A Clinical Trial of ACYW135 Group Meningococcal Polysaccharide Conjugate Vaccine (CRM197 Vector) in 18-59 Year Olds

CanSino Biologics

Status and phase: Not yet enrolling; Phase 3

Conditions: Meningococcal Meningitis

Treatments: Biological: MCV4; Biological: MPSV4

Study type: Interventional

Funder types: Industry

Identifiers

NCT06226714

CTP-MCVF-003

Details and patient eligibility

About

This is a randomized, observer-blind, 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.

Enrollment: 840 estimated patients

Sex: All

Ages: 18 to 59 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 18~59 years old at the time of screening.
• Should not have received any meningococcal vaccine in the last 3 years.
• Volunteers 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 the 180-day study follow-up visit.
• Volunteers 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 the 180-day study follow-up visit.
• Willingness to discuss medical history with the investigator or physician and to allow access to all medical records relevant to this trial.

Exclusion criteria

• Fever before vaccination, axillary temperature >37.0°C.
• History of epilepsy, convulsions or seizures or history or family history of psychiatric disorders.
• Volunteers with current meningitis or a history of meningitis.
• Blood pregnancy-positive or breastfeeding women with a planned pregnancy within 180 days of the volunteer or her partner.
• Hypersensitivity to an ingredient or excipient of the medicinal product used in this clinical trial (mainly: group A meningococcal podophyllotoxin, group C meningococcal podophyllotoxin, group Y meningococcal podophyllotoxin, group W135 meningococcal podophyllotoxin, sucrose, mannitol, sodium chloride, dipotassium hydrogen phosphate trihydrate, potassium dihydrogen phosphate).
• Severe hypertension uncontrolled by medication (at on-site measurement: systolic blood pressure ≥ 160 mmHg, diastolic blood pressure ≥ 100 mmHg).
• Previous vaccination-related hospitalizations or emergencies.
• Bleeding constitution or condition associated with prolonged bleeding that investigators consider contraindicated for intramuscular injection.
• Other vaccinations within 14 days.
• Participation in other studies involving interventional studies within 28 days prior to study entry (<28 days) and/or during study participation.
• Other circumstances that, in the judgment of the investigator, make participation in this clinical trial inappropriate.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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840 participants in 2 patient groups

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

Experimental group

Description:

Intramuscular injection, 0.5ml

Treatment:

Biological: MCV4

ACYW135 Group Meningococcal Polysaccharide Vaccine (MPSV4)

Active Comparator group

Description:

Subcutaneous iniection, 0.5ml

Treatment:

Biological: MPSV4