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Epidemic MeningitisPhase 3NCT07505888

Phase Ⅲ Trial of Group ACYW135 Meningococcal Conjugate Vaccine in Children Aged 2-6 Years

A Phase 3 study testing experimental vaccine and active comparator vaccine in people with Epidemic Meningitis and Meningococcal Vaccines, run by Sinovac Biotech Co., Ltd at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The goal of this clinical trial is to evaluate the immunogenicity and safety of an investigational group ACYW135 meningococcal conjugate vaccine in healthy children aged 2 to 6 years. Read more about this study

Who is it for?
Ages 2 to 6 yearsHealthy volunteers can take part
Conditions the study is for
Epidemic Meningitis, Meningococcal Vaccines
What is being tested?
experimental vaccine and active comparator vaccine
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
660 participants
Where
1 siteChina
Study dates
22 Mar 2026to Nov 2026
Phase
Phase 3
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 6 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Healthy participants aged 2 to 6 years.
  • The participant's legal guardian is capable of understanding and voluntarily signs the informed consent form.
  • Willing and able to comply with all scheduled visits, sample collection, vaccination, and other trial procedures.
  • Provision of legal identification documentation.

Who cannot join

  • History (or suspected history) of meningococcal disease.
  • History of infantile wheezing/asthma; history of allergy to the vaccine or any vaccine components (Group A/C/Y/W135 meningococcal capsular polysaccharide, mannitol, sucrose, sodium dihydrogen phosphate monohydrate, disodium hydrogen phosphate dodecahydrate, sodium chloride, water for injection), such as urticaria, dyspnea, angioedema; or other serious adverse reactions following prior vaccination.
  • Prior vaccination with Group A or Group A/C meningococcal polysaccharide vaccine with an interval ≤1 year since the most recent dose; prior vaccination with any meningococcal polysaccharide/polysaccharide conjugate vaccine other than Group A or Group A/C meningococcal polysaccharide vaccines (including but not limited to: ACYW135 meningococcal polysaccharide vaccine, Group A/C meningococcal polysaccharide conjugate vaccine, ACYW135 meningococcal polysaccharide conjugate vaccine).
  • Presence of autoimmune diseases or immunodeficiency diseases (including but not limited to systemic lupus erythematosus, ankylosing spondylitis, autoimmune thyroid disease, asplenia, functional asplenia, HIV infection in the participant or the participant's mother).
  • Coagulation disorders (e.g., coagulation factor deficiency, platelet abnormalities) or history of significant bleeding, hematoma, or ecchymosis following intramuscular injection or venipuncture.
  • Presence of poorly controlled chronic diseases or history of serious illnesses, including but not limited to cardiovascular diseases, metabolic diseases, hematological diseases, hepatorenal diseases, gastrointestinal diseases, respiratory diseases, malignancies, or history of major organ transplantation.
Show all 18Show fewer
  • Severe congenital anomalies, genetic defects, or malnutrition.
  • Presence of or history of severe neurological disorders [epilepsy, convulsions or seizures (excluding history of febrile seizures)] or psychiatric disorders, or family history of psychiatric disorders.
  • Receipt of immunoglobulins or other blood products within 3 months prior to enrollment, or planned receipt of such treatments during the trial period.
  • Receipt of immunosuppressants or other immunomodulatory therapy for ≥14 days (e.g., prednisone ≥20 mg/day or ≥2 mg/kg/day, or equivalent), cytotoxic therapy within 6 months prior to enrollment, or planned receipt of such therapies during the study period.
  • Receipt of any other investigational drug or vaccine within 3 months prior to enrollment, or planned receipt during the study period.
  • Receipt of a live virus vaccine within 2 months prior to enrollment.
  • Receipt of influenza vaccine within 15 days prior to enrollment, or planned receipt of influenza vaccine within 15 days post-enrollment, or planned receipt of influenza vaccine between Days 16-28 post-enrollment at an injection site different from the study vaccine cannot be ensured.
  • Receipt of any other licensed vaccine (excluding live virus vaccines and influenza vaccine) within 1 month prior to enrollment, or planned receipt of any other licensed vaccine (excluding influenza vaccine) within 1 month post-enrollment.
  • Acute illness or acute exacerbation of chronic disease within 3 days prior to enrollment, or known or suspected active infection.
  • Fever (axillary temperature >37.0°C) on the day of scheduled study vaccination, or abnormal findings on physical examination that preclude vaccination.
  • Skin lesions, inflammation, ulcers, rash, or scarring at the intended injection site that may interfere with vaccination or local reaction assessment.
  • Any other condition that, in the investigator's judgment, makes the participant unsuitable for participation in this clinical trial.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Guangxi Zhuang Autonomous Region Center for Disease Control and Prevention

    Nanning, Guangxi, 530028

Other trials in China

About this study

Official title: A Randomized, Double-Blind, Active Comparator-Controlled Phase Ⅲ Trial to Evaluate the Immunogenicity and Safety of Group ACYW135 Meningococcal Conjugate Vaccine in Population Aged 2-6 Years

The goal of this clinical trial is to evaluate the immunogenicity and safety of an investigational group ACYW135 meningococcal conjugate vaccine in healthy children aged 2 to 6 years.

