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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06226714
Other study ID # CTP-MCVF-003
Secondary ID
Status Not yet recruiting
Phase Phase 3
First received
Last updated
Start date March 2024
Est. completion date October 2024

Study information

Verified date January 2024
Source CanSino Biologics Inc.
Contact Haojie Liu
Phone 022-58213600-6051
Email haojie.liu@cansinotech.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 840
Est. completion date October 2024
Est. primary completion date October 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 59 Years
Eligibility 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.

Study Design


Intervention

Biological:
MCV4
1 dose of MCV4 on Day 0
MPSV4
1 dose of MSPV4 on Day 0

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
CanSino Biologics Inc.

Outcome

Type Measure Description Time frame Safety issue
Primary Meningococcal antibody positive conversion rates for groups A, C, Y, and W135 in all subjects 30 days post immunization
Primary Geometric mean titer (GMT) of antibodies to groups A, C, Y, and W135 in all subjects 30 days post immunization
Primary Incidence of adverse reactions in all subjects Within 30 mins after immunization
Primary Incidence of adverse reactions/events in all subjects 7 days post immunization
Primary Incidence of adverse reactions/events in all subjects Within 30 days after immunization
Secondary Meningococcal antibody positivity for groups A, C, Y, and W135 30 days post immunization
Secondary Geometric mean multiplicity (GMI) of increase for groups A, C, Y, and W135 30 days post immunization
Secondary Antibody titer =1:128 ratio for groups A, C, Y, and W135 30 days post immunization
Secondary Meningococcal antibody positivity for groups A, C, Y, and W135 in selected subjects 180 days after immunization
Secondary GMT for groups A, C, Y, and W135 in selected subjects 180 days after immunization
Secondary GMI for groups A, C, Y, and W135 in selected subjects 180 days after immunization
Secondary Antibody titer =1:128 ratio for groups A, C, Y, and W135 in selected subjects 180 days after immunization
Secondary Incidence of serious adverse events (SAEs) in all subjects Within 180 days after immunization
Secondary Incidence of pregnancy events in all subjects Within 180 days after immunization
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