Clinical Study of the Safety of Menhycia® in 3-Month-Old Infants

CanSino Biologics

Status and phase

Enrolling

Phase 4

Conditions

Epidemic Meningitis

Treatments

Biological: MCV4

Study type

Interventional

Funder types

Industry

Identifiers

NCT06389513

CTP-MCVF-005

Details and patient eligibility

About

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.

Enrollment

3,000 estimated patients

Sex

All

Ages

3 to 3 months old

Volunteers

Accepts Healthy Volunteers

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 exclusion criteria

Fever before vaccination, axillary temperature >37.0°C
Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.
History of epilepsy, convulsions or seizures or history or family history of psychiatric disorders
Acute infections or active chronic diseases, severe infectious or allergic skin diseases
Known allergy to a component of the vaccine, especially to diphtheria toxoid, or to previous administration of the product
Other circumstances that, in the judgment of the investigator, make participation in this clinical study inappropriate

Subsequent dose exclusion criteria

Severe allergic reactions after a previous dose of vaccine
Those with serious adverse reactions causally related to the previous dose of vaccination
Other circumstances that, in the judgment of the investigator, make participation in this clinical study inappropriate