Meningococcal MeningitisPhase 2NCT06337071
A Study of the ACYW135 Meningococcal Polysaccharide Conjugate Vaccine
A Phase 2 study testing ACYW135 Meningococcal Polysaccharide Conjugate Vaccine and ACYW135 Meningococcal Polysaccharide Vaccine in people with Meningococcal Meningitis, run by Aimei Vacin BioPharm (Zhejiang) Co., Ltd. at 1 site in China.
Trial summary
The purpose of this study was to explore the safety and immunogenicity of the experimental vaccine compared with the control vaccines. It is planed to enroll a total of 1,200 subjects, including 300 subjects in each of the 3-5 months old, 6-11 months old, 12-23 months old and 2-15 years old groups, who will be… Read more about this study
- Who is it for?
- Ages 3 months to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Meningococcal Meningitis
- What is being tested?
- ACYW135 Meningococcal Polysaccharide Conjugate Vaccine and ACYW135 Meningococcal Polysaccharide Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 1 siteChina
- Study dates
- 20 Mar 2024to Jun 2025
- Phase
- Phase 2
- 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 months to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 3~5 months old:
- 3~5 months old;
- The subject's legal guardian voluntarily agrees to his or her child's participation in this trial and signs an informed consent form;
- The subject and/or the subject's legal guardian can comply with the relevant requirements of the clinical trial protocol;
- Have not vaccinated by any meningococcal vaccine in the past.
- 6~23 months old:
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- 6~23 months old;
- The subject's legal guardian voluntarily agrees to his or her child's participation in this trial and signs an informed consent form;
- The subject and/or the subject's legal guardian can comply with the relevant requirements of the clinical trial protocol;
- Have not vaccinated by any other meningococcal vaccines except meningococcal group A polysaccharide vaccine in the past. If have 1 dose vaccinated of meningococcal group A polysaccharide vaccine, it will be 3 months or more separated from the previous dose of meningococcal group A polysaccharide vaccine. If two doses of meningococcal group A polysaccharide vaccine have been vaccinated, the interval between the last dose of meningococcal group A polysaccharide vaccine should be more than 6 months or more.
- 2~15 years old:
- 2~15 years old;
- The subject's legal guardian voluntarily agrees to his or her child's participation in this trial and signs an informed consent form (subjects aged 8-15 years old are also required to sign an informed consent form);
- The subject and/or the subject's legal guardian can comply with the relevant requirements of the clinical trial protocol; Subjects aged 2 to 6 years old have not previously been vaccinated with any meningococcal vaccine other than meningococcal polysaccharide vaccine, and the interval between the previous dose of meningococcal polysaccharide vaccine and vaccination should be more than 12 months or more; 7~15 years old participants have not received any meningococcal vaccine in the past 3 years.
Who cannot join
- The temperature before vaccination on the day of vaccination is >37.0℃;
- Have a history of invasive disease caused by meningococci confirmed by culture;
- Have a history of severe allergic reactions that require medical intervention (such as oral and throat swelling, dyspnea, hypotension or shock caused by allergies); have a history of allergies to vaccines or vaccine components (especially those allergic to diphtheria toxoid), and have concerns about vaccination History of other serious adverse reactions;
- Those with a clearly diagnosed history of thrombocytopenia or other coagulation disorders, which may cause contraindications for intramuscular injection;
- Suffer from acute disease or acute attack of chronic disease within 3 days before vaccination;
- Have a history of epilepsy, progressive neurological disease, Guillain-Barré syndrome, convulsions (except simple febrile convulsions) and mental illness;
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- Known or suspected immunological dysfunction, including immunosuppressant treatment (radiation therapy, chemotherapy, corticosteroids, antimetabolites, cytotoxic drugs), human immunodeficiency virus (HIV) infection, etc.;
- Known severe congenital malformations; suffering from developmental disabilities or clinically diagnosed serious chronic diseases (such as Down syndrome, diabetes, sickle cell anemia or neurological diseases);
- Known or suspected to have serious diseases that are judged by the researcher to affect vaccination, including respiratory diseases, digestive system diseases, endocrine system diseases, immune system diseases, cardiovascular diseases, liver and kidney diseases, malignant tumors, skin diseases, etc. ;
- Long-term use (continuous use for ≥14 days) of immunosuppressants or other immunomodulatory drugs (such as corticosteroids: prednisone or similar drugs) within 6 months before vaccination with the experimental vaccine, but local use (such as ointments, eye drops, inhalants, or nasal sprays), topical administration should not exceed the dosage recommended in the label;
- Have received blood products including gamma globulin or immune globulin treatment within 3 months before vaccination (<3 months);
- Asplenia or functional asplenia, asplenia or splenectomy caused by any condition;
- Have been vaccinated with live attenuated vaccines within 14 days (including 14 days) before vaccination, and have been vaccinated with other subunits, inactivated vaccines or recombinant protein vaccines other than live attenuated vaccines within 7 days (including 7 days);
- Currently participating in or planning to participate in other drug clinical trials during the entire trial period after receiving the experimental vaccine;
- Any situation that the researcher believes may affect the evaluation of the trial.
