Influenza, HumanPhase 4NCT04790851
Evaluation of Immunogenicity and Safety of Combined Immunization of COVID-19 Vaccine (Produced in Beijing) and PPV23 / IIV4
A Phase 4 study testing COVAX+IIV4; COVAX+PPV23, COVAX only (1st and 2nd dose) and IIV4 for the 1st dose and PPV23 for the 2nd dose in people with Influenza, Human and Pneumonia, Pneumococcal, run by China National Biotec Group Company Limited at 3 sites in China.
Trial summary
Subjects will be recruited and divided into 3 groups: Experimental Group (384 subjects): 1st dose : combined vaccination of COVAX+IIV4, 2nd dose: combined vaccination of COVAX+PPV23; Control Group A (384 subjects): 1st dose: COVAX only, 2nd dose: COVAX only; Control Group B (384 subjects): 1st dose: IIV4 only, 2nd… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza, Human, Pneumonia, Pneumococcal, Covid19
- What is being tested?
- COVAX+IIV4; COVAX+PPV23, COVAX only (1st and 2nd dose) and IIV4 for the 1st dose and PPV23 for the 2nd dose
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,133 participants
- Where
- 3 sitesChina
- Study dates
- 10 Mar 2021to 5 Sep 2021
- Phase
- Phase 4
- 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
- ≥18 years old when enrolled;
- Participants signing the informed consent;
- Being able to participate in all planned follow-ups and accomplish all research procedures including completing a diary card and coming back for interview;
- Having not been administered any pneumonia vaccine or COVID-19 vaccine, and having not been administered an influenza vaccine in the current season before enrollment;
- ≥14 days from the most recent vaccination;
- Before enrollment, the body temperature is ≤37.0C as confirmed by medical history and clinical examination.
Who cannot join
- Having a history of COVID-19 or a positive nucleic acid test for COVID-19;
- Having a history or a family history of allergy, convulsion, epilepsy, brain disease, or mental illness;
- Being allergic to any component of vaccines, or having a history of severe allergic reaction to any vaccine;
- Having immunodeficiency disorder, during treatment of malignant tumor, having immunodeficiency induced by immunosuppressants (oral steroid hormones) or HIV, or having a family member with close contact who suffers from congenital immune disorder;
- Having injection of non-specific immunoglobulin within 1 month prior to enrollment;
- Having acute febrile illness or communicable disease;
Show all 15Show fewer
- Having a history of confirmed thrombocytopenia or other coagulation disorders, which may cause contraindications for a subcutaneous injection;
- Having severe chronic disease or acute exacerbation of chronic disease, or having uncontrolled hypertension or diabetes;
- Having various infectious, pyogenic, or allergic skin diseases;
- Women in pregnancy or lactation or participants who plan for a baby within 3 months after vaccination should delay the vaccination;
- Having any condition that may affect trial assessment as determined by researchers.
- Having any serious adverse event related to the first dose vaccination;
- After vaccination, having systemic adverse reaction or allergic reaction with a severity of grade 3 or higher as determined by researchers;
- Having a newly emerging condition that meets the exclusion criteria for the first dose;
- Having any condition that may affect trial assessment as determined by researchers.
Trial locations and contacts
3 sites in 1 country.
China3 sites
Sichuan Center for Disease Control and Prevention
Chengdu, 610041
Shanghai Municipal Center for Disease Control and Prevention
Shanghai, 200336
Shanxi Provincial Center for Disease Control and Prevention
Taiyuan, 030012
About this study
Official title: A Randomized, Controlled, Multicenter Phase 4 Clinic Trial to Evaluate the Immunogenicity and Safety of Combined Immunization of Inactivated SARS-CoV-2 Vaccines (Vero Cell) (COVAX) (Produced in Beijing) and 23-valent Pneumococcal Polysaccharide Vaccine (PPV23) or Quadrivalent Inactivated Influenza Vaccine (IIV4)
Subjects will be recruited and divided into 3 groups:
Experimental Group (384 subjects): 1st dose : combined vaccination of COVAX+IIV4, 2nd dose: combined vaccination of COVAX+PPV23; Control Group A (384 subjects): 1st dose: COVAX only, 2nd dose: COVAX only; Control Group B (384 subjects): 1st dose: IIV4 only, 2nd dose: PPV23 only.
Blood samples will be collected 3 times:
before the 1st dose of vaccinatioin; before the 2nd dose of vaccination; 28 days after the 2nd dose of vaccination.
The immunogenicity and safety of both experimental and control groups will be analyzed.
Read the detailed description
This randomized, parallel, controlled study is designed to evaluate the immunogenicity and safety of simultaneously immunization of COVAX + PPV23 and COVAX + IIV4.
1152 subjects are divided into 3 groups, including 1 experimental group and 2 control groups (control group A and B). Each group includes 384 subjects respectively.
Experimental Group (384 subjects) will receive: 1st dose : combined vaccination of COVAX+IIV4, 2nd dose: combined vaccination of COVAX+PPV23; Control Group A (384 subjects) will receive: 1st dose: COVAX only, 2nd dose: COVAX only; Control Group B (384 subjects) will receive: 1st dose: IIV4 only, 2nd dose: PPV23 only.
Specifically, each group will be divided again. Each 384-subject group is divided again into 2 age-based subgroups: (1) 18-59 years old; (2) ≥60 years old.
Each subgroup includes 192 subjects respectively. Blood samples will be collected 3 times: (1) before the 1st dose of vaccinatioin; (2) before the 2nd dose of vaccination; (3) 28 days after the 2nd dose of vaccination.
To evaluate the immunogenicity, the investigators will detect and compare the neutralizing antibody levels, the seroconversion rates and antibody geometric mean concentrations.
The safety of all groups will be monitored as well.
- Conditions
- Influenza, Human, Pneumonia, Pneumococcal, Covid19
- Being tested
- COVAX+IIV4; COVAX+PPV23, COVAX only (1st and 2nd dose), IIV4 for the 1st dose and PPV23 for the 2nd dose
- Medical subject headings
- Influenza, Human, Pneumonia, Pneumococcal, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVAX+IIV4; COVAX+PPV23Biological
1st dose : combined vaccination of COVAX+IIV4; 2nd dose: combined vaccination of COVAX+PPV23
COVAX only (1st and 2nd dose)Biological
1st dose: COVAX only; 2nd dose: COVAX only
IIV4 for the 1st dose and PPV23 for the 2nd doseBiological
1st dose: IIV4 only; 2nd dose: PPV23 only
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Experimental Group (384 subjects) will receive: 1st dose : combined vaccination of COVAX+IIV4; 2nd dose: combined vaccination of COVAX+PPV23 Receives: Biological: COVAX+IIV4; COVAX+PPV23 |
| Control group A | Active comparator | Control Group A (384 subjects) will receive: 1st dose: COVAX only; 2nd dose: COVAX only Receives: Biological: COVAX only (1st and 2nd dose) |
| Control group B | Active comparator | Control Group B (384 subjects) will receive: 1st dose: IIV4 only; 2nd dose: PPV23 only Receives: Biological: IIV4 for the 1st dose and PPV23 for the 2nd dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seroconversion rate (COVAX)
the rate of positive seroconversion against coronavirus
Measured: Results obtained 28 days after the first dose (= right before the second dose)
Seroconversion rate (COVAX)
the rate of positive seroconversion against coronavirus
Measured: Results obtained after the second dose of vaccination (= 56 days after the first dose, or 28 days after the second dose)
Neutralizing antibody level (COVAX)
neutralizing antibody level against coronavirus
Measured: Baseline (before vaccination) results
Neutralizing antibody level (COVAX)
neutralizing antibody level against coronavirus
Measured: Results obtained 28 days after the first dose (= right before the second dose)
Neutralizing antibody level (COVAX)
neutralizing antibody level against coronavirus
Measured: Results obtained after the second dose of vaccination (= 56 days after the first dose, or 28 days after the second dose)
Seropositive rate (IIV4)
the rate of positive seroconversion against influenza A (H3N2, H1N1) type and B (BY, BV) type viruses
Measured: Baseline (before vaccination) results
Seroconversion rate (IIV4)
the rate of positive seroconversion against influenza A (H3N2, H1N1) type and B (BY, BV) type viruses
Measured: Results obtained 28 days after the first dose (= right before the second dose)
Seroconversion rate (IIV4)
the rate of positive seroconversion against influenza A (H3N2, H1N1) type and B (BY, BV) type viruses
Measured: Results obtained after the second dose of vaccination (= 56 days after the first dose, or 28 days after the second dose)
Hemmagglution inhibition antibody level (IIV4)
Hemmagglution inhibition antibody levels against influenza A (H3N2, H1N1) type and B (BY, BV) type viruses
Measured: Baseline (before vaccination) results
Hemmagglution inhibition antibody level (IIV4)
