Clinical trial NCT06700148: A Clinical Trial of ACYW135 Group Meningococcal Polysaccharide Conjugate Vaccine (CRM197 Vector) in 7 to 17 Year Olds
Official title: A Randomized, Blinded, Peer-controlled Clinical Trial to Evaluate the Safety and Immunogenicity of ACYW135 Group Meningococcal Polysaccharide Conjugate Vaccine (CRM197 Vector) in 7-17 Year Olds
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Meningococcal Meningitis
Keywords: Vaccine
Peer controlled
Immunogenicity
Safety
7-17 years
Lead sponsor: CanSino Biologics Inc.
Sponsor class: INDUSTRY
First posted: 2024-11-21
Enrollment: 840
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a randomized, blinded, peer-controlled study. There will be 2 treatment groups, screened subjects were given study numbers in the order of enrollment and randomly assigned to the test and control groups in a 1:1 ratio. Subjects were required to complete a 1-dose immunization program with 0.5 ml of vaccine in both the test and control groups, afterwards some subjects entered the immune persistence group.


Eligibility criteria: Inclusion Criteria:

* 7\~17 years old at the time of screening
* Volunteers and their legal guardians or delegates have given informed consent, have voluntarily signed an informed consent form, are able and willing to comply with the requirements of the clinical trial protocol, and are able to complete 180 days of study follow-up
* Willingness to discuss medical history with the investigator or physician and to allow access to all medical records related to this trial

Exclusion Criteria:

* Fever on the day of vaccination, axillary temperature \>37.0°C
* Have a moderate or severe acute illness/infection
* Positive urine pregnancy test for females of childbearing age, or plan to become pregnant within 30 days after vaccination
* Current meningitis or history of meningitis
* Allergy to certain components or excipients of the drugs used in this clinical trial (mainly including: group A meningococcal podoplanoside, group C meningococcal podoplanoside, group Y meningococcal podoplanoside, group W135 meningococcal podoplanoside, sucrose, mannitol, sodium chloride, dipotassium hydrogen phosphate trihydrate, potassium dihydrogen phosphate)
* History of epilepsy, convulsions or seizures or history or family history of psychiatric disorders
* Previous severe allergic reactions due to drugs or vaccines
* Bleeding constitution or condition associated with prolonged bleeding, which in the opinion of the investigator makes intramuscular injection contraindicated
* Any meningococcal vaccine in the last 1 year
* Any other vaccine within 14 days
* Participation in other studies involving interventional studies within 28 days (\<28 days) prior to study entry and/or during study participation
* Other conditions that, in the judgment of the investigator, make participation in this clinical trial unsuitable

Primary outcomes:
measure: Meningococcal Antibody Positive Conversion Rates and GMT for Groups A, C, Y, and W135 in All Subjects
timeFrame: 30 Days After Immunization
measure: Geometric Mean Titer (GMT) for Groups A, C, Y, and W135 in All Subjects
timeFrame: 30 Days after immunization
measure: Incidence of adverse reactions in all subjects
timeFrame: Within 30 mins after immunization
measure: Incidence of adverse reactions/events in all subjects
timeFrame: Within 7 days after immunization
measure: Incidence of adverse reactions/events in all subjects
timeFrame: Within 30 days after immunization
Secondary outcomes:
measure: Meningococcal antibody positivity for groups A, C, Y, and W135
timeFrame: 30 days after immunization
measure: Geometric mean multiplicity of increase (GMI) for groups A, C, Y, and W135
timeFrame: 30 days after immunization
measure: Antibody titer ≥1:128 ratio for groups A, C, Y, and W135
timeFrame: 30 days after immunization
measure: Meningococcal Antibody Positivity for Groups A, C, Y, and W135 in Selected Subjects
timeFrame: 180 days after immunization
measure: GMT for Groups A, C, Y, and W135 in Selected Subjects
timeFrame: 180 days after immunization
measure: GMI for Groups A, C, Y, and W135 in Selected Subjects
timeFrame: 180 days after immunization
measure: Antibody Titer ≥1:128 Ratio for Groups A, C, Y, and W135 in Selected Subjects
timeFrame: 180 days after immunization
measure: Incidence of Serious Adverse Events (SAEs) for all subjects
timeFrame: Within 180 days after immunization
Other outcomes:
Locations:
city: Dengfeng
country: China
facility: Dengfeng Center for Disease Control and Prevention
city: Kaifeng
country: China
facility: Kaifeng Center for Disease Control and Prevention
Study officials:
affiliation: Henan Center for Disease Control and Prevention
name: Zhiqiang Xie
role: PRINCIPAL_INVESTIGATOR
References: