Clinical trial NCT05935176: Phase IV Clinical Study of Immunogenicity of ACYW135 Group Meningococcal Polysaccharide Conjugate Vaccine (CRM197 Vector)
Official title: Phase IV Clinical Trial of Immunogenicity of ACYW135 Meningococcal Polysaccharide Conjugate Vaccine (CRM197 Vector) in a Population Aged 6 to 23 Months
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Epidemic Meningitis
Keywords: ACYW135
CRM197
Immunogenicity
Persistence
6~23 months of age
Lead sponsor: CanSino Biologics Inc.
Sponsor class: INDUSTRY
First posted: 2023-07-07
Enrollment: 660
Sex: ALL
Minimum age (years): 6
Maximum age (years): 23
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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).

Detailed 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).

Eligibility criteria: 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

Primary outcomes:
measure: Antibody positivity for A, C, Y and W135 in all subjects 6 months after 2 dose exemption
timeFrame: 6 months after 2 dose exemption
Secondary outcomes:
measure: Antibody positivity for A, C, Y and W135 in all subjects 9 months after 2 dose exemption
timeFrame: 9 months after 2 dose exemption
measure: 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
timeFrame: 30 days after dose 2 exemption
measure: A, C, Y and W135 antibody GMT, GMI, ≥1:128 ratio in all subjects at 6 and 9 months after 2 dose exemption
timeFrame: 6 and 9 months after 2 dose exemption
measure: 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
timeFrame: 30 days , 60 days after the first dose, and before the second dose
Other outcomes:
Locations:
city: Jiaozuo
country: China
facility: Wuzhi County Center for Disease Control and Prevention
state: Henan
Study officials:
References: