Phase Ⅲ Trial of Group ACYW135 Meningococcal Conjugate Vaccine in Children Aged 12-23 Months

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 12 to 23 Months

Overview

The goal of this clinical trial is to evaluate the immunogenicity and safety of an investigational group ACYW135 Meningococcal conjugate vaccine in healthy children aged 12 to 23 months. The main questions it aims to answer are: Is the immune response induced by the investigational vaccine non-inferior to that of the licensed control vaccine? What safety profile does the investigational vaccine have in this pediatric population? Researchers will compare the investigational vaccine group with the active comparator group (licensed ACYW135 meningococcal conjugate vaccine (CRM197 carrier), CanSinoBIO; hereinafter referred to as CanSinoBIO MCV-ACYW) to determine if the new vaccine provides comparable immune protection with an acceptable safety profile. Participants will: Receive two doses of either the investigational vaccine or the control vaccine according to a 0,1-month schedule; 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 completion of the primary immunization series; A total of 1040 participants will be enrolled and randomly assigned in a 1:1 ratio to either the investigational group or the control group.

Interventions

• Biological experimental vaccine
  Group ACYW135 Meningococcal Conjugate Vaccine
• Biological Active Comparator vaccine
  Group ACYW135 Meningococcal Conjugate Vaccine (CRM197)

Primary outcome measures

• seroconversion rates (%) of Nm antibodies for serogroups A, C, Y, W135 [Time frame: Day 30 after two-dose vaccination]
• GMTs (1:) of Nm antibodies for serogroups A, C, Y, W135 [Time frame: Day 30 after two-dose vaccination]

Secondary outcome measures (9)

• seropositive rates (%) of Nm antibodies for serogroups A, C, Y, W135 [Time frame: Day 30 after two-dose vaccination]
• GMIs (1:) of Nm antibodies for serogroups A, C, Y, W135 [Time frame: Day 30 after two-dose vaccination]
• seroconversion rates (%) and seropositive rates (%) of Nm antibodies for serogroups A, C, Y, W135 [Time frame: Day 30 after two-dose vaccination]
• GMTs (1:) of Nm antibodies for serogroups A, C, Y, W135 [Time frame: Day 30 after two-dose vaccination]
• GMIs of Nm antibodies for serogroups A, C, Y, W135 [Time frame: Day 30 after two-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 two-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 second dose]

Eligibility criteria

Inclusion criteria

• Healthy participants aged 12 to 23 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.

Exclusion criteria

• 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 Group A meningococcal polysaccharide vaccine with an interval ≤6 months since the most recent dose; prior vaccination with any other meningococcal vaccine other than Group A meningococcal polysaccharide vaccine (including but not limited to: Group A/C meningococcal polysaccharide/conjugate vaccine, ACYW135 meningococcal polysaccharide/conjugate vaccine).
• Presence of autoimmune diseases or immunodeficiency diseases (including but not limited to asplenia, functional asplenia, HIV infection in the participant or the participant's mother).
• 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 chronic diseases or history of serious illnesses, including but not limited to cardiovascular diseases, metabolic diseases, hematological diseases, hepatorenal diseases, gastrointestinal diseases, respiratory diseases, malignancies, or history of major organ transplantation.
• Severe congenital anomalies, genetic defects, or malnutrition.
• 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.
• 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 within the past 6 months, 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 chronic disease 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07505836 · PRO-ACYW-3002

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