Epidemic MeningitisPhase 3NCT07505810
Phase Ⅲ Trial of Group ACYW135 Meningococcal Conjugate Vaccine in Children Aged 3-5 Months
A Phase 3 study testing experimental vaccine and Active Comparator vaccine in people with Epidemic Meningitis and Meningococcal Vaccines, run by Sinovac Biotech Co., Ltd at 2 sites in China.
Trial summary
The goal of this clinical trial is to evaluate the immunogenicity, safety, and immune persistence of the primary series of an investigational group ACYW135 meningococcal conjugate vaccine, as well as the immunogenicity and safety of a booster dose administered at 12 months of age, in healthy children aged 3 to 5… Read more about this study
- Who is it for?
- Ages 3 to 5 monthsHealthy volunteers can take part
- Conditions the study is for
- Epidemic Meningitis, Meningococcal Vaccines
- What is being tested?
- experimental vaccine and Active Comparator vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 880 participants
- Where
- 2 sitesChina
- Study dates
- 25 Mar 2026to Jan 2028
- Phase
- Phase 3
- 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 3 to 5 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy participants aged 3 to 5 months.
- The participant's legal guardian is capable of understanding and voluntarily signs the informed consent form.
- Willing and able to comply with all scheduled visits, sample collection, vaccination, and other trial procedures.
- Provision of legal identification documentation.
Who cannot join
- History (or suspected history) of meningococcal disease.
- History of infantile wheezing; history of allergy to the vaccine or any vaccine components (Group A/C/Y/W135 meningococcal capsular polysaccharide, mannitol, sucrose, sodium dihydrogen phosphate monohydrate, disodium hydrogen phosphate dodecahydrate, sodium chloride, water for injection), such as urticaria, dyspnea, angioedema; or other serious adverse reactions following prior vaccination.
- Prior vaccination with any meningococcal vaccine (including but not limited to: Group A meningococcal polysaccharide vaccine, Group A/C meningococcal polysaccharide/conjugate vaccine, ACYW135 meningococcal polysaccharide/conjugate vaccine, etc.).
- Presence of autoimmune diseases, immunodeficiency diseases (including but not limited to asplenia, functional asplenia, HIV infection in the participant or the participant's mother), current perianal abscess, or severe eczema.
- Coagulation disorders (e.g., coagulation factor deficiency, platelet abnormalities) or history of significant bleeding, hematoma, or ecchymosis following intramuscular injection or venipuncture.
- Presence of poorly controlled persistent disease conditions or history of serious illnesses, including but not limited to cardiovascular diseases, hematological diseases, hepatorenal diseases, gastrointestinal diseases, respiratory diseases, malignancies, or history of major organ transplantation.
Show all 19Show fewer
- Severe congenital anomalies, genetic defects, or malnutrition.
- Newborn gestational age <37 weeks or ≥42 weeks.
- Birth weight <2500g or >4000g, or history of difficult birth, resuscitation at birth, or neurological damage.
- Presence of or history of severe neurological disorders [epilepsy, convulsions or seizures], or family history of psychiatric disorders.
- Receipt of immunoglobulins or other blood products within the past 3 months, or planned receipt of such treatments during the study period.
- Prior receipt of immunosuppressants or other immunomodulatory therapy for ≥14 days (e.g., prednisone ≥20 mg/day or ≥2 mg/kg/day, or equivalent), cytotoxic therapy, or planned receipt of such therapies during the study period.
- Receipt of any other investigational drug or vaccine within the past 3 months, or planned receipt during the study period.
- Receipt of a live attenuated vaccine within the past 14 days, or receipt of a subunit or inactivated vaccine within the past 7 days.
- Receipt of any other licensed vaccine within the past 28 days where administration at a different injection site from the study vaccine cannot be ensured.
- Acute illness or acute exacerbation of persistent disease conditions within the past 3 days, or known or suspected active infection.
- Fever (axillary temperature >37.0°C) on the day of scheduled study vaccination, or abnormal findings on physical examination that preclude vaccination.
- Skin lesions, inflammation, ulcers, rash, or scarring at the intended injection site that may interfere with vaccination or local reaction assessment.
- Any other condition that, in the investigator's judgment, makes the participant unsuitable for participation in this clinical trial.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Guangxi Zhuang Autonomous Region Center for Disease Control and Prevention
Nanning, Guangxi, 530028
Yi Mo, 0771-2518766, moyi0415@qq.com
Yi Mo
- Recruiting
Shanxi Provincial Center for Disease Control and Prevention
Taiyuan, Shanxi, 030032
Xuefen Gao, 0351-7553916, axue721@163.com
Xuefen Gao
About this study
Official title: A Randomized, Double-Blind, Active Comparator-Controlled Phase Ⅲ Trial to Evaluate the Immunogenicity and Safety of the Group ACYW135 Meningococcal Conjugate Vaccine in Population Aged 3 to 5 Months
The goal of this clinical trial is to evaluate the immunogenicity, safety, and immune persistence of the primary series of an investigational group ACYW135 meningococcal conjugate vaccine, as well as the immunogenicity and safety of a booster dose administered at 12 months of age, in healthy children aged 3 to 5 months.