Hemmagglution inhibition antibody levels against influenza A (H3N2, H1N1) type and B (BY, BV) type viruses
Measured: Results obtained 28 days after the first dose (= right before the second dose)
Hemmagglution inhibition antibody level (IIV4)
Hemmagglution inhibition antibody levels against influenza A (H3N2, H1N1) type and B (BY, BV) type viruses
Measured: Results obtained after the second dose of vaccination (= 56 days after the first dose, or 28 days after the second dose)
Seroconversion rate (PPV23)
the rate of positive seroconversion against 23 pneumococcal serotypes
Measured: Results obtained 28 days after the first dose (= right before the second dose)
Seroconversion rate (PPV23)
the rate of positive seroconversion against 23 pneumococcal serotypes
Measured: Results obtained after the second dose of vaccination (= 56 days after the first dose, or 28 days after the second dose)
Neutralizing antibody level (PPV23)
Neutralizing antibody level against 23 pneumococcal serotypes
Measured: Baseline (before vaccination) results
Neutralizing antibody level (PPV23)
Neutralizing antibody level against 23 pneumococcal serotypes
Measured: Results obtained 28 days after the first dose (= right before the second dose)
Neutralizing antibody level (PPV23)
Neutralizing antibody level against 23 pneumococcal serotypes
Measured: Results obtained after the second dose of vaccination (= 56 days after the first dose, or 28 days after the second dose)
Secondary outcomes (1)
Adverse events following vaccination
analyse the incidence of adverse events following immunization, both solicited and unsolicited
Measured: 0-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2021
- Study start10 Mar 2021
- Primary completion5 Sep 2021
- Study completion5 Sep 2021
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 Influenza, HumanStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,133 participants (actual)
Sponsor and investigators
- Lead sponsor
- China National Biotec Group Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Chengdu Institute of Biological Products Co.,Ltd., Changchun Institute of Biological Products Co., Ltd., Beijing Institute of Biological Products Co Ltd., Sichuan Center for Disease Control and Prevention, Shanghai Municipal Center for Disease Control and Prevention, Centers for Disease Control and Prevention, China
- Responsible party
- Sponsor
- Investigators
- Xiaodong Sun, Principal investigator, Shanghai Municipal Center for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04790851
- Sponsor's protocol ID
- COVAX+PPV23+IIV4-Beijing
- Status last verified
- Oct 2021
- First submitted
- 8 Mar 2021
- Last updated
- 20 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chen H, Huang Z, Chang S, Hu M, Lu Q, Zhang Y, Wang H, Xiao Y, Wang H, Ge Y, Zou Y, Cui F, Han S, Zhang M, Wang S, Zhu X, Zhang B, Li Z, Ren J, Chen X, Ma R, Zhang L, Guo X, Luo L, Sun X, Yang X. Immunogenicity and safety of an inactivated SARS-CoV-2 vaccine (Sinopharm BBIBP-CorV) coadministered with quadrivalent split-virion inactivated influenza vaccine and 23-valent pneumococcal polysaccharide vaccine in China: A multicentre, non-inferiority, open-label, randomised, controlled, phase 4 trial. Vaccine. 2022 Aug 26;40(36):5322-5332. doi: 10.1016/j.vaccine.2022.07.033. Epub 2022 Jul 29.
PubMed 35931636
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Multicenter Phase 4 Clinic Trial to Evaluate the Immunogenicity and Safety of Combined Immunization of Inactivated SARS-CoV-2 Vaccines (Vero Cell) (COVAX) (Produced in Beijing) and 23-valent Pneumococcal Polysaccharide Vaccine (PPV23) or Quadrivalent Inactivated Influenza Vaccine (IIV4)
- ClinicalTrials.gov ID
- NCT04790851
- Acronym / sponsor ID
- COVAX+PPV23+IIV4-Beijing
- Conditions
- Influenza, Human, Pneumonia, Pneumococcal, Covid19
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,133 participants (actual)
- Lead sponsor
- China National Biotec Group Company LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Chengdu Institute of Biological Products Co.,Ltd., Changchun Institute of Biological Products Co., Ltd., Beijing Institute of Biological Products Co Ltd., Sichuan Center for Disease Control and Prevention, Shanghai Municipal Center for Disease Control and Prevention, Centers for Disease Control and Prevention, China
- Study start
- 10 Mar 2021 (actual)
- Primary completion
- 5 Sep 2021 (actual)
- Study completion
- 5 Sep 2021 (actual)
- First posted
- 10 Mar 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.
