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

NCT05252715 | Active Not Recruiting Phase 3

• 1 other identifier: 2020040C-1
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Meningitis, Meningococcal

Outcome Measures

Primary Outcomes (1)

• Immunogenicity study of Meningococcal ACYW135 Polysaccharide Conjugate Vaccine as assessed by positive conversion rate

  30 day after each vaccination

Study Arms (2)

Meningococcal ACYW135 Polysaccharide Conjugate Vaccine

EXPERIMENTAL

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

Meningococcal A and C Polysaccharide Conjugate Vaccine

ACTIVE COMPARATOR

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

Interventions

Meningococcal ACYW135 Polysaccharide Conjugate Vaccine BIOLOGICAL

Single intramuscular dose contains 5 µg each of Serogroup A, C, Y, and W135 meningococcal polysaccharide combined with tetanus toxoid.

Meningococcal ACYW135 Polysaccharide Conjugate Vaccine

Meningococcal A and C Polysaccharide Conjugate Vaccine BIOLOGICAL

Single intramuscular dose contains 10 µg each of Serogroup A and C meningococcal polysaccharide combined with tetanus toxoid.

Meningococcal A and C Polysaccharide Conjugate Vaccine

Eligibility Criteria

• Age: 3 Months - 5 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd: lead

Study Sites (2)

Liujiang Center for Disease Control and Prevention

Liuchow, Guangxi, China

Location

Binyang Center for Disease Control and Prevention

Nanning, Guangxi, China

Location

MeSH Terms

Conditions

Meningitis, Meningococcal

Condition Hierarchy (Ancestors)

Meningitis, Bacterial; Central Nervous System Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Meningococcal Infections; Neisseriaceae Infections; Gram-Negative Bacterial Infections; Central Nervous System Infections; Central Nervous System Diseases; Nervous System Diseases; Meningitis; Neuroinflammatory Diseases

Study Officials

• Lin Du

  Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2022
• First Posted: February 23, 2022
• Study Start: December 18, 2021
• Primary Completion: August 22, 2023
• Study Completion: September 18, 2024
• Last Updated: April 4, 2024

Record last verified: 2024-03

Locations

CN (2)