The main questions it aims to answer are:
Read more
Is the immune response induced by the primary series of the investigational vaccine non-inferior to that of the licensed control vaccine? What is the safety profile of the investigational vaccine during the primary series and booster dose? Does the investigational vaccine provide immune persistence up to 12 months of age? What is the immunogenicity of a booster dose administered at 12 months of age? Researchers will compare the investigational vaccine group with the active comparator group (CanSinoBIO MCV-ACYW) during both the primary immunization phase and the booster phase.
Participants will:
Be randomly assigned in a 1:1 ratio to receive either three doses of the investigational vaccine or three doses of the control vaccine according to a 0,1,2-month schedule during the primary immunization phase; Receive a booster dose at 12 months of age (either investigational vaccine or control vaccine according to group assignment); Provide blood samples at four time points: before primary vaccination, 30 days after primary vaccination, before booster vaccination (12 months of age), and 30 days after booster vaccination; Be observed for 30 minutes after each dose for immediate adverse reactions; Have solicited local and systemic adverse events recorded for 7 days after each dose using diary cards; Have unsolicited adverse events recorded for 30 days after each dose using diary cards; Be monitored for serious adverse events for at least 6 months after the last dose administered; A total of 880 participants will be enrolled.
- Conditions
- Epidemic Meningitis, Meningococcal Vaccines
- Being tested
- experimental vaccine, Active Comparator vaccine
- Medical subject headings
- Meningitis, Meningococcal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
experimental vaccineBiological
Group ACYW135 Meningococcal Conjugate Vaccine
Active Comparator vaccineBiological
Group ACYW135 Meningococcal Conjugate Vaccine (CRM197)
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Not described Receives: Biological: experimental vaccine |
| active comparator group | Active comparator | Not described Receives: Biological: Active Comparator vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
seroconversion rates (%) of Nm antibodies for serogroups A, C, Y, W135
seroconversion rates of Nm antibodies for serogroups A, C, Y, W135 at Day 30 after three-dose vaccination in baseline seronegative participants (pre-vaccination titer <1:8)
Measured: Day 30 after three-dose vaccination
GMTs (1:) of Nm antibodies for serogroups A, C, Y, W135
GMTs of Nm antibodies for serogroups A, C, Y, W135 at Day 30 after three-dose vaccination in baseline seronegative participants (pre-vaccination titer <1:8)
Measured: Day 30 after three-dose vaccination
Secondary outcomes (16)
seropositive rates (%) of Nm antibodies for serogroups A, C, Y, W135
seropositive rates of Nm antibodies for serogroups A, C, Y, W135 at Day 30 after three-dose vaccination in baseline seronegative participants
Measured: Day 30 after three-dose vaccination
GMIs of Nm antibodies for serogroups A, C, Y, W135
GMIs of Nm antibodies for serogroups A, C, Y, W135 at Day 30 after three-dose vaccination in baseline seronegative participants
Measured: Day 30 after three-dose vaccination
seroconversion rates (%) and seropositive rates (%) of Nm antibodies for serogroups A, C, Y, W135
seroconversion rates and seropositive rates of Nm antibodies for serogroups A, C, Y, W135 at Day 30 after three-dose vaccination in the overall study population
Measured: Day 30 after three-dose vaccination
GMTs (1:) of Nm antibodies for serogroups A, C, Y, W135
GMTs of Nm antibodies for serogroups A, C, Y, W135 at Day 30 after three-dose vaccination in the overall study population
Measured: Day 30 after three-dose vaccination
GMIs of Nm antibodies for serogroups A, C, Y, W135
GMIs of Nm antibodies for serogroups A, C, Y, W135 at Day 30 after three-dose vaccination in the overall study population
Measured: Day 30 after three-dose vaccination
proportions of participants with Nm antibody titers ≥1:16, ≥1:32, ≥1:64, and ≥1:128
proportions of participants with Nm antibody titers ≥1:16, ≥1:32, ≥1:64, and ≥1:128 for serogroups A, C, Y, and W135 at Day 30 after three-dose vaccination in baseline seronegative participants and the overall study population
Measured: Day 30 after three-dose vaccination
seropositive rates (%) of Nm antibodies for serogroups A, C, Y, W135
seropositive rates of Nm antibodies for serogroups A, C, Y, and W135 before the booster dose vaccination
Measured: before the booster dose vaccination
GMTs (1:) of Nm antibodies for serogroups A, C, Y, W135
GMTs of Nm antibodies for serogroups A, C, Y, and W135 before the booster dose vaccination
Measured: before the booster dose vaccination
proportions of participants with Nm antibody titers ≥1:16, ≥1:32, ≥1:64, and ≥1:128 for serogroups A, C, Y, and W135
proportions of participants with Nm antibody titers ≥1:16, ≥1:32, ≥1:64, and ≥1:128 for serogroups A, C, Y, and W135 before the booster dose vaccination
Measured: before the booster dose vaccination