Subjects will be recruited and divided into 3 groups:
Experimental Group (384 subjects): 1st dose : combined vaccination of COVAX+IIV4, 2nd dose: combined vaccination of COVAX+PPV23; Control Group A (384 subjects): 1st dose: COVAX only, 2nd dose: COVAX only; Control Group B (384 subjects): 1st dose: IIV4 only, 2nd dose: PPV23 only.
Blood samples will be collected 3 times:
before the 1st dose of vaccinatioin; before the 2nd dose of vaccination; 28 days after the 2nd dose of vaccination.
The immunogenicity and safety of both experimental and control groups will be analyzed.
Detailed description
This randomized, parallel, controlled study is designed to evaluate the immunogenicity and safety of simultaneously immunization of COVAX + PPV23 and COVAX + IIV4.
1152 subjects are divided into 3 groups, including 1 experimental group and 2 control groups (control group A and B). Each group includes 384 subjects respectively.
Experimental Group (384 subjects) will receive: 1st dose : combined vaccination of COVAX+IIV4, 2nd dose: combined vaccination of COVAX+PPV23; Control Group A (384 subjects) will receive: 1st dose: COVAX only, 2nd dose: COVAX only; Control Group B (384 subjects) will receive: 1st dose: IIV4 only, 2nd dose: PPV23 only.
Specifically, each group will be divided again. Each 384-subject group is divided again into 2 age-based subgroups: (1) 18-59 years old; (2) ≥60 years old.
Each subgroup includes 192 subjects respectively. Blood samples will be collected 3 times: (1) before the 1st dose of vaccinatioin; (2) before the 2nd dose of vaccination; (3) 28 days after the 2nd dose of vaccination.
To evaluate the immunogenicity, the investigators will detect and compare the neutralizing antibody levels, the seroconversion rates and antibody geometric mean concentrations.
The safety of all groups will be monitored as well.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Biological: COVAX+IIV4; COVAX+PPV23Experimental Group (384 subjects) will receive: 1st dose : combined vaccination of COVAX+IIV4; 2nd dose: combined vaccination of COVAX+PPV23 |
| Control group A | Active comparator | Biological: COVAX only (1st and 2nd dose)Control Group A (384 subjects) will receive: 1st dose: COVAX only; 2nd dose: COVAX only |
| Control group B | Active comparator | Biological: IIV4 for the 1st dose and PPV23 for the 2nd doseControl Group B (384 subjects) will receive: 1st dose: IIV4 only; 2nd dose: PPV23 only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ≥18 years old when enrolled;
- Participants signing the informed consent;
- Being able to participate in all planned follow-ups and accomplish all research procedures including completing a diary card and coming back for interview;
- Having not been administered any pneumonia vaccine or COVID-19 vaccine, and having not been administered an influenza vaccine in the current season before enrollment;
- ≥14 days from the most recent vaccination;
Key exclusion criteria (15 listed)
- Having a history of COVID-19 or a positive nucleic acid test for COVID-19;
- Having a history or a family history of allergy, convulsion, epilepsy, brain disease, or mental illness;
- Being allergic to any component of vaccines, or having a history of severe allergic reaction to any vaccine;
- Having immunodeficiency disorder, during treatment of malignant tumor, having immunodeficiency induced by immunosuppressants (oral steroid hormones) or HIV, or having a family member with close contact who suffers from congenital immune disorder;
- Having injection of non-specific immunoglobulin within 1 month prior to enrollment;
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 |
|---|---|---|
| COVAX+IIV4; COVAX+PPV231st dose : combined vaccination of COVAX+IIV4; 2nd dose: combined vaccination of COVAX+PPV23 | Biological | Experimental group |
| COVAX only (1st and 2nd dose)1st dose: COVAX only; 2nd dose: COVAX only | Biological | Control group A |
| IIV4 for the 1st dose and PPV23 for the 2nd dose1st dose: IIV4 only; 2nd dose: PPV23 only | Biological | Control group B |
Primary outcome
Seroconversion rate (COVAX)
Time frame: Results obtained 28 days after the first dose (= right before the second dose)
the rate of positive seroconversion against coronavirus
Seroconversion rate (COVAX)
Time frame: Results obtained after the second dose of vaccination (= 56 days after the first dose, or 28 days after the second dose)
the rate of positive seroconversion against coronavirus
Neutralizing antibody level (COVAX)
Time frame: Baseline (before vaccination) results
