Immunogenicity and Safety of Meningococcal ACYW135 Polysaccharide Conjugate Vaccine in Volunteers Aged From 3 to 35 Months

A Single-center, Randomized, Double-blind, Parallel Control Phase II Clinical Trial to Evaluate Immunogenicity and Safety of Meningococcal ACYW135 Polysaccharide Conjugate Vaccine in Healthy Volunteers Aged From 3 to 35 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 months to 35 years.

Study Overview

• Status: Completed
• Conditions: Meningitis, Meningococcal
• Intervention / Treatment: Biological: Meningococcal ACYW135 Polysaccharide Conjugate Vaccine; Biological: Meningococcal ACYW135 Polysaccharide Conjugate Vaccine

• Study Type: Interventional
• Enrollment (Actual): 720
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Guangxi
    • Liuzhou, Guangxi, China, 530028
      • Rongan Center for Disease Control and Prevention

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 months to 2 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• People aged 3-35 months;
• Subject who has not been vaccinated with meningococcal group A and C conjugate vaccine, meningococcal group A polysaccharide vaccine and meningococcal group A and C and haemophilus b conjugate vaccine at the aged of 3-11 months, and who have't given boost immunity above 1 year old, and they all meet the physical examination requirements of the project;
• Infants aged 3-11 months should be full-term (37-42 weeks of gestation) and their birth weight should meet the requirements (2500g ≤ body weight ≤ 4000g);
• The guardian signs the informed consent form;
• The guardian and his family agree to comply with the requirements of the clinical trial protocol;
• Subject who had no history of other live vaccines within 14 days before vaccination and no history of other inactivated vaccines within 7 days;
• Axillary body temperature ≤ 37.0 ℃.

Exclusion Criteria:

• History of severe allergic reactions requiring medical intervention (such as swelling of mouth and throat, dyspnea, hypotension or shock);
• Have a history of allergy to the vaccine or vaccine ingredients (especially those allergic to tetanus toxoid), or have a history of other serious adverse reactions to the vaccine;
• A clearly diagnosed history of thrombocytopenia or other coagulation disorders that may cause contraindications to intramuscular injection;
• Abnormal production process, asphyxia rescue history, or congenital malformation, developmental disorder or serious chronic disease;
• Has serious cardiovascular, liver and kidney diseases or congenital abnormalities and HIV infection;
• Suffer from encephalopathy, uncontrolled epilepsy, convulsion and other progressive nervous system diseases;
• Acute disease, severe chronic disease, acute attack of chronic disease and fever (axillary body temperature ≥ 38.0 ℃) in the past 3 days;
• Plan to participate or be participating in any other drug clinical research;
• The interval between the first dose of test vaccine and meningococcal group A polysaccharide vaccine is less than 28 days;
• 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: High dose Group; Meningococcal ACYW135 Polysaccharide Conjugate Vaccine, 40μg/dose	Biological: Meningococcal ACYW135 Polysaccharide Conjugate Vaccine; Group 1: 3/2/1 dose(s) according to age of subjects. Single intramuscular dose contains 10 µg each of Serogroup A, C, Y, and W135 polysaccharide conjugate.; Biological: Meningococcal ACYW135 Polysaccharide Conjugate Vaccine; Group 2: 3/2/1 dose(s) according to age of subjects. Single intramuscular dose contains 5 µg each of Serogroup A, C, Y, and W135 polysaccharide conjugate.
Experimental: Low dose Group; Received Vaccine: Meningococcal ACYW135 Polysaccharide Conjugate Vaccine, 20μg/dose	Biological: Meningococcal ACYW135 Polysaccharide Conjugate Vaccine; Group 1: 3/2/1 dose(s) according to age of subjects. Single intramuscular dose contains 10 µg each of Serogroup A, C, Y, and W135 polysaccharide conjugate.; Biological: Meningococcal ACYW135 Polysaccharide Conjugate Vaccine; Group 2: 3/2/1 dose(s) according to age of subjects. Single intramuscular dose contains 5 µg each of Serogroup A, C, Y, and W135 polysaccharide conjugate.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immunogenicity study of Meningococcal ACYW135 Polysaccharide Conjugate Vaccine as assessed by positive conversion rate		30 day after each vaccination
Safety study of Meningococcal ACYW135 Polysaccharide Conjugate Vaccine as assessed by the occurrence of adverse events	Evaluate the incidence of adverse reactions for Meningococcal ACYW135 Polysaccharide Conjugate Vaccine	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 21, 2018
• Primary Completion (Actual): November 21, 2019
• Study Completion (Actual): November 21, 2019

Study Registration Dates

• First Submitted: January 28, 2022
• First Submitted That Met QC Criteria: January 28, 2022
• First Posted (Actual): February 8, 2022

Study Record Updates

• Last Update Posted (Actual): February 25, 2022
• Last Update Submitted That Met QC Criteria: February 9, 2022
• Last Verified: February 1, 2022

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; Meningitis, Meningococcal; Meningitis; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: 201719805

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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