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Epidemic MeningitisPhase 4NCT05935176

Phase IV Clinical Study of Immunogenicity of ACYW135 Group Meningococcal Polysaccharide Conjugate Vaccine (CRM197 Vector)

A Phase 4 study testing MCV4 in people with Epidemic Meningitis, run by CanSino Biologics Inc. 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 purpose of this clinical study is to evaluate the immunogenicity and immunopersistence of the ACYW135 meningococcal polysaccharide conjugate vaccine (CRM197 vector).The protocol consists of two parts: Part 1 enrolled 660 eligible participants aged 6 to 23 months, which has now been completed. Read more about this study

Who is it for?
Ages 6 to 23 monthsHealthy volunteers can take part
Conditions the study is for
Epidemic Meningitis
What is being tested?
MCV4
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
20 Sep 2023to 15 Jul 2026
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 6 to 23 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Children aged 6 to 23 months at the time of screening
  • Volunteers who have not received any vaccine containing a epidemic encephalitis component or who have received only the group A polysaccharide flu vaccine and have been vaccinated more than 6 months since their last vaccination. 6 months or more between the last vaccination and the last vaccination
  • The legal guardian or delegate has given informed consent, voluntarily signed the informed consent form, and is able to comply with the requirements of the clinical study protocol
  • The first phase of the study has been completed, involving the (0, 3) month vaccination schedule group for subjects aged 6 to 11 months. All subjects received two doses as required, and blood samples were collected 30 days after the primary vaccination series.
  • Children aged 3 years at the time of screening
  • The trial participant is able and willing to comply with the requirements of the clinical trial protocol and can complete the 1-month study follow-up.
  • The trial participants did not receive any meningococcal vaccine booster doses at age 3 years
  • The legal guardian or authorized representative voluntarily signs the informed consent form with full knowledge and understanding, and is able to comply with the requirements of the clinical research protocol.

Who cannot join

  • Fever before inoculation, axillary temperature >37.0℃
  • History of epilepsy, convulsions or seizures or history of psychiatric disorders or family history
  • During an acute illness episode; with a serious chronic illness or a condition that is in a progressive stage that cannot be smoothly controlled (or an acute episode)
  • Known allergy to a component of the vaccine, especially to diphtheria toxoid
  • Live attenuated vaccine received within 14 days or other vaccine received within 7 days prior to enrollment
  • Other circumstances that, in the judgment of the investigator, make participation in this clinical study inappropriate
Show all 16Show fewer
  • Those who had a severe allergic reaction after the previous dose of vaccine
  • Those with serious adverse reactions causally related to the previous dose of vaccination
  • Newly identified or newly occurred cases after the first vaccination that do not meet the inclusion criteria for the first dose or meet the exclusion criteria for the first dose will be determined by the investigator whether to continue to participate in the study
  • Part Ⅱ
  • Fever prior to vaccination, with axillary temperature >37.0°C
  • History of epilepsy, convulsions, or seizures; psychiatric history or family history of psychiatric disorders
  • During acute phase of illness; severe chronic disease or progressive condition not well controlled (or in acute phase)
  • Known allergy to any vaccine component, particularly diphtheria toxoid
  • Receipt of live attenuated vaccines within 14 days or other vaccines within 7 days prior to enrollment
  • Other conditions deemed ineligible for this clinical study by the investigator

Trial locations and contacts

1 site in 1 country.

China1 site

  • Wuzhi County Center for Disease Control and Prevention

    Jiaozuo, Henan

Other trials in China

About this study

Official title: Phase IV Clinical Trial of Immunogenicity of ACYW135 Meningococcal Polysaccharide Conjugate Vaccine (CRM197 Vector) in a Population Aged 6 to 23 Months

The purpose of this clinical study is to evaluate the immunogenicity and immunopersistence of the ACYW135 meningococcal polysaccharide conjugate vaccine (CRM197 vector).The protocol consists of two parts: Part 1 enrolled 660 eligible participants aged 6 to 23 months, which has now been completed. Part 2 : Open Clinical Researchplans to enroll approximately 100 eligible participants from Part 1 who have completed immunopreservance blood sampling. Participants will receive a single booster dose of the ACYW135 group meningococcal polysaccharide conjugate vaccine (CRM197 vector) at age 3 years (but not yet 4 years).