Trial locations and contacts
1 site in 1 country.
China1 site
Yunnan Center For Disease Control and Prevention
Kunming, Yunnan, 650022
ZHENG Yan, +8687163627796, yaqueer_zy@163.com
About this study
Official title: A Phase II Clinical Trial to Evaluate the Immunogenicity and Safety of the ACYW135 Meningococcal Polysaccharide Conjugate Vaccine in People Aged 3 Months to 15 Years Old in a Randomized, Double-blind, Parallel Controlled Design
The purpose of this study was to explore the safety and immunogenicity of the experimental vaccine compared with the control vaccines. It is planed to enroll a total of 1,200 subjects, including 300 subjects in each of the 3-5 months old, 6-11 months old, 12-23 months old and 2-15 years old groups, who will be randomly assigned to the trial in a 1:1 ratio to study group or control group. The 3-5 month-old group will have three doses vaccination at 0, 1 and 2 month, and a booster dose at 12 months of age; the 6-11month-old and 12-23 month-old groups will each have total two doses vaccination; the 2-15 year-old group will have one dose vaccination.
Read the detailed description
The purpose of this study was to evaluate the safety and immunogenicity of the experimental vaccine(ACYW135 Meningococcal Polysaccharide Conjugate Vaccine) compared with the control vaccines(ACYW135 Meningococcal Polysaccharide Conjugate Vaccine and ACYW135 Meningococcal Polysaccharide Vaccine). It is planed to enroll a total of 1,200 subjects, including 300 subjects in each of the 3-5 months old, 6-11 months old, 12-23 months old and 2-15 years old groups, who will be randomly assigned to the trial in a 1:1 ratio to study group or control group. The 3-5 month-old group will have three doses vaccination at 0, 1 and 2 month, and a booster dose at 12 months of age; the 6-11month-old and 12-23 month-old groups will each have total two doses vaccination(at month 0, 1 or at month 0, 3); the 2-15 year-old group will have one dose vaccination. The immunogenicity and immune persistence will be evaluated by rabbit complement serum bactericidal assay.
- Conditions
- Meningococcal Meningitis
- Being tested
- ACYW135 Meningococcal Polysaccharide Conjugate Vaccine, ACYW135 Meningococcal Polysaccharide Vaccine
- Medical subject headings
- Meningitis, Meningococcal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACYW135 Meningococcal Polysaccharide Conjugate VaccineBiological
ACYW135 Meningococcal Polysaccharide Conjugate Vaccine was produced by meningococcal polysaccharide from group A, C, Y, W135 and conjugated protein CRM197.
