A Clinical Trial of ACYW135 Group Meningococcal Polysaccharide Conjugate Vaccine (CRM197 Vector) in 7 to 17 Year Olds

CanSino Biologics

Status and phase: Active, not recruiting; Phase 3

Conditions: Meningococcal Meningitis

Treatments: Biological: MPSV4; Biological: MCV4

Study type: Interventional

Funder types: Industry

Identifiers

NCT06700148

CTP-MCVF-010

Details and patient eligibility

About

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.

Enrollment: 840 patients

Sex: All

Ages: 7 to 17 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

840 participants in 2 patient groups

ACYW135 Group Meningococcal Polysaccharide Conjugate Vaccine (CRM197)(MCV4)

Experimental group

Treatment:

Biological: MCV4

ACYW135 Group Meningococcal Polysaccharide Vaccine (MPSV4)

Active Comparator group

Treatment:

Biological: MPSV4