A Clinical Trial of ACYW135 Group Meningococcal Polysaccharide Conjugate Vaccine (CRM197 Vector) in a 4 to 6 Year-old Population

Launched by CANSINO BIOLOGICS INC. · Aug 21, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new vaccine designed to help protect children aged 4 to 6 years old from a serious infection called meningitis, which can be caused by a bacteria known as Neisseria meningitidis. Meningitis can lead to severe health issues, including fever, rash, and inflammation of the brain. The researchers want to see how well this vaccine works in preventing these dangerous infections in young children.

To participate in the trial, children must be between 4 and 6 years old and have already received at least two doses of a standard flu vaccine. However, children cannot participate if they have had a fever before the vaccine, any serious health problems, or a history of severe allergic reactions. If eligible, participants will receive the vaccine and be monitored for their health and any possible side effects. It’s important for families to know that the trial is currently active but not recruiting new participants at this time.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Children aged 4\~6 years old
• • Complete at least two doses of basic immunization with polysaccharide influenza vaccine according to the immunization program
• • 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℃
• • Previous history of immunization with meningococcal polysaccharide conjugate vaccine
• • Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.
• • History of epilepsy, convulsions or seizures or a history of psychiatric illness or family history
• • Volunteers with current meningitis or a history of meningitis
• • Volunteers treated with immunosuppressive therapy, cytotoxic therapy, glucocorticoids (excluding topical treatment, surface treatment for acute uncomplicated dermatitis, spray treatment for allergic rhinitis) within the past 6 months (\<6 months)
• • Received blood/plasma products or immunoglobulins within 60 days (\<60 days) prior to study vaccination or planned to receive blood/plasma products or immunoglobulins throughout the study period
• • Suffering from serious chronic diseases or conditions that are in a progressive stage and cannot be controlled smoothly, such as thyroid disease
• • Volunteers with known or suspected diseases that are judged by the investigator to affect vaccination such as severe respiratory disease, acute infection or active chronic disease, severe cardiovascular disease, severe liver or kidney disease, malignancy, severe infectious or allergic skin disease
• • History of serious adverse reactions associated with the vaccine and/or history of severe allergic reactions (e.g., systemic allergic reactions) to any component of the investigational vaccine
• • Immunocompromised individuals with known or suspected immunodeficiency as determined by medical history and/or physical examination (e.g., malignancy, HIV, etc.)
• • Bleeding constitution or condition associated with prolonged bleeding, investigators consider intramuscular injection to be contraindicated
• • Live attenuated vaccine given within 14 days, other vaccines given within 7 days
• • Participation in other studies involving interventions within 28 days (\<28 days) prior to study entry and/or during study participation
• • Other conditions judged by the investigator to be inappropriate for participation in this clinical trial