Epidemic Meningitis
Conditions
Keywords
ACYW135, CRM197, Immunogenicity, Persistence, 6~23 months of age, 3 years old
Brief summary
The purpose of this clinical study is to evaluate the immunogenicity and immunopersistence of the ACYW135 meningococcal polysaccharide conjugate vaccine (CRM197 vector).The protocol consists of two parts: Part 1 enrolled 660 eligible participants aged 6 to 23 months, which has now been completed. Part 2 : Open Clinical Researchplans to enroll approximately 100 eligible participants from Part 1 who have completed immunopreservance blood sampling. Participants will receive a single booster dose of the ACYW135 group meningococcal polysaccharide conjugate vaccine (CRM197 vector) at age 3 years (but not yet 4 years).
Detailed description
Meningococci are divided into 12 serogroups, and 95% of meningococcal cases are caused by serogroups A, B, C, X, W, and Y. Meningococcal epidemic flora can change, and the reasons are related to various factors such as meningococcal strain variation, human mobility transmission, and vaccination against different serogroups of meningococci, etc. The emergence of new serogroups of meningococci can cause the original vaccine to lose its immune protective efficacy and require a new vaccine immunization prevention strategy. the ACYW135 group meningococcal polysaccharide conjugate vaccine was approved in 2016 for a whole population The vaccine has been approved by the State Drug Administration for the prevention of epidemic meningoencephalitis caused by meningococci of groups A, C, W135 and Y in children from 3 months to 3 years of age (47 months of age).
Interventions
BIOLOGICALMCV4
2 dose of MCV4 on Day 0 and Month 1
Sponsors
CanSino Biologics Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to 23 Months
Healthy volunteers
Yes
Inclusion criteria
Part Ⅰ Inclusion Criteria: * Children aged 6 to 23 months at the time of screening * Volunteers who have not received any vaccine containing a epidemic encephalitis component or who have received only the group A polysaccharide flu vaccine and have been vaccinated more than 6 months since their last vaccination. 6 months or more between the last vaccination and the last vaccination * The legal guardian or delegate has given informed consent, voluntarily signed the informed consent form, and is able to comply with the requirements of the clinical study protocol
Exclusion criteria
* Fever before inoculation, axillary temperature \>37.0℃ * History of epilepsy, convulsions or seizures or history of psychiatric disorders or family history * During an acute illness episode; with a serious chronic illness or a condition that is in a progressive stage that cannot be smoothly controlled (or an acute episode) * Known allergy to a component of the vaccine, especially to diphtheria toxoid * Live attenuated vaccine received within 14 days or other vaccine received within 7 days prior to enrollment * Other circumstances that, in the judgment of the investigator, make participation in this clinical study inappropriate * Those who had a severe allergic reaction after the previous dose of vaccine * Those with serious adverse reactions causally related to the previous dose of vaccination * Newly identified or newly occurred cases after the first vaccination that do not meet the inclusion criteria for the first dose or meet the
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Antibody positivity for A, C, Y and W135 in all subjects 6 months after 2 dose exemption | 6 months after 2 dose exemption |
| Seroconversion rates for serotypes A, C, Y, and W135 | 30 days post-booster vaccination |
| Geometric mean titers (GMTs) for serotypes A, C, Y, and W135 | 30 days post-booster vaccination |
| Increased incidence of adverse reactions | Within 7 days after post-booster vaccination |
Secondary
| Measure | Time frame |
|---|---|
| Antibody positivity for A, C, Y and W135 in all subjects 9 months after 2 dose exemption | 9 months after 2 dose exemption |
| A, C, Y and W135 antibody positive conversion rate, positivity rate, GMT, GMI, ≥1:128 ratio in all subjects at 30 days after dose 2 exemption | 30 days after dose 2 exemption |
| A, C, Y and W135 antibody GMT, GMI, ≥1:128 ratio in all subjects at 6 and 9 months after 2 dose exemption | 6 and 9 months after 2 dose exemption |
| A, C, Y and W135 antibody GMT, positivity rate, GMI 30 days, 60 days after the first dose, and before the second dose in some subjects of the (0, 3) month immunization program | 30 days , 60 days after the first dose, and before the second dose |
| Increased incidence of adverse events | Within 7 days after post-booster vaccination |
| Increased Incidence of adverse reactions/events | Within 30 days after post-booster vaccination |
| A, C, Y, and W135 Antibody Positivity Rates and GMI and ≥1:128 Proportions | Within 30 days after post-booster vaccination |
Countries
China
Outcome results
None listed