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Active, not recruiting Phase 4

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

NCT05935176 · tracked via the Priya Life Science China tracker
Phase
Phase 4
Started
2023-09-20
Last updated
2026-03-04

Condition(s) studied

Epidemic Meningitis

Investigational drug(s) / intervention(s)

MCV4 →MCV4 →MCV4 →

MCV4: 2 dose of MCV4 on Day 0 and Month 1

MCV4: 2 dose of MCV4 on Day 0 and Month 3

MCV4: 1 booster dose of MCV4 at 3 years old

Study 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).

Eligibility

Sex
ALL
Min age
6 Months
Max age
23 Months
Healthy volunteers
Accepted
Part Ⅰ Inclusion Criteria: * 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 Exclusion Criteria: * 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 * Newly identified or newly occurred cases after the first vaccination that do not meet the inclusion criteria for the first dose or meet the exclusion criteria for the first dose will be determined by the investigator whether to continue to participate in the study Part Ⅱ Inclusion Criteria: * 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. Exclusion Criteria: * Fever prior to vaccination, with axillary temperature \>37.0°C * History of epilepsy, convulsions, or seizures; psychiatric history or family history of psychiatric disorders * During acute phase of illness; severe chronic disease or progressive condition not well controlled (or in acute phase) * Known allergy to any vaccine component, particularly diphtheria toxoid * Receipt of live attenuated vaccines within 14 days or other vaccines within 7 days prior to enrollment * Other conditions deemed ineligible for this clinical study by the investigator

Primary outcome measure(s)

  • 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

Trial sites (1)

FacilityCityRegionStatus
Wuzhi County Center for Disease Control and Prevention Jiaozuo Henan
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05935176 on ClinicalTrials.gov ↗ ← All trials in China