The main questions it aims to answer are:

Read more

Is the immune response induced by the investigational vaccine non-inferior to that of the licensed control vaccine, as measured by serum antibody levels? What safety profile does the investigational vaccine have in this pediatric population? Researchers will compare the investigational vaccine group with the control group (licensed ACYW135 polysaccharide vaccine) to determine if the new vaccine provides comparable immune protection with an acceptable safety profile.

Participants will:

Receive a single dose of either the investigational vaccine or the control vaccine by intramuscular injection; Provide two blood samples (before vaccination and 30 days after) for antibody testing; Have their vaccination site and overall health monitored for AE/AR immediately after injection, for 7 days and for 30 days through diary card and follow-up contacts; Be followed for serious adverse events for 6 months after vaccination. A total of 660 participants will be enrolled and randomly assigned in a 1:1 ratio to either the investigational group or the control group.

Being tested
experimental vaccine, active comparator 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.

  • experimental vaccineBiological

    group ACYW135 meningococcal conjugate vaccine

  • active comparator vaccineBiological

    group ACYW135 meningococcal polysaccharide vaccine

Study groups in NCT07505888
Study groupRoleWhat they receive
experimental groupExperimentalNot described
Receives: Biological: experimental vaccine
active comparator groupActive comparatorNot described
Receives: Biological: active comparator vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Seroconversion rates (%) of Nm antibodies for serogroups A, C, Y, W135

    seroconversion rates of Nm antibodies for serogroups A, C, Y, W135 at Day 30 after vaccination in baseline seronegative participants (pre-vaccination titer <1:8)

    Measured: Day 30 after vaccination

  2. GMTs (1:) of Nm antibodies for serogroups A, C, Y, W135

    GMTs of Nm antibodies for serogroups A, C, Y, W135 at Day 30 after vaccination in baseline seronegative participants (pre-vaccination titer <1:8)

    Measured: Day 30 after vaccination

Secondary outcomes (9)

  1. Seropositive rates (%) of Nm antibodies for serogroups A, C, Y, W135

    Seropositive rates of Nm antibodies for serogroups A, C, Y, W135 at Day 30 after vaccination in baseline seronegative participants

    Measured: Day 30 after vaccination

  2. GMIs of Nm antibodies for serogroups A, C, Y, W135

    GMIs of Nm antibodies for serogroups A, C, Y, W135 at Day 30 after vaccination in baseline seronegative participants

    Measured: Day 30 after vaccination

  3. Seroconversion rates (%) and seropositive rates (%) of Nm antibodies for serogroups A, C, Y, W135

    seroconversion rates and seropositive rates of Nm antibodies for serogroups A, C, Y, W135 at Day 30 after vaccination in the overall study population

    Measured: Day 30 after vaccination

  4. GMTs (1:) of Nm antibodies for serogroups A, C, Y, W135

    GMTs of Nm antibodies for serogroups A, C, Y, W135 at Day 30 after vaccination in the overall study population

    Measured: Day 30 after vaccination

  5. GMIs of Nm antibodies for serogroups A, C, Y, W135

    GMIs of Nm antibodies for serogroups A, C, Y, W135 at Day 30 after vaccination in the overall study population

    Measured: Day 30 after vaccination

  6. Proportions of participants with Nm antibody titers ≥1:16, ≥1:32, ≥1:64, and ≥1:128

    Proportions of participants with Nm antibody titers ≥1:16, ≥1:32, ≥1:64, and ≥1:128 for serogroups A, C, Y, and W135 at Day 30 after vaccination in baseline seronegative participants and the overall study population

    Measured: Day 30 after vaccination

  7. Incidence of adverse reactions/events

    Incidence of adverse reactions/events within 30 minutes after vaccination

    Measured: Within 30 minutes after vaccination

  8. Incidence of adverse reactions/events

    Incidence of adverse reactions/events within 0~30 days after vaccination

    Measured: 0~30 days after vaccination

  9. Incidence of serious adverse events

    Incidence of serious adverse events within six months after vaccination

    Measured: Within six months after vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Apr 2026
  2. Study start22 Mar 2026
  3. Primary completionNov 2026 (estimated)
  4. Study completionNov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
660 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07505888
Sponsor's protocol ID
PRO-ACYW-3001
Status last verified
Mar 2026
First submitted
13 Mar 2026
Last updated
10 Aug 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing experimental vaccine and active comparator vaccine in people with Epidemic Meningitis and Meningococcal Vaccines, run by Sinovac Biotech 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 18 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: under way, not looking for participants, as of the sponsor's last update on 10 Aug 2026. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

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?

Seroconversion rates (%) of Nm antibodies for serogroups A, C, Y, W135 (time frame: Day 30 after vaccination). The study lists 2 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 NCT07505888.

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 10 Aug 2026.

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