Meningococcal Meningitis
Conditions
Keywords
Vaccine, Peer controlled, Immunogenicity, Safety, 18-59 years
Brief 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.
Sponsors
CanSino Biologics Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 59 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Meningococcal antibody positive conversion rates for groups A, C, Y, and W135 in all subjects | 30 days post immunization |
| Geometric mean titer (GMT) of antibodies to groups A, C, Y, and W135 in all subjects | 30 days post immunization |
| Incidence of adverse reactions in all subjects | Within 30 mins after immunization |
| Incidence of adverse reactions/events in all subjects | 7 days post immunization |
Secondary
| Measure | Time frame |
|---|---|
| GMT for groups A, C, Y, and W135 in selected subjects | 180 days after immunization |
| GMI for groups A, C, Y, and W135 in selected subjects | 180 days after immunization |
| Meningococcal antibody positivity for groups A, C, Y, and W135 | 30 days post immunization |
| Incidence of serious adverse events (SAEs) in all subjects | Within 180 days after immunization |
| Incidence of pregnancy events in all subjects | Within 180 days after immunization |
| Antibody titer ≥1:128 ratio for groups A, C, Y, and W135 in selected subjects | 180 days after immunization |
| Geometric mean multiplicity (GMI) of increase for groups A, C, Y, and W135 | 30 days post immunization |
| Antibody titer ≥1:128 ratio for groups A, C, Y, and W135 | 30 days post immunization |
| Meningococcal antibody positivity for groups A, C, Y, and W135 in selected subjects | 180 days after immunization |
Countries
China
Outcome results
None listed