Immunogenicity and Safety of MCV4 in Volunteers Aged 6 Months-5 Years

April 2, 2024 updated by: Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd

A Single-center, Randomized, Blind, Positive Control Phase III Clinical Trial to Evaluate Immunogenicity and Safety of Group ACYW135 Meningococcal Polysaccharide Conjugate Vaccine in Healthy Volunteers Aged From 6 Months to 5 Years

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a Phase III, single center, randomized, blind, positive control clinical trial conducted in Hunan Province, China. The purpose of this study is to evaluate the immunogenicity and safety of Group ACYW135 Meningococcal Polysaccharide Conjugate Vaccine in healthy volunteers aged from 3 months to 5 years old. A total of 2450 subjects were included, divided into three age groups: 6-11 months old (700 subjects), 12-23 months old (1050 subjects), and 2-5 years old (700 subjects).

Study Type

Interventional

Enrollment (Actual)

2450

Phase

  • Phase 3

Contacts and Locations

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

Study Locations

  • China
    • Hunan
      • Changsha, Hunan, China, 410005
        • Hunan Center for Disease Control and Prevention

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:

For primary immunization stage:

  • Subjects aged 6 months-5 years;
  • 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 of the subject voluntarily agrees to the child's participation in the study and signs an informed consent form;
  • The guardians of the subjects have the ability to understand the research procedures and participate in all planned follow-up visits;
  • Infants and young children aged 6 to 23 months have not received the meningococcal conjugate vaccine. If they have been vaccinated with group A meningococcal polysaccharide vaccine, the interval between vaccination and the previous dose should exceed 3 months;
  • Children aged 2-5 who have not been vaccinated with meningococcal conjugate vaccine, if they have been vaccinated with meningococcal polysaccharide vaccine (including group A meningococcal polysaccharide vaccine, group A and C meningococcal polysaccharide vaccine, and group ACYW135 meningococcal polysaccharide vaccine), the interval between the last dose should exceed 12 months;
  • Subjects had no vaccination history of other live attenuated vaccines (such as BCG vaccine, live attenuated polio vaccine, rotavirus vaccine, etc.) within 14 days before vaccination, and no vaccination history of other non live vaccines (such as hepatitis B vaccine, inactivated polio vaccine, DPT vaccine, etc.) within 7 days.
  • 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 immunization stage (applicable to the 6-11 month age group):

  • Infants and young children who have been enrolled in this clinical trial between 6 and 11 months of age and have reached the age of 18 months;
  • Infants and young children who have completed basic immunization in this clinical trial;
  • According to the opinions of the researchers, the subjects and their guardians are able to comply with the requirements of the clinical trial protocol.

For immune persistence stage (applicable to the 12-23 month age group):

  • Children who have been enrolled in this clinical trial at 12-23 months of age and have completed basic immunization for 12 months; According to the researcher's opinion, the subjects and their guardians are able to comply with the requirements of the clinical trial protocol.

Exclusion Criteria:

For primary immunization stage:

  • Have a history of severe allergic reactions that require medical intervention; Have a history of allergies to vaccines or vaccine ingredients (such as lactose, sodium chloride, tetanus toxoids, etc.), and other serious adverse reactions to vaccines;
  • Has contraindications for intramuscular injection such as thrombocytopenia, any coagulation dysfunction, or undergoing anticoagulant therapy;
  • Has severely abnormal labor (dystocia, instrumental delivery, excluding cesarean section), or history of asphyxia, neurological damage, in vitro fertilization or multiple pregnancy, pathological jaundice (only applicable to infants and young children aged 6-11 months);
  • Suffering from serious congenital malformations or chronic diseases that may interfere with the progress or completion of the study (including but not limited to Down's syndrome, thalassemia (the first degree relatives in the family are thalassemia or gene carriers of thalassemia), heart disease, kidney disease, diabetes, autoimmune diseases (repeated perianal abscesses), hereditary allergies, Guillain Barre syndrome, etc.);
  • Infectious diseases with clinical or serological evidence, such as tuberculosis, hepatitis B, hepatitis C, human immunodeficiency virus (HIV) infection or HIV infected parents;
  • Any situation resulting in splenomegaly, splenectomy, or functional splenomegaly;
  • Has a history of convulsions, epilepsy, encephalopathy, and mental illness (including family history);
  • Within 3 days prior to the first dose of the vaccine, there was an acute illness or acute exacerbation of a chronic disease, or the use of antipyretic, analgesic, and anti allergic drugs (such as acetaminophen, ibuprofen, aspirin, etc.);
  • Congenital or acquired immunodeficiency; Or receive systemic corticosteroid treatment (any medication route, ≥ 2mg/kg/day) for ≥ 14 days within 3 months prior to enrollment, such as prednisone, inhaled steroids budesonide, fluticasone, etc; Or being using other immunosuppressants such as cyclosporine, tacrolimus, etc. before enrollment;
  • Has given immunoglobulin and/or any blood products (except hepatitis B immunoglobulin) within 3 months before enrollment;
  • Plan to move before the end of the study visit or leave the local area for a long time during the scheduled study visit;
  • Plan to participate or be participating in any other drug clinical research;
  • According to the researcher's judgment, there are any other factors that are not suitable for the subjects to participate in the clinical trial.