ACYW135 Meningococcal Polysaccharide VaccineBiological
ACYW135 Meningococcal Polysaccharide Vaccine was produced by meningococcal polysaccharide from group A, C, Y, W135.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group 2~15 years | Experimental | 2~15 years old participants who vaccinated by experimental vaccine Receives: Biological: ACYW135 Meningococcal Polysaccharide Conjugate Vaccine |
| Control Group 2~15 years | Active comparator | 2~15 years old participants who vaccinated by control vaccine 2 Receives: Biological: ACYW135 Meningococcal Polysaccharide Vaccine |
| Experimental Group 6~23 months(0,1) | Experimental | 6~23 months old participants who vaccinated by experimental vaccine at month 0 and 1 Receives: Biological: ACYW135 Meningococcal Polysaccharide Conjugate Vaccine |
| Control Group 6~23 months(0,1) | Active comparator | 6~23 months old participants who vaccinated by control vaccine 1 at month 0 and 1 Receives: Biological: ACYW135 Meningococcal Polysaccharide Conjugate Vaccine |
| Experimental Group 6~23 months(0,3) | Experimental | 6~23 months old participants who vaccinated by experimental vaccine at month 0 and 3 Receives: Biological: ACYW135 Meningococcal Polysaccharide Conjugate Vaccine |
| Control Group 6~23 months(0,3) | Active comparator | 6~23 months old participants who vaccinated by control vaccine 1 at month 0 and 3 Receives: Biological: ACYW135 Meningococcal Polysaccharide Conjugate Vaccine |
| Experimental Group 3~5 months | Experimental | 3~5 months old participants who vaccinated by experimental vaccine at month 0, 1, 2 for primary vaccination, and vaccinated by experimental vaccine at 12-month old for booster vaccination Receives: Biological: ACYW135 Meningococcal Polysaccharide Conjugate Vaccine |
| Control Group 3~5 months | Active comparator | 3~5 months old participants who vaccinated by control vaccine 1 at month 0, 1, 2 for primary vaccination, and vaccinated by control vaccine at 12-month old for booster vaccination Receives: Biological: ACYW135 Meningococcal Polysaccharide Conjugate Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunogenicity 1
To evaluate the positive conversion rate and geometric mean titer (GMT) of meningococcal serum bactericidal activity (rSBA) antibodies for meningococcal groups A, C, Y, and W135 at 30 days in 3~5 months old participants after primary vaccination
Measured: 30 days after primary vaccination
Immunogenicity 2
To evaluate the positive conversion rate and geometric mean titer (GMT) of meningococcal serum bactericidal activity (rSBA) antibodies for meningococcal groups A, C, Y, and W135 at 30 days in 6~23 months old participants after two doses vaccination
Measured: 30 days after two doses vaccination
Immunogenicity 3
To evaluate the positive conversion rate and geometric mean titer (GMT) of meningococcal serum bactericidal activity (rSBA) antibodies for meningococcal groups A, C, Y, and W135 at 30 days in 2~15 years old participants after one dose vaccination
Measured: 30 days after one dose vaccination
Safety 1
The incidence of adverse events (AEs)/vaccination-related AEs on days 0 to 30 after each dose of immunization for subjects in each age group
Measured: 30 days after each dose vaccination
Secondary outcomes (10)
Immunogenicity 4
To evaluate the positive rate of serum bactericidal activity (rSBA) antibodies against meningococcal groups A, C, Y and W135 (ratio of antibody titers ≥1:8), ratio of antibody titer ≥1:128, geometric mean growth factor (GMFI) in 3~5 months old participants after primary vaccination
Measured: 30 days after booster vaccination
Immunogenicity 5
To evaluate the serum bactericidal activity (rSBA) antibody GMT, positivity rate and rate of antibody titer ≥1:128 subjects in 3~5 months old participants before booster vaccination
Measured: Before booster vaccination
Immunogenicity 6
To evaluate the serum bactericidal activity (rSBA) antibody positive conversion rate, GMT, GMFI, positivity rate, and rate of antibody titer≥ 1:128 ratio in 3~5 months old participants after booster vaccination
Measured: 30 days after booster vaccination
Immunogenicity 7
To evaluate the positive rate of serum bactericidal activity (rSBA) antibodies against meningococcal groups A, C, Y and W135 (ratio of antibody titers ≥1:8), ratio of antibody titer ≥1:128, geometric mean growth factor (GMFI) in 6~23 months old participants after two doses vaccination
Measured: 30 days after booster vaccination
Immunogenicity 8
To evaluate the positive rate of serum bactericidal activity (rSBA) antibodies against meningococcal groups A, C, Y and W135 (ratio of antibody titers ≥1:8) and ratio of antibody titer ≥1:128 in 6~23 months old participants after vaccination
Measured: 30 days after vaccination
Immune persistence 1
To evaluate the serum bactericidal activity (rSBA) antibody positivity rate, rate of antibody titer ≥1:128 and GMT in 3~5 months old participants after booster vaccination
Measured: 6 months after booster vaccination
Immune persistence 2
