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

NCT07505810 | Not Yet Recruiting Phase 3

• 1 other identifier: PRO-ACYW-3004
• Study Type: interventional
• Target: 880
• Locations: 0 countries
• Sites: N/A

Brief 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 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.

Conditions

Epidemic Meningitis; Meningococcal Vaccines

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (16)

• seropositive rates (%) of Nm antibodies for serogroups A, C, Y, W135

  Day 30 after three-dose vaccination

• GMIs of Nm antibodies for serogroups A, C, Y, W135

  Day 30 after three-dose vaccination

• seroconversion rates (%) and seropositive rates (%) of Nm antibodies for serogroups A, C, Y, W135

  Day 30 after three-dose vaccination

• GMTs (1:) of Nm antibodies for serogroups A, C, Y, W135

  Day 30 after three-dose vaccination

• GMIs of Nm antibodies for serogroups A, C, Y, W135

  Day 30 after three-dose vaccination

Study Arms (2)

experimental group

EXPERIMENTAL

Biological: experimental vaccine

active comparator group

ACTIVE COMPARATOR

Biological: Active Comparator vaccine

Interventions

experimental vaccine BIOLOGICAL

Group ACYW135 Meningococcal Conjugate Vaccine

experimental group

Active Comparator vaccine BIOLOGICAL

Group ACYW135 Meningococcal Conjugate Vaccine (CRM197)

active comparator group

Eligibility Criteria

• Age: 3 Months - 5 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Sinovac Biotech Co., Ltd: lead

MeSH Terms

Conditions

Meningitis, Meningococcal

Condition Hierarchy (Ancestors)

Meningitis, Bacterial; Central Nervous System Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Meningococcal Infections; Neisseriaceae Infections; Gram-Negative Bacterial Infections; Central Nervous System Infections; Central Nervous System Diseases; Nervous System Diseases; Meningitis; Neuroinflammatory Diseases

Central Study Contacts

Yi Mo

CONTACT

0771-2518766; cngxcdc@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2026
• First Posted: April 1, 2026
• Study Start: March 22, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share