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

Last updated: December 2, 2024
Sponsor: CanSino Biologics Inc.
Overall Status: Active - Not Recruiting

Phase

4

Condition

Meningitis

Treatment

MCV4

Clinical Study ID

NCT05935176
CTP-MCVF-004
  • Ages 6-23
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

ACYW135 group meningococcal polysaccharide conjugate vaccine produced by Conchino Biologicals JSC is a covalent coupling conjugate of purified meningococcal podococcal polysaccharide of groups A, C, Y and W135 with CRM197 protein of diphtheria bacillus non-virulent mutant. The purpose of this clinical study is to evaluate the immunogenicity and immunopersistence of the ACYW135 meningococcal polysaccharide conjugate vaccine (CRM197 vector).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Children aged 6 to 23 months at the time of screening

  • Volunteers who have not received any vaccine containing a epidemic encephalitiscomponent or who have received only the group A polysaccharide flu vaccine and havebeen vaccinated more than 6 months since their last vaccination. 6 months or morebetween the last vaccination and the last vaccination

  • The legal guardian or delegate has given informed consent, voluntarily signed theinformed consent form, and is able to comply with the requirements of the clinicalstudy protocol

Exclusion

Exclusion Criteria:

  • Fever before inoculation, axillary temperature >37.0℃

  • History of epilepsy, convulsions or seizures or history of psychiatric disorders orfamily history

  • During an acute illness episode; with a serious chronic illness or a condition thatis 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 7days prior to enrollment

  • Other circumstances that, in the judgment of the investigator, make participation inthis 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 ofvaccination

  • Newly identified or newly occurred cases after the first vaccination that do notmeet the inclusion criteria for the first dose or meet the exclusion criteria forthe first dose will be determined by the investigator whether to continue toparticipate in the study

Study Design

Total Participants: 660
Treatment Group(s): 1
Primary Treatment: MCV4
Phase: 4
Study Start date:
September 20, 2023
Estimated Completion Date:
January 31, 2025

Study Description

Meningococci are divided into 12 serogroups, and 95% of meningococcal cases are caused by serogroups A, B, C, X, W, and Y. Meningococcal epidemic flora can change, and the reasons are related to various factors such as meningococcal strain variation, human mobility transmission, and vaccination against different serogroups of meningococci, etc. The emergence of new serogroups of meningococci can cause the original vaccine to lose its immune protective efficacy and require a new vaccine immunization prevention strategy. the ACYW135 group meningococcal polysaccharide conjugate vaccine was approved in 2016 for a whole population The vaccine has been approved by the State Drug Administration for the prevention of epidemic meningoencephalitis caused by meningococci of groups A, C, W135 and Y in children from 3 months to 3 years of age (47 months of age).

Connect with a study center

  • Wuzhi County Center for Disease Control and Prevention

    Jiaozuo, Henan
    China

    Site Not Available

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