Phase Ⅲ Trial of Group ACYW135 Meningococcal Conjugate Vaccine in Children Aged 3-5 Months

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:

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 Overview

• Status: Not yet recruiting
• Conditions: Meningococcal Vaccines; Epidemic Meningitis
• Intervention / Treatment: Biological: experimental vaccine; Biological: Active Comparator vaccine

• Study Type: Interventional
• Enrollment (Estimated): 880
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Yi Mo; Phone Number: 0771-2518766; Email: cngxcdc@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Healthy participants aged 3 to 5 months.
2. The participant's legal guardian is capable of understanding and voluntarily signs the informed consent form.
3. Willing and able to comply with all scheduled visits, sample collection, vaccination, and other trial procedures.
4. Provision of legal identification documentation.

Exclusion Criteria:

1. History (or suspected history) of meningococcal disease.
2. 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.
3. 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.).
4. 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.
5. Coagulation disorders (e.g., coagulation factor deficiency, platelet abnormalities) or history of significant bleeding, hematoma, or ecchymosis following intramuscular injection or venipuncture.
6. 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.
7. Severe congenital anomalies, genetic defects, or malnutrition.
8. Newborn gestational age <37 weeks or ≥42 weeks.
9. Birth weight <2500g or >4000g, or history of difficult birth, resuscitation at birth, or neurological damage.
10. Presence of or history of severe neurological disorders [epilepsy, convulsions or seizures], or family history of psychiatric disorders.
11. Receipt of immunoglobulins or other blood products within the past 3 months, or planned receipt of such treatments during the study period.
12. 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.
13. Receipt of any other investigational drug or vaccine within the past 3 months, or planned receipt during the study period.
14. Receipt of a live attenuated vaccine within the past 14 days, or receipt of a subunit or inactivated vaccine within the past 7 days.
15. 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.
16. Acute illness or acute exacerbation of persistent disease conditions within the past 3 days, or known or suspected active infection.
17. Fever (axillary temperature >37.0°C) on the day of scheduled study vaccination, or abnormal findings on physical examination that preclude vaccination.
18. Skin lesions, inflammation, ulcers, rash, or scarring at the intended injection site that may interfere with vaccination or local reaction assessment.
19. Any other condition that, in the investigator's judgment, makes the participant unsuitable for participation in this clinical trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: experimental group	Biological: experimental vaccine; Group ACYW135 Meningococcal Conjugate Vaccine
Active Comparator: active comparator group	Biological: Active Comparator vaccine; Group ACYW135 Meningococcal Conjugate Vaccine (CRM197)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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)	Day 30 after three-dose vaccination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of adverse reactions/events	incidence of adverse reactions/events within 30 minutes after each dose vaccination	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	within 0~30 days after each 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	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	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	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	Day 30 after the booster dose vaccination
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	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	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	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	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	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	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	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	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	before the booster dose vaccination
incidence of serious adverse events	incidence of serious adverse events from the first dose to six months after the last dose vaccination	from the first dose to six months after the last dose vaccination

Collaborators and Investigators

• Sponsor: Sinovac Biotech Co., Ltd

Study record dates

Study Major Dates

• Study Start (Estimated): March 22, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: March 13, 2026
• First Submitted That Met QC Criteria: March 29, 2026
• First Posted (Actual): April 1, 2026

Study Record Updates

• Last Update Posted (Actual): April 1, 2026
• Last Update Submitted That Met QC Criteria: March 29, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neuroinflammatory Diseases; Central Nervous System Diseases; Nervous System Diseases; Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Negative Bacterial Infections; Central Nervous System Infections; Neisseriaceae Infections; Meningitis; Meningitis, Bacterial; Central Nervous System Bacterial Infections; Meningococcal Infections; Meningitis, Meningococcal
• Other Study ID Numbers: PRO-ACYW-3004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No