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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

3011 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-12

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Epidemic Meningitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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ACYW135 Group Meningococcal Polysaccharide Conjugate Vaccine (CRM197) (MCV4)

Intramuscular injection, 0.5ml

Group Type EXPERIMENTAL

MCV4

Intervention Type BIOLOGICAL

4 doses of vaccine on Day 0, Day30, Day 60 and Month 12

Interventions

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MCV4

4 doses of vaccine on Day 0, Day30, Day 60 and Month 12

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

* 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

* 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

Minimum Eligible Age

3 Months

Maximum Eligible Age

3 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes