Meningococcal MeningitisPhase 1NCT07374510
Phase Ia Clinical Trial of Group ACYW135X Meningococcal Conjugate Vaccine
A Phase 1 study testing high-dose Group ACYW135X Meningococcal Conjugate Vaccine, medium-dose Group ACYW135X Meningococcal Conjugate Vaccine and low-dose Group ACYW135X Meningococcal Conjugate Vaccine in people with Meningococcal Meningitis, run by Sinovac Life Sciences Co., Ltd..
Trial summary
This trial adopts an open-label design combined with randomized, blinded, placebo-controlled and active-controlled design. The purpose of this trial is to evaluate the safety and immunogenicity of a Group ACYW135X Meningococcal Conjugate Vaccine. Read more about this study
- Who is it for?
- Ages 2 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Meningococcal Meningitis
- What is being tested?
- high-dose Group ACYW135X Meningococcal Conjugate Vaccine, medium-dose Group ACYW135X Meningococcal Conjugate Vaccine and low-dose Group ACYW135X Meningococcal Conjugate Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 21 Jan 2026to 30 Nov 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 2 to 59 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Healthy participants aged 2 to 59 years;
- The participant and/or their legal guardian can understand and voluntarily sign the informed consent form (for participants aged 8 to 17 years, the form must be signed jointly by the participant and their legal guardian);
- Be willing and able to comply with all visit schedules, sample collection procedures, vaccination protocols and other trial-related requirements, and maintain contact at any time during the study period;
- Provide valid legal identification documents of the participant and/or their legal guardian;
- Participants of childbearing potential and their sexual partners shall voluntarily adopt effective contraceptive measures from the date of signing the informed consent form until 3 months after the administration of the investigational vaccine, with no plans for sperm or egg donation during this period.
Who cannot join
- History of meningococcal disease;
- History of asthma; history of hypersensitivity to any vaccine or vaccine components (including serogroup A/C/Y/W135/X meningococcal capsular polysaccharide, mannitol, sucrose, disodium hydrogen phosphate, sodium dihydrogen phosphate, sodium chloride, and water for injection), manifested as symptoms such as urticaria, dyspnea, or angioedema; or history of other severe adverse reactions following previous vaccination;
- For children aged 2 to 6 years: history of previous vaccination with group ACYW135 meningococcal polysaccharide vaccine; or history of previous vaccination with any meningococcal conjugate vaccine other than group AC meningococcal conjugate vaccine; an interval of ≤ 12 months from the last dose of group A or group AC meningococcal polysaccharide vaccine or group AC meningococcal conjugate vaccine; history of vaccination with meningococcal conjugate vaccine since reaching 1 year of age. No vaccination history restrictions apply to participants aged 7 to 59 years;
- Presence of autoimmune diseases or immunodeficiency diseases (including but not limited to systemic lupus erythematosus, ankylosing spondylitis, autoimmune thyroid diseases, asplenia, functional asplenia, and HIV infection);
- Presence of coagulation disorders (e.g., coagulation factor deficiency, thrombocytopathy), or a history of significant bleeding, hematoma, or ecchymosis following previous intramuscular injection or venipuncture;
- History of severe diseases or current diagnosis of severe chronic diseases (including but not limited to severe cardiovascular diseases, uncontrolled hypertension, hematological diseases, hepatic and renal diseases, gastrointestinal diseases, respiratory diseases, malignant tumors, and history of major organ transplantation);
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- Presence of severe congenital malformations, genetic defects, or malnutrition;
- Presence or history of severe neurological diseases (epilepsy, convulsions, or seizures) or psychiatric disorders, or a family history of psychiatric disorders;
- Chronic alcohol abuse [weekly alcohol consumption > 14 standard drinks (1 standard drink = 14 grams of 100% alcohol ≈ 360 mL beer, 150 mL wine, or 45 mL distilled spirits/liquor)] or a history of substance abuse (repeated and excessive use of narcotic drugs, psychotropic drugs, volatile organic solvents, etc.);
