Meningococcal Disease; Meningococcal MeningitisPhase 4NCT07885371
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
A Phase 4 study testing MPSV-ACYW in people with Meningococcal Disease; Meningococcal Meningitis, run by Zhejiang Provincial Center for Disease Control and Prevention.
Trial summary
The sample size of this study is 200 participants, aiming to evaluate the protective effect after vaccination with quadrivalent meningococcal polysaccharide vaccine in the 13-15 age group, and to provide scientific evidence and practical guidance for meningococcal vaccination in the adolescent population. Read more about this study
- Who is it for?
- Ages 13 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Meningococcal Disease; Meningococcal Meningitis
- What is being tested?
- MPSV-ACYW
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 20 Oct 2026to 31 Dec 2027
- Phase
- Phase 4
- 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 13 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy individuals who meet the observation age range for this immunogenicity/safety study (13-15 years old) and are determined by the researchers based on their medical history.
- Obtain informed consent from the participant's guardian and have them sign the informed consent form.
- The participants and their guardians can adhere to the requirements of the clinical research protocol and persist in participating in the entire follow-up process.
- You have not received any other vaccines (including commercially available vaccines or investigational vaccines) within 30 days prior to the vaccination of the study vaccine.
- Before the age of 7, complete 4 doses of meningococcal vaccine according to the immunization program requirements (non-EPI vaccines are allowed to be used to replace corresponding doses).
Who cannot join
- Individuals who are known to be allergic to any component of this vaccine;
- Individuals who, upon evaluation by the researchers, are deemed unsuitable for participation in this study;
- Individuals with a history of vaccine or drug allergies (including but not limited to anaphylactic shock, allergic laryngeal edema, allergic purpura, and local allergic necrosis reaction (Arthus reaction)).
- Individuals with a history of epilepsy, convulsions, brain disorders, and allergies.
- People with kidney disease, heart disease, and active tuberculosis.
- Screen for individuals who have experienced fever, acute illnesses, or are in the acute phase of chronic diseases within the past three days.
About this study
The sample size of this study is 200 participants, aiming to evaluate the protective effect after vaccination with quadrivalent meningococcal polysaccharide vaccine in the 13-15 age group, and to provide scientific evidence and practical guidance for meningococcal vaccination in the adolescent population.
- Being tested
- MPSV-ACYW
- Keywords
- vaccine, vaccine preventable disease, meningococcal vaccine
- Medical subject headings
- Meningococcal Infections, Meningitis, Meningococcal, Vaccine-Preventable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MPSV-ACYWBiological
Immunogenicity and safety evaluations were conducted after administering one dose of ACYW135 meningococcal polysaccharide vaccine to 200 junior high school students aged 13-15 years.
| Study group | Role | What they receive |
|---|---|---|
| vaccination group | Experimental | Immunogenicity and safety evaluations were conducted after administering one dose of ACYW135 meningococcal polysaccharide vaccine to 200 junior high school students aged 13-15 years. Receives: Biological: MPSV-ACYW |
What is being measured
The primary outcome is the main question the study is designed to answer.
antibody seroconversion rate
The serogroup A, C, Y, and W135 meningococcal bactericidal antibody (rSBA) seroconversion rate of all participants 30 days after vaccination
Measured: From enrollment to the end of treatment at 1 year
Secondary outcomes (1)
the geometric mean titer
On the 30th day after vaccination, the geometric mean titer of serum bactericidal antibodies for the four serogroups A, C, Y, and W135
Measured: From enrollment to the end of treatment at 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study start20 Oct 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meningococcal Disease; 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 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Provincial Center for Disease Control and Prevention
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07885371
- Sponsor's protocol ID
- K-2026-057-01
- Status last verified
- Oct 2026
- First submitted
- 13 Oct 2026
- Last updated
- 21 Oct 2026
- 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 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07885371
- Acronym / sponsor ID
- K-2026-057-01
- Keywords
- vaccine, vaccine preventable disease, meningococcal vaccine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Zhejiang Provincial Center for Disease Control and PreventionOther government
- Study start
- 20 Oct 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 21 Oct 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.
The sample size of this study is 200 participants, aiming to evaluate the protective effect after vaccination with quadrivalent meningococcal polysaccharide vaccine in the 13-15 age group, and to provide scientific evidence and practical guidance for meningococcal vaccination in the adolescent population.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| vaccination group | Experimental | Biological: MPSV-ACYWImmunogenicity and safety evaluations were conducted after administering one dose of ACYW135 meningococcal polysaccharide vaccine to 200 junior high school students aged 13-15 years. |
Who may qualify
- Ages
- 13 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Healthy individuals who meet the observation age range for this immunogenicity/safety study (13-15 years old) and are determined by the researchers based on their medical history.
- Obtain informed consent from the participant's guardian and have them sign the informed consent form.
- The participants and their guardians can adhere to the requirements of the clinical research protocol and persist in participating in the entire follow-up process.
- You have not received any other vaccines (including commercially available vaccines or investigational vaccines) within 30 days prior to the vaccination of the study vaccine.
- Before the age of 7, complete 4 doses of meningococcal vaccine according to the immunization program requirements (non-EPI vaccines are allowed to be used to replace corresponding doses).
Key exclusion criteria (6 listed)
- Individuals who are known to be allergic to any component of this vaccine;
- Individuals who, upon evaluation by the researchers, are deemed unsuitable for participation in this study;
- Individuals with a history of vaccine or drug allergies (including but not limited to anaphylactic shock, allergic laryngeal edema, allergic purpura, and local allergic necrosis reaction (Arthus reaction)).
- Individuals with a history of epilepsy, convulsions, brain disorders, and allergies.
- People with kidney disease, heart disease, and active tuberculosis.
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 |
|---|---|---|
| MPSV-ACYWImmunogenicity and safety evaluations were conducted after administering one dose of ACYW135 meningococcal polysaccharide vaccine to 200 junior high school students aged 13-15 years. | Biological | vaccination group |
Primary outcome
antibody seroconversion rate
Time frame: From enrollment to the end of treatment at 1 year
The serogroup A, C, Y, and W135 meningococcal bactericidal antibody (rSBA) seroconversion rate of all participants 30 days after vaccination
1 secondary outcome
the geometric mean titer
Time frame: From enrollment to the end of treatment at 1 year
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 21 Oct 2026.
- 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.
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 4 study testing MPSV-ACYW in people with Meningococcal Disease; Meningococcal Meningitis, run by Zhejiang Provincial Center for Disease Control and Prevention.
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 6 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 21 Oct 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. 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?
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?
antibody seroconversion rate (time frame: From enrollment to the end of treatment at 1 year). 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 21 Oct 2026.