seroconversion rates (%) and seropositive rates (%) of Nm antibodies for serogroups A, C, Y, W135
seroconversion rates and seropositive rates of Nm antibodies for serogroups A, C, Y, W135 at Day 30 after the booster dose vaccination
Measured: Day 30 after the booster dose vaccination
GMTs (1:) of Nm antibodies for serogroups A, C, Y, W135
GMTs of Nm antibodies for serogroups A, C, Y, W135 at Day 30 after the booster dose vaccination
Measured: Day 30 after the booster dose vaccination
GMIs of Nm antibodies for serogroups A, C, Y, W135
GMIs of Nm antibodies for serogroups A, C, Y, W135 at Day 30 after the booster dose vaccination
Measured: Day 30 after the booster dose vaccination
proportions of participants with Nm antibody titers ≥1:16, ≥1:32, ≥1:64, and ≥1:128 for serogroups A, C, Y, and W135
proportions of participants with Nm antibody titers ≥1:16, ≥1:32, ≥1:64, and ≥1:128 for serogroups A, C, Y, and W135 at Day 30 after the booster dose vaccination
Measured: Day 30 after the booster dose vaccination
incidence of adverse reactions/events
incidence of adverse reactions/events within 30 minutes after each dose vaccination
Measured: within 30 minutes after each dose vaccination
incidence of adverse reactions/events
incidence of adverse reactions/events within 0~30 days after each dose vaccination
Measured: within 0~30 days after each dose vaccination
incidence of serious adverse events
incidence of serious adverse events from the first dose to six months after the last dose vaccination
Measured: from the first dose to six months after the last dose vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2026
- Study start25 Mar 2026
- Primary completionApr 2027 (estimated)
- Study completionJan 2028 (estimated)
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 Sinovac Biotech Co., LtdThe 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 880 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sinovac Biotech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07505810
- Sponsor's protocol ID
- PRO-ACYW-3004
- Status last verified
- Mar 2026
- First submitted
- 13 Mar 2026
- Last updated
- 10 Aug 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 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Active Comparator-Controlled Phase Ⅲ Trial to Evaluate the Immunogenicity and Safety of the Group ACYW135 Meningococcal Conjugate Vaccine in Population Aged 3 to 5 Months
- ClinicalTrials.gov ID
- NCT07505810
- Acronym / sponsor ID
- PRO-ACYW-3004
- Conditions
- Epidemic Meningitis, Meningococcal Vaccines
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 880 participants (estimated)
- Lead sponsor
- Sinovac Biotech Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 25 Mar 2026 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 1 Apr 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 goal of this clinical trial is to evaluate the immunogenicity, safety, and immune persistence of the primary series of an investigational group ACYW135 meningococcal conjugate vaccine, as well as the immunogenicity and safety of a booster dose administered at 12 months of age, in healthy children aged 3 to 5 months.
The main questions it aims to answer are:
Is the immune response induced by the primary series of the investigational vaccine non-inferior to that of the licensed control vaccine? What is the safety profile of the investigational vaccine during the primary series and booster dose? Does the investigational vaccine provide immune persistence up to 12 months of age? What is the immunogenicity of a booster dose administered at 12 months of age? Researchers will compare the investigational vaccine group with the active comparator group (CanSinoBIO MCV-ACYW) during both the primary immunization phase and the booster phase.
Participants will:
Be randomly assigned in a 1:1 ratio to receive either three doses of the investigational vaccine or three doses of the control vaccine according to a 0,1,2-month schedule during the primary immunization phase; Receive a booster dose at 12 months of age (either investigational vaccine or control vaccine according to group assignment); Provide blood samples at four time points: before primary vaccination, 30 days after primary vaccination, before booster vaccination (12 months of age), and 30 days after booster vaccination; Be observed for 30 minutes after each dose for immediate adverse reactions; Have solicited local and systemic adverse events recorded for 7 days after each dose using diary cards; Have unsolicited adverse events recorded for 30 days after each dose using diary cards; Be monitored for serious adverse events for at least 6 months after the last dose administered; A total of 880 participants will be enrolled.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Biological: experimental vaccine |
| active comparator group | Active comparator | Biological: Active Comparator vaccine |
Who may qualify
- Ages
- 3 to 5 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Healthy participants aged 3 to 5 months.
- The participant's legal guardian is capable of understanding and voluntarily signs the informed consent form.