To evaluate the serum bactericidal activity (rSBA) antibody positivity rate, rate of antibody titer ≥1:128 and GMT in 6~23 months old participants after two doses vaccination
Measured: 6 months, 12 months
Safety 2
AEs/vaccination-related AEs are divided into doses, severity, vaccination site and non-vaccination site, and system organs (SOC) classification and incidence of each preferred term (PT) symptom after each dose vaccination
Measured: 30 days after each dose vaccination
Safety 3
The occurrence of serious adverse events (SAE) in each group of subjects aged 3 to 5 months from the first dose vaccination to 6 months after primary vaccination and within 30 days after booster vaccination
Measured: 6 months after primary vaccination and 30 days after booster vaccination
Safety 4
The occurrence of serious adverse events (SAE) in each group of subjects aged 2~15 years and 6~23 months from the first dose vaccination to 6 months after all doses vaccination
Measured: 6 months after all doses vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2024
- Study start20 Mar 2024 (estimated)
- Primary completionJun 2024 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meningococcal MeningitisStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aimei Vacin BioPharm (Zhejiang) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ZHENG Yan, Principal investigator, YUNNAN CENTER FOR DISEASE CONROL AND PREVENTION
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06337071
- Sponsor's protocol ID
- AM2023MCV4Ⅱ
- Status last verified
- Mar 2024
- First submitted
- 13 Mar 2024
- Last updated
- 29 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Clinical Trial to Evaluate the Immunogenicity and Safety of the ACYW135 Meningococcal Polysaccharide Conjugate Vaccine in People Aged 3 Months to 15 Years Old in a Randomized, Double-blind, Parallel Controlled Design
- ClinicalTrials.gov ID
- NCT06337071
- Acronym / sponsor ID
- AM2023MCV4Ⅱ
- Conditions
- Meningococcal Meningitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Aimei Vacin BioPharm (Zhejiang) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Mar 2024 (estimated)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 29 Mar 2024 (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 purpose of this study was to explore the safety and immunogenicity of the experimental vaccine compared with the control vaccines. It is planed to enroll a total of 1,200 subjects, including 300 subjects in each of the 3-5 months old, 6-11 months old, 12-23 months old and 2-15 years old groups, who will be randomly assigned to the trial in a 1:1 ratio to study group or control group. The 3-5 month-old group will have three doses vaccination at 0, 1 and 2 month, and a booster dose at 12 months of age; the 6-11month-old and 12-23 month-old groups will each have total two doses vaccination; the 2-15 year-old group will have one dose vaccination.
Detailed description
The purpose of this study was to evaluate the safety and immunogenicity of the experimental vaccine(ACYW135 Meningococcal Polysaccharide Conjugate Vaccine) compared with the control vaccines(ACYW135 Meningococcal Polysaccharide Conjugate Vaccine and ACYW135 Meningococcal Polysaccharide Vaccine). It is planed to enroll a total of 1,200 subjects, including 300 subjects in each of the 3-5 months old, 6-11 months old, 12-23 months old and 2-15 years old groups, who will be randomly assigned to the trial in a 1:1 ratio to study group or control group. The 3-5 month-old group will have three doses vaccination at 0, 1 and 2 month, and a booster dose at 12 months of age; the 6-11month-old and 12-23 month-old groups will each have total two doses vaccination(at month 0, 1 or at month 0, 3); the 2-15 year-old group will have one dose vaccination. The immunogenicity and immune persistence will be evaluated by rabbit complement serum bactericidal assay.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Experimental Group 2~15 years | Experimental | Biological: ACYW135 Meningococcal Polysaccharide Conjugate Vaccine2~15 years old participants who vaccinated by experimental vaccine |
| Control Group 2~15 years | Active comparator | Biological: ACYW135 Meningococcal Polysaccharide Vaccine2~15 years old participants who vaccinated by control vaccine 2 |
| Experimental Group 6~23 months(0,1) | Experimental | Biological: ACYW135 Meningococcal Polysaccharide Conjugate Vaccine6~23 months old participants who vaccinated by experimental vaccine at month 0 and 1 |
| Control Group 6~23 months(0,1) | Active comparator | Biological: ACYW135 Meningococcal Polysaccharide Conjugate Vaccine6~23 months old participants who vaccinated by control vaccine 1 at month 0 and 1 |
| Experimental Group 6~23 months(0,3) | Experimental | Biological: ACYW135 Meningococcal Polysaccharide Conjugate Vaccine6~23 months old participants who vaccinated by experimental vaccine at month 0 and 3 |
| Control Group 6~23 months(0,3) | Active comparator | Biological: ACYW135 Meningococcal Polysaccharide Conjugate Vaccine6~23 months old participants who vaccinated by control vaccine 1 at month 0 and 3 |
