A Study of the ACYW135 Meningococcal Polysaccharide Conjugate Vaccine

NCT06337071 | Not Yet Recruiting Phase 2

• 1 other identifier: AM2023MCV4Ⅱ
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study was to explore the safety and immunogenicity of the experimental vaccine compared with the control vaccines. It is planed to enroll a total of 1,200 subjects, including 300 subjects in each of the 3-5 months old, 6-11 months old, 12-23 months old and 2-15 years old groups, who will be randomly assigned to the trial in a 1:1 ratio to study group or control group. The 3-5 month-old group will have three doses vaccination at 0, 1 and 2 month, and a booster dose at 12 months of age; the 6-11month-old and 12-23 month-old groups will each have total two doses vaccination; the 2-15 year-old group will have one dose vaccination.

Conditions

Meningococcal Meningitis

Outcome Measures

Primary Outcomes (4)

• Immunogenicity 1

  To evaluate the positive conversion rate and geometric mean titer (GMT) of meningococcal serum bactericidal activity (rSBA) antibodies for meningococcal groups A, C, Y, and W135 at 30 days in 3\~5 months old participants after primary vaccination

  30 days after primary vaccination

• Immunogenicity 2

  To evaluate the positive conversion rate and geometric mean titer (GMT) of meningococcal serum bactericidal activity (rSBA) antibodies for meningococcal groups A, C, Y, and W135 at 30 days in 6\~23 months old participants after two doses vaccination

  30 days after two doses vaccination

• Immunogenicity 3

  To evaluate the positive conversion rate and geometric mean titer (GMT) of meningococcal serum bactericidal activity (rSBA) antibodies for meningococcal groups A, C, Y, and W135 at 30 days in 2\~15 years old participants after one dose vaccination

  30 days after one dose vaccination

• Safety 1

  The incidence of adverse events (AEs)/vaccination-related AEs on days 0 to 30 after each dose of immunization for subjects in each age group

  30 days after each dose vaccination

Secondary Outcomes (10)

• Immunogenicity 4

  30 days after booster vaccination

• Immunogenicity 5

  Before booster vaccination

• Immunogenicity 6

  30 days after booster vaccination

• Immunogenicity 7

  30 days after booster vaccination

• Immunogenicity 8

  30 days after vaccination

Study Arms (8)

Experimental Group 2~15 years

EXPERIMENTAL

2\~15 years old participants who vaccinated by experimental vaccine

Biological: ACYW135 Meningococcal Polysaccharide Conjugate Vaccine

Control Group 2~15 years

ACTIVE COMPARATOR

2\~15 years old participants who vaccinated by control vaccine 2

Biological: ACYW135 Meningococcal Polysaccharide Vaccine

Experimental Group 6~23 months(0,1)

EXPERIMENTAL

6\~23 months old participants who vaccinated by experimental vaccine at month 0 and 1

Biological: ACYW135 Meningococcal Polysaccharide Conjugate Vaccine

Control Group 6~23 months(0,1)

ACTIVE COMPARATOR

6\~23 months old participants who vaccinated by control vaccine 1 at month 0 and 1

Biological: ACYW135 Meningococcal Polysaccharide Conjugate Vaccine

Experimental Group 6~23 months(0,3)

EXPERIMENTAL

6\~23 months old participants who vaccinated by experimental vaccine at month 0 and 3

Biological: ACYW135 Meningococcal Polysaccharide Conjugate Vaccine

Control Group 6~23 months(0,3)

ACTIVE COMPARATOR

6\~23 months old participants who vaccinated by control vaccine 1 at month 0 and 3

Biological: ACYW135 Meningococcal Polysaccharide Conjugate Vaccine

Experimental Group 3~5 months

EXPERIMENTAL

3\~5 months old participants who vaccinated by experimental vaccine at month 0, 1, 2 for primary vaccination, and vaccinated by experimental vaccine at 12-month old for booster vaccination

Biological: ACYW135 Meningococcal Polysaccharide Conjugate Vaccine

Control Group 3~5 months

ACTIVE COMPARATOR

3\~5 months old participants who vaccinated by control vaccine 1 at month 0, 1, 2 for primary vaccination, and vaccinated by control vaccine at 12-month old for booster vaccination

Biological: ACYW135 Meningococcal Polysaccharide Conjugate Vaccine

Interventions

ACYW135 Meningococcal Polysaccharide Conjugate Vaccine BIOLOGICAL

ACYW135 Meningococcal Polysaccharide Conjugate Vaccine was produced by meningococcal polysaccharide from group A, C, Y, W135 and conjugated protein CRM197.

Control Group 3~5 months; Control Group 6~23 months(0,1); Control Group 6~23 months(0,3); Experimental Group 2~15 years; Experimental Group 3~5 months; Experimental Group 6~23 months(0,1); Experimental Group 6~23 months(0,3)

ACYW135 Meningococcal Polysaccharide Vaccine BIOLOGICAL

ACYW135 Meningococcal Polysaccharide Vaccine was produced by meningococcal polysaccharide from group A, C, Y, W135.