For booster immunization stage (applicable to the 6-11 month age group) and immune persistence stage (applicable to the 12-23 month age group):

  • Subjects in the experimental group aged 6-11 months received any meningococcal vaccine before blood serum collection at 18 months old after completing basic immunization;
  • Subjects in the 12-23 month age group were vaccinated with any meningococcal vaccine before completing blood collection at 12 month post-completion of primary immunization schedule;
  • After participating in this clinical trial, the subjects are known or suspected to have immunological deficiencies, including being treated with immunosuppressants (such as radiation therapy, chemotherapy, corticosteroids, anti metabolic drugs, cytotoxic drugs, etc.) and HIV infection;
  • Subjects in the experimental group aged 6-11 month old were given immunoglobulin and/or any blood products (except hepatitis B immunoglobulin) within 3 months before the booster immunization.
  • According to the researcher's judgment, there are any other factors that are not suitable for the subjects to participate in the clinical trial

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 6~11 months old
For children aged 6-11 months, they was randomly assigned in a 1:1 ratio to the experimental group and control group, and basic immunization was performed following a 0,1-month schedule. And the experimental group received one dose of booster immunization at 18 months old;
Biological: Group ACYW135 Meningococcal Polysaccharide Conjugate Vaccine
As a experimental vaccine for 6 months to 5 years old.
Biological: Group A and C Meningococcal Polysaccharide Vaccine
As a control vaccine for ages 6-11 months and 12-23 months.
Experimental: 12~23 months old
For infants aged 12-23 months, they was randomly assigned in a 1:1:1 ratio to the two-dose experimental group, one-dose experimental group, and two-dose control group. For the 12-23 month-olds in the two-dose group, they received two doses of immunization according to a 0, 1-month schedule; while those in the one-dose group receive a single dose of immunization.
Biological: Group ACYW135 Meningococcal Polysaccharide Conjugate Vaccine
As a experimental vaccine for 6 months to 5 years old.
Biological: Group A and C Meningococcal Polysaccharide Vaccine
As a control vaccine for ages 6-11 months and 12-23 months.
Experimental: 2~5 years old
For children aged 2-5 years, they were randomly assigned in a 1:1 ratio to the experimental group and control group and received a single dose of immunization.
Biological: Group ACYW135 Meningococcal Polysaccharide Conjugate Vaccine
As a experimental vaccine for 6 months to 5 years old.
Biological: Group ACYW135 Meningococcal Polysaccharide Vaccine
As a control vaccine for ages 2-5 years.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Antibody positive conversion rate
Time Frame: 30 day after primary immunization
Immunogenicity study of Meningococcal ACYW135 Polysaccharide Conjugate Vaccine as assessed by positive conversion rate (4-fold increase)
30 day after primary immunization

Collaborators and Investigators

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

Sponsor

Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd

Investigators

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

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 (Actual)

December 10, 2021

Primary Completion (Estimated)

August 30, 2024

Study Completion (Estimated)

August 30, 2024

Study Registration Dates

First Submitted

March 11, 2024

First Submitted That Met QC Criteria

March 11, 2024

First Posted (Actual)

March 18, 2024

Study Record Updates

Last Update Posted (Actual)

April 3, 2024

Last Update Submitted That Met QC Criteria

April 2, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020040C-2

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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