- Receipt of immunosuppressive therapy or other immunomodulatory therapy for ≥ 14 days within the past 6 months (prednisone ≥ 20 mg/day or ≥ 2 mg/kg/day, or its equivalent dose); receipt of cytotoxic therapy; or planned receipt of such therapies during the study period;
- Receipt of blood products within 3 months prior to the administration of the investigational vaccine;
- Receipt of other investigational drugs or vaccines within 3 months prior to the administration of the investigational vaccine, or planned receipt of such drugs or vaccines during the study period;
- Receipt of live attenuated vaccines or nucleic acid vaccines within the past 14 days, or receipt of subunit vaccines or inactivated vaccines within the past 7 days;
- Participants who are breastfeeding, pregnant, or planning to become pregnant within 3 months after vaccination in this trial;
- Presence of any acute diseases or acute exacerbation of chronic diseases within the past 7 days, or known or suspected active infections;
- Clinically significant abnormal findings in laboratory tests：
- Hematological parameters: white blood cell count, hemoglobin, platelet count;
- Biochemical parameters: alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin (TBIL), blood glucose;
- Urinalysis parameters: urine protein (PRO);
- Axillary temperature > 37.0℃ prior to vaccination, or other vital sign measurements beyond the reference range;
- Presence of skin damage, inflammation, ulceration, rash, or scarring at the intended injection site that may interfere with vaccination or observation of local reactions;
- Any other factors that, in the investigator's judgment, render the participant unsuitable for participation in this clinical trial.
About this study
Official title: An Open-Label Combined Randomized, Blinded, Placebo- and Active-Controlled Phase Ia Clinical Trial: Evaluate the Safety and Immunogenicity of the Group ACYW135X Meningococcal Conjugate Vaccine in Individuals Aged 2 to 59 Years
This trial adopts an open-label design combined with randomized, blinded, placebo-controlled and active-controlled design. The purpose of this trial is to evaluate the safety and immunogenicity of a Group ACYW135X Meningococcal Conjugate Vaccine. This study is planned to enroll 150 participants in total, with healthy individuals aged 2 to 59 years as participants. Among them, participants aged 18 to 59 years and 7 to 17 years will be assigned to the open-label design arm, while participants aged 4 to 6 years will be assigned to the randomized, blinded, placebo-controlled design arms.
- Conditions
- Meningococcal Meningitis
- Being tested
- high-dose Group ACYW135X Meningococcal Conjugate Vaccine, medium-dose Group ACYW135X Meningococcal Conjugate Vaccine, low-dose Group ACYW135X Meningococcal Conjugate Vaccine, Group ACYW135 Meningococcal Conjugate Vaccine (CRM197), Placebo
- Keywords
- ACYW135X, vaccine, phase 1
- Medical subject headings
- Meningitis, Meningococcal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high-dose Group ACYW135X Meningococcal Conjugate VaccineBiological
high-dose Group ACYW135X Meningococcal Conjugate Vaccine
medium-dose Group ACYW135X Meningococcal Conjugate VaccineBiological
medium-dose Group ACYW135X Meningococcal Conjugate Vaccine
low-dose Group ACYW135X Meningococcal Conjugate VaccineBiological
low-dose Group ACYW135X Meningococcal Conjugate Vaccine
Group ACYW135 Meningococcal Conjugate Vaccine (CRM197)Biological
Also called Menhycia
Group ACYW135 Meningococcal Conjugate Vaccine (CRM197)
PlaceboBiological
placebo
| Study group | Role | What they receive |
|---|---|---|
| high-dose experimental group | Experimental | 2~59 years old Receives: Biological: high-dose Group ACYW135X Meningococcal Conjugate Vaccine |
| medium-dose experimental group | Experimental | 2~59 years old Receives: Biological: medium-dose Group ACYW135X Meningococcal Conjugate Vaccine |
| low-dose experimental group | Experimental | 2~6 years old Receives: Biological: low-dose Group ACYW135X Meningococcal Conjugate Vaccine |
| placebo group | Placebo comparator | 2~6 years old Receives: Biological: Placebo |
| active control group | Active comparator | 2~3 years old Receives: Biological: Group ACYW135 Meningococcal Conjugate Vaccine (CRM197) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the safety of experimental vaccine among participants in different age groups (based on adverse reactions)
The incidence rates of adverse reactions 30 days after vaccination
Measured: 30 days
Secondary outcomes (5)
Evaluate the safety of experimental vaccine among participants in different age groups (based on AE and laboratory abnormalities)
