liu J, Huang B, Li G, Huang T, Wang D, Zhang L, Deng Y, Chang X, Liu Y, Li W, Zhang S, Huang W, Tan W, Gao L. Immunogenicity and Safety of a SARS-CoV-2 Inactivated Vaccine KCONVAC in Chinese Children: Randomized, Double-blind, Placebo-controlled Phase 1 and 2 Trials. Pediatr Infect Dis J. 2023 Dec 1;42(12):1136-1142. doi: 10.1097/INF.0000000000004085. Epub 2023 Sep 4.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SARS-CoV-2 Vaccine (Vero Cells), Inactivated in people with COVID-19, run by Shenzhen Kangtai Biological Products 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: status not confirmed, as of the sponsor's last update on 18 Aug 2021. 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 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.
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 of adverse reactions/events (time frame: 0-28 days after each vaccination). 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 NCT05003479, which also lists 1 linked publication.
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 Aug 2021.