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
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