The incidence rate of adverse events 30 days after vaccination
Measured: 30 days
Evaluate the safety of experimental vaccine among participants in different age groups (based on AE and laboratory abnormalities)
The incidence rate of clinically significant abnormal blood biochemistry, blood routine, and urine routine indexes within 3 days after vaccination
Measured: 3 days
Evaluate the safety of experimental vaccine among participants in different age groups (based on AE and laboratory abnormalities)
The incidence rate of serious adverse events 6 months after vaccination
Measured: 6 months
Evaluate the immunogenicity of experimental vaccine among participants aged 2~6 years old
The seropositive rates, seroconversion rate, GMT and GMFR of Nm antibody against serogroups A, C, Y, W135, and X at 30 days after vaccination
Measured: 30 days
Evaluate the immunogenicity of experimental vaccine among participants aged 2~6 years old
The proportion of Nm antibody against serogroups A, C, Y, W135, and X with titer ≥ 1:16, ≥ 1:32, ≥ 1:64, and ≥ 1:128 at 30 days after vaccination
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study start21 Jan 2026 (estimated)
- Primary completion10 Sep 2026 (estimated)
- Study completion30 Nov 2026 (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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sinovac Life Sciences Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07374510
- Sponsor's protocol ID
- PRO-ACYWX-1001
- Status last verified
- Jan 2026
- First submitted
- 20 Jan 2026
- Last updated
- 28 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Combined Randomized, Blinded, Placebo- and Active-Controlled Phase Ia Clinical Trial: Evaluate the Safety and Immunogenicity of the Group ACYW135X Meningococcal Conjugate Vaccine in Individuals Aged 2 to 59 Years
- ClinicalTrials.gov ID
- NCT07374510
- Acronym / sponsor ID
- PRO-ACYWX-1001
- Conditions
- Meningococcal Meningitis
- Keywords
- ACYW135X, vaccine, phase 1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Sinovac Life Sciences Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 21 Jan 2026 (estimated)
- Primary completion
- 10 Sep 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 28 Jan 2026 (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 trial adopts an open-label design combined with randomized, blinded, placebo-controlled and active-controlled design. The purpose of this trial is to evaluate the safety and immunogenicity of a Group ACYW135X Meningococcal Conjugate Vaccine. This study is planned to enroll 150 participants in total, with healthy individuals aged 2 to 59 years as participants. Among them, participants aged 18 to 59 years and 7 to 17 years will be assigned to the open-label design arm, while participants aged 4 to 6 years will be assigned to the randomized, blinded, placebo-controlled design arms.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| high-dose experimental group | Experimental | Biological: high-dose Group ACYW135X Meningococcal Conjugate Vaccine2~59 years old |
| medium-dose experimental group | Experimental | Biological: medium-dose Group ACYW135X Meningococcal Conjugate Vaccine2~59 years old |
| low-dose experimental group | Experimental | Biological: low-dose Group ACYW135X Meningococcal Conjugate Vaccine2~6 years old |
| placebo group | Placebo comparator | Biological: Placebo2~6 years old |
| active control group | Active comparator | Biological: Group ACYW135 Meningococcal Conjugate Vaccine (CRM197)2~3 years old |
Who may qualify
- Ages
- 2 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Healthy participants aged 2 to 59 years;
- The participant and/or their legal guardian can understand and voluntarily sign the informed consent form (for participants aged 8 to 17 years, the form must be signed jointly by the participant and their legal guardian);
- Be willing and able to comply with all visit schedules, sample collection procedures, vaccination protocols and other trial-related requirements, and maintain contact at any time during the study period;
- Provide valid legal identification documents of the participant and/or their legal guardian;
- Participants of childbearing potential and their sexual partners shall voluntarily adopt effective contraceptive measures from the date of signing the informed consent form until 3 months after the administration of the investigational vaccine, with no plans for sperm or egg donation during this period.
