Immunogenicity and Safety of Group A and C Meningococcal Polysaccharide Conjugate Vaccine in Volunteers Aged 3-5 Months

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 A and C Meningococcal Polysaccharide Conjugate Vaccine in Volunteers Aged 3-5 Months

The purpose of this study is to evaluate the immunogenicity and safety of Group A and C Meningococcal Polysaccharide Conjugate Vaccine in healthy volunteers aged from 3 to 5 months 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 Guangxi Province, China. The purpose of this study is to evaluate the immunogenicity and safety of Group A and C Meningococcal Polysaccharide Conjugate Vaccine in healthy volunteers aged from 3 to 5 months old. A total of 630 subjects were included and randomly assigned to the experimental group and control group in a 1:1 ratio.

Study Type

Interventional

Enrollment (Actual)

630

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
    • Guangxi
      • Nanning, Guangxi, China, 530028
        • Guangxi Zhuang Autonomous Region 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 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;
  • 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 and immune persistence stage

  • Infants in the experimental group who have completed primary immunization in this clinical trial and reach the age of 18 months;
  • Infants and young children who have completed primary or booster immunization in this clinical trial;
  • According to the judgment of the investigator, the subject has any other factors that are not suitable for participating in the clinical trial.

Exclusion Criteria:

For primary immunization stage

  • 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 severe abnormal labor and delivery, asphyxia rescue, congenital malformation, serious developmental disorder, serious genetic defect, serious malnutrition or serious chronic disease;
  • Suffering from serious cardiovascular diseases (pulmonary heart disease, pulmonary edema), serious liver and kidney diseases, and diabetes with complications;
  • Has been diagnosed as infectious diseases, such as tuberculosis, viral hepatitis or their parents infected with human immunodeficiency virus (HIV);
  • History or family history of encephalopathy, epilepsy, convulsions or seizures, and other progressive neurological diseases;
  • Suffering from acute illness or in the acute phase of chronic illness, or using antipyretic, analgesic, and antiallergic drugs (such as acetaminophen, ibuprofen, aspirin, etc.) three days before vaccination;
  • Long term treatment with immunosuppressants, such as long-term (continuous for more than 2 weeks) use of glucocorticoids (such as prednisone or inhaled steroids (budesonide, fluticasone) and similar drugs);
  • 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;
  • Plan to move out of the local area before the end of the study or leave for a long time during the scheduled study visit period;
  • 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 immunization and immune persistence stage

  • Has been vaccinated with any meningococcal vaccine after primary immunization and before blood collection of booster immunization;
  • Has been vaccinated with any meningococcal vaccine after booster immunization and before blood collection of immune persistence;
  • Has 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 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

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: Basic immunization
Perform basic immunization with a program of 0, 1, and 2 months, booster vaccination with 1 dose at 18 months of age.
Biological: Group A and C Meningococcal Polysaccharide Conjugate Vaccine (producted by Zhifei Lvzhu)
Performed primary immunization following a 0-1-2-month schedule at the aged from 3 to 5 months and booster immunization at 18 months of age.
Biological: Group A and C Meningococcal Polysaccharide Conjugate Vaccine (producted by Walvax)
Performed primary immunization following a 0-1-2-month schedule at the aged from 3 to 5 months.
Active Comparator: Booster immunization
Perform booster vaccination with 1 dose at 18 months of age.
Biological: Group A and C Meningococcal Polysaccharide Conjugate Vaccine (producted by Zhifei Lvzhu)
Performed primary immunization following a 0-1-2-month schedule at the aged from 3 to 5 months and booster immunization at 18 months of age.
Biological: Group A and C Meningococcal Polysaccharide Conjugate Vaccine (producted by Olymvax)
Performed booster immunization at 18 months of age.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analysis of antibody positivity conversion rate of serogroup A
Time Frame: 30 day after primary immunization
The proportion of people with pre-immunization antibody titer against serogroup A meningococcus <1:8 who achieve an antibody titer ≥1:8 after immunization.
30 day after primary immunization
Analysis of antibody positivity conversion rate of serogroup C
Time Frame: 30 day after primary immunization
The proportion of people with pre-immunization antibody titer against serogroup C meningococcus <1:8 who achieve an antibody titer ≥1:8 after immunization.
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)

September 17, 2021

Primary Completion (Estimated)

December 30, 2024

Study Completion (Estimated)

December 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

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020020C

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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