| Experimental Group 3~5 months | Experimental | Biological: ACYW135 Meningococcal Polysaccharide Conjugate Vaccine3~5 months old participants who vaccinated by experimental vaccine at month 0, 1, 2 for primary vaccination, and vaccinated by experimental vaccine at 12-month old for booster vaccination |
| Control Group 3~5 months | Active comparator | Biological: ACYW135 Meningococcal Polysaccharide Conjugate Vaccine3~5 months old participants who vaccinated by control vaccine 1 at month 0, 1, 2 for primary vaccination, and vaccinated by control vaccine at 12-month old for booster vaccination |
Who may qualify
- Ages
- 3 months to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (14 listed)
- 3~5 months old:
- 6~23 months old:
- 2~15 years old:
Key exclusion criteria (15 listed)
- The temperature before vaccination on the day of vaccination is >37.0℃;
- Have a history of invasive disease caused by meningococci confirmed by culture;
- Have a history of severe allergic reactions that require medical intervention (such as oral and throat swelling, dyspnea, hypotension or shock caused by allergies); have a history of allergies to vaccines or vaccine components (especially those allergic to diphtheria toxoid), and have concerns about vaccination History of other serious adverse reactions;
- Those with a clearly diagnosed history of thrombocytopenia or other coagulation disorders, which may cause contraindications for intramuscular injection;
- Suffer from acute disease or acute attack of chronic disease within 3 days before vaccination;
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 |
|---|---|---|
| ACYW135 Meningococcal Polysaccharide Conjugate VaccineACYW135 Meningococcal Polysaccharide Conjugate Vaccine was produced by meningococcal polysaccharide from group A, C, Y, W135 and conjugated protein CRM197. | Biological | Control Group 3~5 months, Control Group 6~23 months(0,1), Control Group 6~23 months(0,3), Experimental Group 2~15 years, Experimental Group 3~5 months, Experimental Group 6~23 months(0,1), Experimental Group 6~23 months(0,3) |
| ACYW135 Meningococcal Polysaccharide VaccineACYW135 Meningococcal Polysaccharide Vaccine was produced by meningococcal polysaccharide from group A, C, Y, W135. | Biological | Control Group 2~15 years |
Primary outcome
Immunogenicity 1
Time frame: 30 days after primary vaccination
To evaluate the positive conversion rate and geometric mean titer (GMT) of meningococcal serum bactericidal activity (rSBA) antibodies for meningococcal groups A, C, Y, and W135 at 30 days in 3~5 months old participants after primary vaccination
Immunogenicity 2
Time frame: 30 days after two doses vaccination
To evaluate the positive conversion rate and geometric mean titer (GMT) of meningococcal serum bactericidal activity (rSBA) antibodies for meningococcal groups A, C, Y, and W135 at 30 days in 6~23 months old participants after two doses vaccination
Immunogenicity 3
Time frame: 30 days after one dose vaccination
To evaluate the positive conversion rate and geometric mean titer (GMT) of meningococcal serum bactericidal activity (rSBA) antibodies for meningococcal groups A, C, Y, and W135 at 30 days in 2~15 years old participants after one dose vaccination
Safety 1
Time frame: 30 days after each dose vaccination
The incidence of adverse events (AEs)/vaccination-related AEs on days 0 to 30 after each dose of immunization for subjects in each age group
10 secondary outcomes
Immunogenicity 4
Time frame: 30 days after booster vaccination
Immunogenicity 5
Time frame: Before booster vaccination
Immunogenicity 6
Time frame: 30 days after booster vaccination
Immunogenicity 7
Time frame: 30 days after booster vaccination
Immunogenicity 8
Time frame: 30 days after vaccination
Immune persistence 1
Time frame: 6 months after booster vaccination
Immune persistence 2
Time frame: 6 months, 12 months
Safety 2
Time frame: 30 days after each dose vaccination
Safety 3
Time frame: 6 months after primary vaccination and 30 days after booster vaccination
Safety 4
Time frame: 6 months after all doses vaccination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2024.
- Individual participant dataSharing planned: No
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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.
ZHENG Yan principal investigator
YUNNAN CENTER FOR DISEASE CONROL AND PREVENTION
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ACYW135 Meningococcal Polysaccharide Conjugate Vaccine and ACYW135 Meningococcal Polysaccharide Vaccine in people with Meningococcal Meningitis, run by Aimei Vacin BioPharm (Zhejiang) 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 14 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: status not confirmed, as of the sponsor's last update on 29 Mar 2024. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 ZHENG Yan (+8687163627796, yaqueer_zy@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immunogenicity 1 (time frame: 30 days after primary vaccination). The study lists 4 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 29 Mar 2024.