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

NCT06389513 | Active Not Recruiting Phase 4

• 1 other identifier: CTP-MCVF-005
• Study Type: interventional
• Target: 3,011
• Locations: 1 country
• Sites: 1

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.

Conditions

Epidemic Meningitis

Keywords

Vaccine; ACYW135; CRM197; Safety; 3 months of age

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• 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

Study Arms (1)

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

EXPERIMENTAL

Intramuscular injection, 0.5ml

Biological: MCV4

Interventions

MCV4 BIOLOGICAL

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

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

Eligibility Criteria

• Age: 3 Months - 3 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• CanSino Biologics Inc.: lead

Study Sites (1)

Nanjing Luhe District Center for Disease Control and Prevention Center for Disease Control and Prevention

Nanjing, China

Location

MeSH Terms

Conditions

Meningitis, Meningococcal

Condition Hierarchy (Ancestors)

Meningitis, Bacterial; Central Nervous System Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Meningococcal Infections; Neisseriaceae Infections; Gram-Negative Bacterial Infections; Central Nervous System Infections; Central Nervous System Diseases; Nervous System Diseases; Meningitis; Neuroinflammatory Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2024
• First Posted: April 29, 2024
• Study Start: June 12, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: August 15, 2025

Record last verified: 2025-08

Locations

CN (1)