neutralizing antibody level against coronavirus
Neutralizing antibody level (COVAX)
Time frame: Results obtained 28 days after the first dose (= right before the second dose)
neutralizing antibody level against coronavirus
Neutralizing antibody level (COVAX)
Time frame: Results obtained after the second dose of vaccination (= 56 days after the first dose, or 28 days after the second dose)
neutralizing antibody level against coronavirus
Seropositive rate (IIV4)
Time frame: Baseline (before vaccination) results
the rate of positive seroconversion against influenza A (H3N2, H1N1) type and B (BY, BV) type viruses
Seroconversion rate (IIV4)
Time frame: Results obtained 28 days after the first dose (= right before the second dose)
the rate of positive seroconversion against influenza A (H3N2, H1N1) type and B (BY, BV) type viruses
Seroconversion rate (IIV4)
Time frame: Results obtained after the second dose of vaccination (= 56 days after the first dose, or 28 days after the second dose)
the rate of positive seroconversion against influenza A (H3N2, H1N1) type and B (BY, BV) type viruses
Hemmagglution inhibition antibody level (IIV4)
Time frame: Baseline (before vaccination) results
Hemmagglution inhibition antibody levels against influenza A (H3N2, H1N1) type and B (BY, BV) type viruses
Hemmagglution inhibition antibody level (IIV4)
Time frame: Results obtained 28 days after the first dose (= right before the second dose)
Hemmagglution inhibition antibody levels against influenza A (H3N2, H1N1) type and B (BY, BV) type viruses
Hemmagglution inhibition antibody level (IIV4)
Time frame: Results obtained after the second dose of vaccination (= 56 days after the first dose, or 28 days after the second dose)
Hemmagglution inhibition antibody levels against influenza A (H3N2, H1N1) type and B (BY, BV) type viruses
Seroconversion rate (PPV23)
Time frame: Results obtained 28 days after the first dose (= right before the second dose)
the rate of positive seroconversion against 23 pneumococcal serotypes
Seroconversion rate (PPV23)
Time frame: Results obtained after the second dose of vaccination (= 56 days after the first dose, or 28 days after the second dose)
the rate of positive seroconversion against 23 pneumococcal serotypes
Neutralizing antibody level (PPV23)
Time frame: Baseline (before vaccination) results
Neutralizing antibody level against 23 pneumococcal serotypes
Neutralizing antibody level (PPV23)
Time frame: Results obtained 28 days after the first dose (= right before the second dose)
Neutralizing antibody level against 23 pneumococcal serotypes
Neutralizing antibody level (PPV23)
Time frame: Results obtained after the second dose of vaccination (= 56 days after the first dose, or 28 days after the second dose)
Neutralizing antibody level against 23 pneumococcal serotypes
1 secondary outcome
Adverse events following vaccination
Time frame: 0-6 months
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 20 Oct 2021.
- Derived from this study: PubMed 35931636Chen H, Huang Z, Chang S, Hu M, Lu Q, Zhang Y, Wang H, Xiao Y, Wang H, Ge Y, Zou Y, Cui F, Han S, Zhang M, Wang S, Zhu X, Zhang B, Li Z, Ren J, Chen X, Ma R, Zhang L, Guo X, Luo L, Sun X, Yang X. Immunogenicity and safety of an inactivated SARS-CoV-2 vaccine (Sinopharm BBIBP-CorV) coadministered with quadrivalent split-virion inactivated influenza vaccine and 23-valent pneumococcal polysaccharide vaccine in China: A multicentre, non-inferiority, open-label, randomised, controlled, phase 4 trial. Vaccine. 2022 Aug 26;40(36):5322-5332. doi: 10.1016/j.vaccine.2022.07.033. Epub 2022 Jul 29.
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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.
Xiaodong Sun principal investigator
Shanghai Municipal Center for Disease Control and Prevention
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing COVAX+IIV4; COVAX+PPV23, COVAX only (1st and 2nd dose) and IIV4 for the 1st dose and PPV23 for the 2nd dose in people with Influenza, Human and Pneumonia, Pneumococcal, run by China National Biotec Group Company Limited at 3 sites 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 6 inclusion and 15 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 20 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Seroconversion rate (COVAX) (time frame: Results obtained 28 days after the first dose (= right before the second dose)). The study lists 16 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 NCT04790851, 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 20 Oct 2021.