Epidemic MeningitisPhase 4NCT06389513
Clinical Study of the Safety of Menhycia® in 3-Month-Old Infants
A Phase 4 study testing MCV4 in people with Epidemic Meningitis, run by CanSino Biologics Inc. at 1 site in China.
Trial summary
This study is an open, multicenter Phase IV clinical study to evaluate the safety of vaccination with Menhycia®. The study plan is to enroll approximately 3,000 infants at 3 months of age who have not been vaccinated with any epidemic encephalitis vaccine, and to administer a total of 3 doses of Menhycia®, with a… Read more about this study
- Who is it for?
- Ages 3 to 3 monthsHealthy volunteers can take part
- Conditions the study is for
- Epidemic Meningitis
- What is being tested?
- MCV4
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,011 participants
- Where
- 1 siteChina
- Study dates
- 12 Jun 2024to 1 May 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 3 to 3 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Infants 3 months of age who had not received any epidemic encephalitis vaccine at the time of screening
- The legal guardian or delegate has given informed consent, has voluntarily signed an informed consent form, and is able to comply with the requirements of the clinical study protocol
Who cannot join
- First dose exclusion criteria
- Fever before vaccination, axillary temperature >37.0°C
- Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.
- History of epilepsy, convulsions or seizures or history or family history of psychiatric disorders
- Acute infections or active chronic diseases, severe infectious or allergic skin diseases
- Known allergy to a component of the vaccine, especially to diphtheria toxoid, or to previous administration of the product
Show all 11Show fewer
- Other circumstances that, in the judgment of the investigator, make participation in this clinical study inappropriate
- Subsequent dose exclusion criteria
- Severe allergic reactions after a previous dose of vaccine
- Those with serious adverse reactions causally related to the previous dose of vaccination
- Other circumstances that, in the judgment of the investigator, make participation in this clinical study inappropriate
Trial locations and contacts
1 site in 1 country.
China1 site
Nanjing Luhe District Center for Disease Control and Prevention Center for Disease Control and Prevention
Nanjing
About this study
Official title: Phase IV Clinical Study of the Safety of Menhycia® in 3-Month-Old Infants
This study is an open, multicenter Phase IV clinical study to evaluate the safety of vaccination with Menhycia®. The study plan is to enroll approximately 3,000 infants at 3 months of age who have not been vaccinated with any epidemic encephalitis vaccine, and to administer a total of 3 doses of Menhycia®, with a minimum of 1 month between doses, and a booster dose of 1 dose of immunization is allowed at 12 months of age.
- Conditions
- Epidemic Meningitis
- Being tested
- MCV4
- Keywords
- Vaccine, ACYW135, CRM197, Safety, 3 months of age
- 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
4 doses of vaccine on Day 0, Day30, Day 60 and Month 12
| Study group | Role | What they receive |
|---|---|---|
| ACYW135 Group Meningococcal Polysaccharide Conjugate Vaccine (CRM197) (MCV4) | Experimental | Intramuscular injection, 0.5ml Receives: Biological: MCV4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of localized adverse reactions in subjects
Measured: Within 7 days after each dose of vaccination
Incidence of systemic adverse reactions in subjects
Measured: Within 7 days after each dose of vaccination
Secondary outcomes (3)
Incidence of adverse reactions in subjects
Measured: Within 30 days after each dose of vaccination
Incidence of adverse events in subjects
Measured: Within 30 days after each dose of vaccination
Incidence of severe adverse events
Measured: Through study completion, an average of 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start12 Jun 2024
- Primary completion10 Apr 2026
- Study completion1 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epidemic MeningitisStudies of the same condition, open and under way.
- More trials run by CanSino Biologics Inc.The sponsor's other registered studies.
- 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
- 3,011 participants (actual)
Sponsor and investigators
- Lead sponsor
- CanSino Biologics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06389513
- Sponsor's protocol ID
- CTP-MCVF-005
- Status last verified
- Aug 2025
- First submitted
- 24 Apr 2024
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV Clinical Study of the Safety of Menhycia® in 3-Month-Old Infants
- ClinicalTrials.gov ID
- NCT06389513
- Acronym / sponsor ID
- CTP-MCVF-005
- Conditions
- Epidemic Meningitis
- Keywords
- Vaccine, ACYW135, CRM197, Safety, 3 months of age
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,011 participants (actual)
- Lead sponsor
- CanSino Biologics Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Jun 2024 (actual)
- Primary completion
- 10 Apr 2026 (actual)
- Study completion
- 1 May 2026 (actual)
- First posted
- 29 Apr 2024 (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.
This study is an open, multicenter Phase IV clinical study to evaluate the safety of vaccination with Menhycia®. The study plan is to enroll approximately 3,000 infants at 3 months of age who have not been vaccinated with any epidemic encephalitis vaccine, and to administer a total of 3 doses of Menhycia®, with a minimum of 1 month between doses, and a booster dose of 1 dose of immunization is allowed at 12 months of age.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ACYW135 Group Meningococcal Polysaccharide Conjugate Vaccine (CRM197) (MCV4) | Experimental | Biological: MCV4Intramuscular injection, 0.5ml |
Who may qualify
- Ages
- 3 to 3 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Infants 3 months of age who had not received any epidemic encephalitis vaccine at the time of screening
- The legal guardian or delegate has given informed consent, has voluntarily signed an informed consent form, and is able to comply with the requirements of the clinical study protocol
Key exclusion criteria (11 listed)
- First dose exclusion criteria
- Fever before vaccination, axillary temperature >37.0°C
- Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.
- History of epilepsy, convulsions or seizures or history or family history of psychiatric disorders
- Acute infections or active chronic diseases, severe infectious or allergic skin diseases
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 |
|---|---|---|
| MCV44 doses of vaccine on Day 0, Day30, Day 60 and Month 12 | Biological | ACYW135 Group Meningococcal Polysaccharide Conjugate Vaccine (CRM197) (MCV4) |
Primary outcome
Incidence of localized adverse reactions in subjects
Time frame: Within 7 days after each dose of vaccination
Incidence of systemic adverse reactions in subjects
Time frame: Within 7 days after each dose of vaccination
3 secondary outcomes
Incidence of adverse reactions in subjects
Time frame: Within 30 days after each dose of vaccination
Incidence of adverse events in subjects
Time frame: Within 30 days after each dose of vaccination
Incidence of severe adverse events
Time frame: Through study completion, an average of 10 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
Related trials for Epidemic Meningitis
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Safety, Tolerability, and Immunogenicity of MenABCWY Administered on Different Dosing Schedules in Healthy Adolescents
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Phase Ⅲ Trial of Group ACYW135 Meningococcal Conjugate Vaccine in Children Aged 3-5 Months
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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 2 inclusion and 11 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: finished, as of the sponsor's last update on 13 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of localized adverse reactions in subjects (time frame: Within 7 days after each dose of 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?
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 13 Aug 2026.