Epidemic Meningitis
Conditions
Keywords
Vaccine, ACYW135, CRM197, Safety, 3 months of age
Brief summary
This study is an open, multicenter Phase IV clinical study to evaluate the safety of vaccination with Menhycia®. The study plan is to enroll approximately 3,000 infants at 3 months of age who have not been vaccinated with any epidemic encephalitis vaccine, and to administer a total of 3 doses of Menhycia®, with a minimum of 1 month between doses, and a booster dose of 1 dose of immunization is allowed at 12 months of age.
Interventions
BIOLOGICALMCV4
4 doses of vaccine on Day 0, Day30, Day 60 and Month 12
Sponsors
CanSino Biologics Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Months to 3 Months
Healthy volunteers
Yes
Inclusion criteria
* Infants 3 months of age who had not received any epidemic encephalitis vaccine at the time of screening * The legal guardian or delegate has given informed consent, has voluntarily signed an informed consent form, and is able to comply with the requirements of the clinical study protocol
Exclusion criteria
First dose
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of localized adverse reactions in subjects | Within 7 days after each dose of vaccination |
| Incidence of systemic adverse reactions in subjects | Within 7 days after each dose of vaccination |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of adverse reactions in subjects | Within 30 days after each dose of vaccination |
| Incidence of adverse events in subjects | Within 30 days after each dose of vaccination |
| Incidence of severe adverse events | Through study completion, an average of 10 months |
Countries
China
Outcome results
None listed