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Not yet recruitingNCT07885371Updated Oct 21, 2026

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 interventional study of MPSV-ACYW in Meningococcal Disease; Meningococcal Meningitis, sponsored by Zhejiang Provincial Center for Disease Control and Prevention. Not yet recruiting. Open to participants aged 13 Years to 15 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-21.

Sponsored by Zhejiang Provincial Center for Disease Control and Prevention · Phase 4, Interventional, and Prevention

Updated Oct 21, 2026Newly registeredGo to Updates ↓
Phase
Phase 4
Study type
Interventional
Enrollment
200
Allocation
Not applicable
Ages
13 Years to 15 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Meningococcal Disease; Meningococcal Meningitis

Keywords

  • vaccine
  • vaccine preventable disease
  • meningococcal vaccine
03

In context

Meningococcal Infections

225 studies on the registry are indexed under Meningococcal Infections; 8 are open to participants now.

This study's planned enrollment of 200 is below the median of 447 across 195 interventional studies indexed under Meningococcal Infections.

Browse Meningococcal Infections studies →

Lead sponsor

Zhejiang Provincial Center for Disease Control and Prevention is the lead sponsor of 13 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
13 Years to 15 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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).

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    vaccination group

    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.

    Biological: MPSV-ACYW

Interventions

  • BiologicalMPSV-ACYW

    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.

06

What researchers measure

Primary outcomes

  1. antibody seroconversion rate

    The serogroup A, C, Y, and W135 meningococcal bactericidal antibody (rSBA) seroconversion rate of all participants 30 days after vaccination

    Time frame: 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

    Time frame: From enrollment to the end of treatment at 1 year

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 21, 2026
Show all 1 update
  1. Oct 21, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07885371
Lead sponsor
Zhejiang Provincial Center for Disease Control and Prevention
Responsible party
Sponsor
First posted
Oct 21, 2026
Start date
Oct 20, 2026 (estimated)
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Oct 21, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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