- Willing and able to comply with all scheduled visits, sample collection, vaccination, and other trial procedures.
- Provision of legal identification documentation.
Key exclusion criteria (19 listed)
- History (or suspected history) of meningococcal disease.
- History of infantile wheezing; history of allergy to the vaccine or any vaccine components (Group A/C/Y/W135 meningococcal capsular polysaccharide, mannitol, sucrose, sodium dihydrogen phosphate monohydrate, disodium hydrogen phosphate dodecahydrate, sodium chloride, water for injection), such as urticaria, dyspnea, angioedema; or other serious adverse reactions following prior vaccination.
- Prior vaccination with any meningococcal vaccine (including but not limited to: Group A meningococcal polysaccharide vaccine, Group A/C meningococcal polysaccharide/conjugate vaccine, ACYW135 meningococcal polysaccharide/conjugate vaccine, etc.).
- Presence of autoimmune diseases, immunodeficiency diseases (including but not limited to asplenia, functional asplenia, HIV infection in the participant or the participant's mother), current perianal abscess, or severe eczema.
- Coagulation disorders (e.g., coagulation factor deficiency, platelet abnormalities) or history of significant bleeding, hematoma, or ecchymosis following intramuscular injection or venipuncture.
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 |
|---|---|---|
| experimental vaccineGroup ACYW135 Meningococcal Conjugate Vaccine | Biological | experimental group |
| Active Comparator vaccineGroup ACYW135 Meningococcal Conjugate Vaccine (CRM197) | Biological | active comparator group |
Primary outcome
seroconversion rates (%) of Nm antibodies for serogroups A, C, Y, W135
Time frame: Day 30 after three-dose vaccination
seroconversion rates of Nm antibodies for serogroups A, C, Y, W135 at Day 30 after three-dose vaccination in baseline seronegative participants (pre-vaccination titer <1:8)
GMTs (1:) of Nm antibodies for serogroups A, C, Y, W135
Time frame: Day 30 after three-dose vaccination
GMTs of Nm antibodies for serogroups A, C, Y, W135 at Day 30 after three-dose vaccination in baseline seronegative participants (pre-vaccination titer <1:8)
16 secondary outcomes
seropositive rates (%) of Nm antibodies for serogroups A, C, Y, W135
Time frame: Day 30 after three-dose vaccination
GMIs of Nm antibodies for serogroups A, C, Y, W135
Time frame: Day 30 after three-dose vaccination
seroconversion rates (%) and seropositive rates (%) of Nm antibodies for serogroups A, C, Y, W135
Time frame: Day 30 after three-dose vaccination
GMTs (1:) of Nm antibodies for serogroups A, C, Y, W135
Time frame: Day 30 after three-dose vaccination
GMIs of Nm antibodies for serogroups A, C, Y, W135
Time frame: Day 30 after three-dose vaccination
proportions of participants with Nm antibody titers ≥1:16, ≥1:32, ≥1:64, and ≥1:128
Time frame: Day 30 after three-dose vaccination
seropositive rates (%) of Nm antibodies for serogroups A, C, Y, W135
Time frame: before the booster dose vaccination
GMTs (1:) of Nm antibodies for serogroups A, C, Y, W135
Time frame: before the booster dose vaccination
proportions of participants with Nm antibody titers ≥1:16, ≥1:32, ≥1:64, and ≥1:128 for serogroups A, C, Y, and W135
Time frame: before the booster dose vaccination
seroconversion rates (%) and seropositive rates (%) of Nm antibodies for serogroups A, C, Y, W135
Time frame: Day 30 after the booster dose vaccination
GMTs (1:) of Nm antibodies for serogroups A, C, Y, W135
Time frame: Day 30 after the booster dose vaccination
GMIs of Nm antibodies for serogroups A, C, Y, W135
Time frame: Day 30 after the booster dose vaccination
proportions of participants with Nm antibody titers ≥1:16, ≥1:32, ≥1:64, and ≥1:128 for serogroups A, C, Y, and W135
Time frame: Day 30 after the booster dose vaccination
incidence of adverse reactions/events
Time frame: within 30 minutes after each dose vaccination
incidence of adverse reactions/events
Time frame: within 0~30 days after each dose vaccination
incidence of serious adverse events
Time frame: from the first dose to six months after the last dose vaccination
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 10 Aug 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing experimental vaccine and Active Comparator vaccine in people with Epidemic Meningitis and Meningococcal Vaccines, run by Sinovac Biotech Co., Ltd at 2 sites 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 4 inclusion and 19 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: looking for participants now, as of the sponsor's last update on 10 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 2 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Contact Yi Mo (0771-2518766, cngxcdc@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
seroconversion rates (%) of Nm antibodies for serogroups A, C, Y, W135 (time frame: Day 30 after three-dose 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 10 Aug 2026.