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

NCT ID: NCT05252715

Last Updated: 2024-04-04

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 1200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-18
• Study Completion Date: 2024-09-18

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Meningococcal ACYW135 Polysaccharide Conjugate Vaccine

Intervention Type: BIOLOGICAL

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

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.

Group Type: ACTIVE_COMPARATOR

Meningococcal A and C Polysaccharide Conjugate Vaccine

Intervention Type: BIOLOGICAL

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

Interventions

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.

Intervention Type: 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.

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 3 Months
• Maximum Eligible Age: 5 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lin Du

Role: STUDY_CHAIR

Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd

Locations

Liujiang Center for Disease Control and Prevention

Liuzhou, Guangxi, China

Binyang Center for Disease Control and Prevention

Nanning, Guangxi, China

Countries

China

Other Identifiers

2020040C-1

Identifier Type: -

Identifier Source: org_study_id