Meningococcal Meningitis
Conditions
Keywords
Vaccine, Peer controlled, Immunogenicity, Safety, 7-17 years
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.
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
7 Years to 17 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Meningococcal Antibody Positive Conversion Rates and GMT for Groups A, C, Y, and W135 in All Subjects | 30 Days After Immunization |
| Geometric Mean Titer (GMT) for Groups A, C, Y, and W135 in All Subjects | 30 Days after immunization |
| Incidence of adverse reactions in all subjects | Within 30 mins after immunization |
| Incidence of adverse reactions/events in all subjects | Within 7 days after immunization |
Secondary
| Measure | Time frame |
|---|---|
| Meningococcal antibody positivity for groups A, C, Y, and W135 | 30 days after immunization |
| Geometric mean multiplicity of increase (GMI) for groups A, C, Y, and W135 | 30 days after immunization |
| Antibody titer ≥1:128 ratio for groups A, C, Y, and W135 | 30 days after immunization |
| Meningococcal Antibody Positivity for Groups A, C, Y, and W135 in Selected Subjects | 180 days after immunization |
| 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 |
| Antibody Titer ≥1:128 Ratio for Groups A, C, Y, and W135 in Selected Subjects | 180 days after immunization |
| Incidence of Serious Adverse Events (SAEs) for all subjects | Within 180 days after immunization |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORZhiqiang Xie
Henan Center for Disease Control and Prevention
Outcome results
None listed