Key exclusion criteria (22 listed)
- History of meningococcal disease;
- History of asthma; history of hypersensitivity to any vaccine or vaccine components (including serogroup A/C/Y/W135/X meningococcal capsular polysaccharide, mannitol, sucrose, disodium hydrogen phosphate, sodium dihydrogen phosphate, sodium chloride, and water for injection), manifested as symptoms such as urticaria, dyspnea, or angioedema; or history of other severe adverse reactions following previous vaccination;
- For children aged 2 to 6 years: history of previous vaccination with group ACYW135 meningococcal polysaccharide vaccine; or history of previous vaccination with any meningococcal conjugate vaccine other than group AC meningococcal conjugate vaccine; an interval of ≤ 12 months from the last dose of group A or group AC meningococcal polysaccharide vaccine or group AC meningococcal conjugate vaccine; history of vaccination with meningococcal conjugate vaccine since reaching 1 year of age. No vaccination history restrictions apply to participants aged 7 to 59 years;
- Presence of autoimmune diseases or immunodeficiency diseases (including but not limited to systemic lupus erythematosus, ankylosing spondylitis, autoimmune thyroid diseases, asplenia, functional asplenia, and HIV infection);
- Presence of coagulation disorders (e.g., coagulation factor deficiency, thrombocytopathy), or a history of significant bleeding, hematoma, or ecchymosis following previous intramuscular injection or venipuncture;
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 |
|---|---|---|
| high-dose Group ACYW135X Meningococcal Conjugate Vaccinehigh-dose Group ACYW135X Meningococcal Conjugate Vaccine | Biological | high-dose experimental group |
| medium-dose Group ACYW135X Meningococcal Conjugate Vaccinemedium-dose Group ACYW135X Meningococcal Conjugate Vaccine | Biological | medium-dose experimental group |
| low-dose Group ACYW135X Meningococcal Conjugate Vaccinelow-dose Group ACYW135X Meningococcal Conjugate Vaccine | Biological | low-dose experimental group |
| Group ACYW135 Meningococcal Conjugate Vaccine (CRM197)Also: MenhyciaGroup ACYW135 Meningococcal Conjugate Vaccine (CRM197) | Biological | active control group |
| Placeboplacebo | Biological | placebo group |
Primary outcome
Evaluate the safety of experimental vaccine among participants in different age groups (based on adverse reactions)
Time frame: 30 days
The incidence rates of adverse reactions 30 days after vaccination
5 secondary outcomes
Evaluate the safety of experimental vaccine among participants in different age groups (based on AE and laboratory abnormalities)
Time frame: 30 days
Evaluate the safety of experimental vaccine among participants in different age groups (based on AE and laboratory abnormalities)
Time frame: 3 days
Evaluate the safety of experimental vaccine among participants in different age groups (based on AE and laboratory abnormalities)
Time frame: 6 months
Evaluate the immunogenicity of experimental vaccine among participants aged 2~6 years old
Time frame: 30 days
Evaluate the immunogenicity of experimental vaccine among participants aged 2~6 years old
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
Related trials for Meningococcal Meningitis
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Single-center, Open-label Study: Immunogenicity and Safety Observation After Vaccination With ACYW135 Meningococcal Polysaccharide Vaccine in Junior High School Students Aged 13-15 Years
Meningococcal Disease; Meningococcal Meningitis
Active, not recruitingPhase 2
Safety, Tolerability, and Immunogenicity of MenABCWY Administered on Different Dosing Schedules in Healthy Adolescents
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RecruitingPhase 3
Phase Ⅲ Trial of Group ACYW135 Meningococcal Conjugate Vaccine in Children Aged 3-5 Months
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Phase Ⅲ Trial of Group ACYW135 Meningococcal Conjugate Vaccine in Children Aged 2-6 Years
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing high-dose Group ACYW135X Meningococcal Conjugate Vaccine, medium-dose Group ACYW135X Meningococcal Conjugate Vaccine and low-dose Group ACYW135X Meningococcal Conjugate Vaccine in people with Meningococcal Meningitis, run by Sinovac Life Sciences 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 5 inclusion and 22 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: opening soon, as of the sponsor's last update on 28 Jan 2026. 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 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?
This study is still under way. Results are not available in the source record yet.
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?
Evaluate the safety of experimental vaccine among participants in different age groups (based on adverse reactions) (time frame: 30 days). 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 28 Jan 2026.