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

April 24, 2024 updated by: CanSino Biologics Inc.

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

3000

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ACYW135 Group Meningococcal Polysaccharide Conjugate Vaccine (CRM197) (MCV4)
Intramuscular injection, 0.5ml
Biological: MCV4
4 doses of vaccine on Day 0, Day30, Day 60 and Month 12

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of localized adverse reactions in subjects
Time Frame: Within 7 days after each dose of vaccination
Within 7 days after each dose of vaccination
Incidence of systemic adverse reactions in subjects
Time Frame: Within 7 days after each dose of vaccination
Within 7 days after each dose of vaccination

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of adverse reactions in subjects
Time Frame: Within 30 days after each dose of vaccination
Within 30 days after each dose of vaccination
Incidence of adverse events in subjects
Time Frame: Within 30 days after each dose of vaccination
Within 30 days after each dose of vaccination
Incidence of severe adverse events
Time Frame: Through study completion, an average of 10 months
Through study completion, an average of 10 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CanSino Biologics Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2024

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

April 1, 2025

Study Registration Dates

First Submitted

April 24, 2024

First Submitted That Met QC Criteria

April 24, 2024

First Posted (Actual)

April 29, 2024

Study Record Updates

Last Update Posted (Actual)

April 29, 2024

Last Update Submitted That Met QC Criteria

April 24, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTP-MCVF-005

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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