Read the detailed description

Meningococci are divided into 12 serogroups, and 95% of meningococcal cases are caused by serogroups A, B, C, X, W, and Y. Meningococcal epidemic flora can change, and the reasons are related to various factors such as meningococcal strain variation, human mobility transmission, and vaccination against different serogroups of meningococci, etc. The emergence of new serogroups of meningococci can cause the original vaccine to lose its immune protective efficacy and require a new vaccine immunization prevention strategy. the ACYW135 group meningococcal polysaccharide conjugate vaccine was approved in 2016 for a whole population The vaccine has been approved by the State Drug Administration for the prevention of epidemic meningoencephalitis caused by meningococci of groups A, C, W135 and Y in children from 3 months to 3 years of age (47 months of age).

Being tested
MCV4
Keywords
ACYW135, CRM197, Immunogenicity, Persistence, 6~23 months of age, 3 years old
Medical subject headings
Meningitis, Meningococcal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MCV4Biological

    2 dose of MCV4 on Day 0 and Month 1

  • MCV4Biological

    2 dose of MCV4 on Day 0 and Month 3

  • MCV4Biological

    1 booster dose of MCV4 at 3 years old

Study groups in NCT05935176
Study groupRoleWhat they receive
Part Ⅰ: Vaccine Group AExperimental2 dose of ACYW135 group meningococcal polysaccharide conjugate vaccine(MCV4) (0.5ml)
Receives: Biological: MCV4
PartⅠ: Vaccine Group BExperimental2 dose of MCV4 (0.5ml)
Receives: Biological: MCV4
Part Ⅱ: Vaccine Group CExperimental1 dose of MCV4 (0.5ml) at 3 years old from group B in Part I
Receives: Biological: MCV4

What is being measured

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

  1. Antibody positivity for A, C, Y and W135 in all subjects 6 months after 2 dose exemption

    Measured: 6 months after 2 dose exemption

  2. Seroconversion rates for serotypes A, C, Y, and W135

    Measured: 30 days post-booster vaccination

  3. Geometric mean titers (GMTs) for serotypes A, C, Y, and W135

    Measured: 30 days post-booster vaccination

  4. Increased incidence of adverse reactions

    Measured: Within 7 days after post-booster vaccination

Secondary outcomes (7)

  1. Antibody positivity for A, C, Y and W135 in all subjects 9 months after 2 dose exemption

    Measured: 9 months after 2 dose exemption

  2. A, C, Y and W135 antibody positive conversion rate, positivity rate, GMT, GMI, ≥1:128 ratio in all subjects at 30 days after dose 2 exemption

    Measured: 30 days after dose 2 exemption

  3. A, C, Y and W135 antibody GMT, GMI, ≥1:128 ratio in all subjects at 6 and 9 months after 2 dose exemption

    Measured: 6 and 9 months after 2 dose exemption

  4. A, C, Y and W135 antibody GMT, positivity rate, GMI 30 days, 60 days after the first dose, and before the second dose in some subjects of the (0, 3) month immunization program

    Measured: 30 days , 60 days after the first dose, and before the second dose

  5. Increased incidence of adverse events

    Measured: Within 7 days after post-booster vaccination

  6. Increased Incidence of adverse reactions/events

    Measured: Within 30 days after post-booster vaccination

  7. A, C, Y, and W135 Antibody Positivity Rates and GMI and ≥1:128 Proportions

    Measured: Within 30 days after post-booster vaccination

Timeline

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

  1. First posted7 Jul 2023
  2. Study start20 Sep 2023
  3. Primary completion15 May 2026 (estimated)
  4. Study completion15 Jul 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 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
660 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05935176
Sponsor's protocol ID
CTP-MCVF-004
Status last verified
Mar 2026
First submitted
27 Jun 2023
Last updated
4 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing MCV4 in people with Epidemic Meningitis, run by CanSino Biologics Inc. 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 8 inclusion and 16 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 4 Mar 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 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 positivity for A, C, Y and W135 in all subjects 6 months after 2 dose exemption (time frame: 6 months after 2 dose exemption). The study lists 4 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 NCT05935176.

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 4 Mar 2026.

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