Phase IV Clinical Study of Immunogenicity of ACYW135 Group Meningococcal Polysaccharide Conjugate Vaccine (CRM197 Vector)

NCT05935176 | Active Not Recruiting Phase 4

• 1 other identifier: CTP-MCVF-004
• Study Type: interventional
• Target: 660
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this clinical study is to evaluate the immunogenicity and immunopersistence of the ACYW135 meningococcal polysaccharide conjugate vaccine (CRM197 vector).The protocol consists of two parts: Part 1 enrolled 660 eligible participants aged 6 to 23 months, which has now been completed. Part 2 : Open Clinical Researchplans to enroll approximately 100 eligible participants from Part 1 who have completed immunopreservance blood sampling. Participants will receive a single booster dose of the ACYW135 group meningococcal polysaccharide conjugate vaccine (CRM197 vector) at age 3 years (but not yet 4 years).

Conditions

Epidemic Meningitis

Keywords

ACYW135; CRM197; Immunogenicity; Persistence; 6~23 months of age; 3 years old

Outcome Measures

Primary Outcomes (4)

• Antibody positivity for A, C, Y and W135 in all subjects 6 months after 2 dose exemption

  6 months after 2 dose exemption

• Seroconversion rates for serotypes A, C, Y, and W135

  30 days post-booster vaccination

• Geometric mean titers (GMTs) for serotypes A, C, Y, and W135

  30 days post-booster vaccination

• Increased incidence of adverse reactions

  Within 7 days after post-booster vaccination

Secondary Outcomes (7)

• Antibody positivity for A, C, Y and W135 in all subjects 9 months after 2 dose exemption

  9 months after 2 dose exemption

• A, C, Y and W135 antibody positive conversion rate, positivity rate, GMT, GMI, ≥1:128 ratio in all subjects at 30 days after dose 2 exemption

  30 days after dose 2 exemption

• A, C, Y and W135 antibody GMT, GMI, ≥1:128 ratio in all subjects at 6 and 9 months after 2 dose exemption

  6 and 9 months after 2 dose exemption

• A, C, Y and W135 antibody GMT, positivity rate, GMI 30 days, 60 days after the first dose, and before the second dose in some subjects of the (0, 3) month immunization program

  30 days , 60 days after the first dose, and before the second dose

• Increased incidence of adverse events

  Within 7 days after post-booster vaccination

Study Arms (3)

Part Ⅰ: Vaccine Group A

EXPERIMENTAL

2 dose of ACYW135 group meningococcal polysaccharide conjugate vaccine(MCV4) (0.5ml)

Biological: MCV4

PartⅠ: Vaccine Group B

EXPERIMENTAL

2 dose of MCV4 (0.5ml)

Biological: MCV4

Part Ⅱ: Vaccine Group C

EXPERIMENTAL

1 dose of MCV4 (0.5ml) at 3 years old from group B in Part I

Biological: MCV4

Interventions

MCV4 BIOLOGICAL

2 dose of MCV4 on Day 0 and Month 1

Part Ⅰ: Vaccine Group A

Eligibility Criteria

• Age: 6 Months - 23 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 6 to 23 months at the time of screening
• Volunteers who have not received any vaccine containing a epidemic encephalitis component or who have received only the group A polysaccharide flu vaccine and have been vaccinated more than 6 months since their last vaccination. 6 months or more between the last vaccination and the last vaccination
• The legal guardian or delegate has given informed consent, voluntarily signed the informed consent form, and is able to comply with the requirements of the clinical study protocol

You may not qualify if:

• Fever before inoculation, axillary temperature \>37.0℃
• History of epilepsy, convulsions or seizures or history of psychiatric disorders or family history
• During an acute illness episode; with a serious chronic illness or a condition that is in a progressive stage that cannot be smoothly controlled (or an acute episode)
• Known allergy to a component of the vaccine, especially to diphtheria toxoid
• Live attenuated vaccine received within 14 days or other vaccine received within 7 days prior to enrollment
• Other circumstances that, in the judgment of the investigator, make participation in this clinical study inappropriate
• Those who had a severe allergic reaction after the previous dose of vaccine
• Those with serious adverse reactions causally related to the previous dose of vaccination
• Part Ⅱ
• The first phase of the study has been completed, involving the (0, 3) month vaccination schedule group for subjects aged 6 to 11 months. All subjects received two doses as required, and blood samples were collected 30 days after the primary vaccination series.
• Children aged 3 years at the time of screening
• The trial participant is able and willing to comply with the requirements of the clinical trial protocol and can complete the 1-month study follow-up.
• The trial participants did not receive any meningococcal vaccine booster doses at age 3 years
• The legal guardian or authorized representative voluntarily signs the informed consent form with full knowledge and understanding, and is able to comply with the requirements of the clinical research protocol.
• Fever prior to vaccination, with axillary temperature \>37.0°C

Sponsors & Collaborators

• CanSino Biologics Inc.: lead

Study Sites (1)

Wuzhi County Center for Disease Control and Prevention

Jiaozuo, Henan, 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 Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2023
• First Posted: July 7, 2023
• Study Start: September 20, 2023
• Primary Completion (Estimated): May 15, 2026
• Study Completion (Estimated): July 15, 2026
• Last Updated: March 4, 2026

Record last verified: 2026-03

Locations

CN (1)