Control Group 2~15 years

Eligibility Criteria

• Age: 3 Months - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• \~5 months old:
• \~5 months old;
• The subject's legal guardian voluntarily agrees to his or her child's participation in this trial and signs an informed consent form;
• The subject and/or the subject's legal guardian can comply with the relevant requirements of the clinical trial protocol;
• Have not vaccinated by any meningococcal vaccine in the past.
• \~23 months old:
• \~23 months old;
• The subject's legal guardian voluntarily agrees to his or her child's participation in this trial and signs an informed consent form;
• The subject and/or the subject's legal guardian can comply with the relevant requirements of the clinical trial protocol;
• Have not vaccinated by any other meningococcal vaccines except meningococcal group A polysaccharide vaccine in the past. If have 1 dose vaccinated of meningococcal group A polysaccharide vaccine, it will be 3 months or more separated from the previous dose of meningococcal group A polysaccharide vaccine. If two doses of meningococcal group A polysaccharide vaccine have been vaccinated, the interval between the last dose of meningococcal group A polysaccharide vaccine should be more than 6 months or more.
• \~15 years old:
• \~15 years old;
• The subject's legal guardian voluntarily agrees to his or her child's participation in this trial and signs an informed consent form (subjects aged 8-15 years old are also required to sign an informed consent form);
• The subject and/or the subject's legal guardian can comply with the relevant requirements of the clinical trial protocol; Subjects aged 2 to 6 years old have not previously been vaccinated with any meningococcal vaccine other than meningococcal polysaccharide vaccine, and the interval between the previous dose of meningococcal polysaccharide vaccine and vaccination should be more than 12 months or more; 7\~15 years old participants have not received any meningococcal vaccine in the past 3 years.

You may not qualify if:

• The temperature before vaccination on the day of vaccination is \>37.0℃;
• Have a history of invasive disease caused by meningococci confirmed by culture;
• Have a history of severe allergic reactions that require medical intervention (such as oral and throat swelling, dyspnea, hypotension or shock caused by allergies); have a history of allergies to vaccines or vaccine components (especially those allergic to diphtheria toxoid), and have concerns about vaccination History of other serious adverse reactions;
• Those with a clearly diagnosed history of thrombocytopenia or other coagulation disorders, which may cause contraindications for intramuscular injection;
• Suffer from acute disease or acute attack of chronic disease within 3 days before vaccination;
• Have a history of epilepsy, progressive neurological disease, Guillain-Barré syndrome, convulsions (except simple febrile convulsions) and mental illness;
• Known or suspected immunological dysfunction, including immunosuppressant treatment (radiation therapy, chemotherapy, corticosteroids, antimetabolites, cytotoxic drugs), human immunodeficiency virus (HIV) infection, etc.;
• Known severe congenital malformations; suffering from developmental disabilities or clinically diagnosed serious chronic diseases (such as Down syndrome, diabetes, sickle cell anemia or neurological diseases);
• Known or suspected to have serious diseases that are judged by the researcher to affect vaccination, including respiratory diseases, digestive system diseases, endocrine system diseases, immune system diseases, cardiovascular diseases, liver and kidney diseases, malignant tumors, skin diseases, etc. ;
• Long-term use (continuous use for ≥14 days) of immunosuppressants or other immunomodulatory drugs (such as corticosteroids: prednisone or similar drugs) within 6 months before vaccination with the experimental vaccine, but local use (such as ointments, eye drops, inhalants, or nasal sprays), topical administration should not exceed the dosage recommended in the label;
• Have received blood products including gamma globulin or immune globulin treatment within 3 months before vaccination (\<3 months);
• Asplenia or functional asplenia, asplenia or splenectomy caused by any condition;
• Have been vaccinated with live attenuated vaccines within 14 days (including 14 days) before vaccination, and have been vaccinated with other subunits, inactivated vaccines or recombinant protein vaccines other than live attenuated vaccines within 7 days (including 7 days);
• Currently participating in or planning to participate in other drug clinical trials during the entire trial period after receiving the experimental vaccine;
• Any situation that the researcher believes may affect the evaluation of the trial.

Sponsors & Collaborators

• Aimei Vacin BioPharm (Zhejiang) Co., Ltd.: lead

Study Sites (1)

Yunnan Center For Disease Control and Prevention

Kunming, Yunnan, 650022, China

Location

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

Study Officials

• ZHENG Yan

  YUNNAN CENTER FOR DISEASE CONROL AND PREVENTION

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ZHENG Yan

CONTACT

+8687163627796; yaqueer_zy@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• 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, 2024
• First Posted: March 29, 2024
• Study Start: March 20, 2024
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2025
• Last Updated: March 29, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)