Immunogenicity and Safety of Meningococcal ACYW135 Polysaccharide Conjugate Vaccine in Volunteers Aged From 3 to 5 Months

A Single-center, Randomized, Blind, Positive Control Phase III Clinical Trial to Evaluate Immunogenicity and Safety of Meningococcal ACYW135 Polysaccharide Conjugate Vaccine in Healthy Volunteers Aged From 3 to 5 Months

The purpose of this study is to evaluate the immunogenicity and safety of Meningococcal ACYW135 Polysaccharide Conjugate Vaccine in healthy volunteers aged from 3 to 5 months.

Study Overview

• Status: Active, not recruiting
• Conditions: Meningitis, Meningococcal
• Intervention / Treatment: Biological: Meningococcal ACYW135 Polysaccharide Conjugate Vaccine; Biological: Meningococcal A and C Polysaccharide Conjugate Vaccine

• Study Type: Interventional
• Enrollment (Estimated): 1200
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Guangxi
    • Liuzhou, Guangxi, China
      • Liujiang Center for Disease Control and Prevention
    • Nanning, Guangxi, China
      • Binyang Center for Disease Control and Prevention

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 months to 5 months (Child)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

For primary vaccination

• Subjects aged 3-5 months;
• Subjects should be full-term (37-42 weeks of gestation) and their birth weight should meet the requirements (2500g ≤ body weight ≤ 4000g);
• Axillary body temperature ≤ 37.0 ℃;
• The guardian signs the informed consent form;
• The guardian and his family agree to comply with the requirements of the clinical trial protocol;
• Subjects who have not been vaccinated with meningococcal group A and C conjugate vaccine at the aged of 3-5 months;
• Subjects who had no history of other live vaccines within 14 days before vaccination and no history of other inactivated vaccines within 7 days;

For booster vaccination

• Infants in the experimental group who have completed primary immunization in this clinical trial and reach the age of 18 months;
• The guardian and his family agree to comply with the requirements of the clinical trial protocol.

Exclusion Criteria:

For primary vaccination

• Test-tube baby who is suffering from perianal abscess, severe eczema or pathological jaundice;
• History of severe allergic reactions requiring medical intervention (such as swelling of mouth and throat, dyspnea, hypotension or shock);
• A clearly diagnosed history of thrombocytopenia or other coagulation disorders that may cause contraindications to intramuscular injection;
• History of Abnormal production process, asphyxia rescue, or congenital malformation, serious developmental disorder, serious genetic defect, serious malnutrition or serious chronic disease;
• Have been diagnosed as infectious diseases, such as tuberculosis, viral hepatitis or their parents infected with human immunodeficiency virus (HIV);
• Have progressive nervous system diseases such as encephalopathy, epilepsy, convulsions or related family history;
• History of acute disease, severe chronic disease, acute attack of chronic disease and fever (axillary body temperature ≥ 38.0 ℃) or take antipyretic, analgesic and antiallergic drugs (such as acetaminophen, ibuprofen, aspirin, etc.) in the past 3 days;
• History of using illegal drugs (receiving systemic corticosteroid treatment≥2mg/kg/day through any route of administration, and using ≥14 days, such as prednisone, inhaled hormone budesonide, fluticasone, etc., or receiving other immunosuppressants, such as cyclophosphamide, etc.);
• History of using immunoglobulins and / or any blood products (except hepatitis B immunoglobulin) within 3 months before enrollment;
• Plan to participate or be participating in any other drug clinical research;
• According to the judgment of the investigator, the subject has any other factors that are not suitable for participating in the clinical trial.

For booster vaccination

• The subjects were vaccinated with any meningococcal vaccine after primary immunization and before blood collection of booster immunization;
• The subjects have been known or suspected to have immunological defects since participating in this clinical trial, including being treated with immunosuppressants (such as chemotherapy, corticosteroids, antimetabolics, cytotoxic drugs, etc.) and HIV infection;
• History of using immunoglobulins and / or any blood products (except hepatitis B immunoglobulin) within 3 months before booster immunization;
• According to the judgment of the investigator, the subject has any other factors that are not suitable for participating in the clinical trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Meningococcal ACYW135 Polysaccharide Conjugate Vaccine; Meningococcal ACYW135 Polysaccharide Conjugate Vaccine, 20 µg/dose. Primary vaccination at 0, 1 and 2 months of age, respectively. Booster vaccination at 18 months of age.	Biological: Meningococcal ACYW135 Polysaccharide Conjugate Vaccine; Single intramuscular dose contains 5 µg each of Serogroup A, C, Y, and W135 meningococcal polysaccharide combined with tetanus toxoid.
Active Comparator: Meningococcal A and C Polysaccharide Conjugate Vaccine; Meningococcal A and C Polysaccharide Conjugate Vaccine, 20 µg/dose. Primary vaccination at 0, 1 and 2 months of age, respectively.	Biological: Meningococcal A and C Polysaccharide Conjugate Vaccine; Single intramuscular dose contains 10 µg each of Serogroup A and C meningococcal polysaccharide combined with tetanus toxoid.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Immunogenicity study of Meningococcal ACYW135 Polysaccharide Conjugate Vaccine as assessed by positive conversion rate	30 day after each vaccination

Collaborators and Investigators

• Sponsor: Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
• Investigators: Study Chair: Lin Du, Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2021
• Primary Completion (Actual): August 22, 2023
• Study Completion (Estimated): September 18, 2024

Study Registration Dates

• First Submitted: February 13, 2022
• First Submitted That Met QC Criteria: February 13, 2022
• First Posted (Actual): February 23, 2022

Study Record Updates

• Last Update Posted (Actual): April 4, 2024
• Last Update Submitted That Met QC Criteria: April 2, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Infections; Central Nervous System Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Meningitis, Bacterial; Central Nervous System Bacterial Infections; Meningococcal Infections; Neisseriaceae Infections; Neuroinflammatory Diseases; Meningitis, Meningococcal; Meningitis; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: 2020040C-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No