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

NCT ID: NCT05229536

Last Updated: 2022-02-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 720 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-21
• Study Completion Date: 2019-11-21

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 months to 35 years.

Conditions

Meningitis, Meningococcal

Study Design

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

Study Groups

High dose Group

Meningococcal ACYW135 Polysaccharide Conjugate Vaccine, 40μg/dose

Group Type: EXPERIMENTAL

Meningococcal ACYW135 Polysaccharide Conjugate Vaccine

Intervention Type: BIOLOGICAL

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.

Low dose Group

Received Vaccine: Meningococcal ACYW135 Polysaccharide Conjugate Vaccine, 20μg/dose

Group Type: EXPERIMENTAL

Meningococcal ACYW135 Polysaccharide Conjugate Vaccine

Intervention Type: BIOLOGICAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 3 Months
• Maximum Eligible Age: 35 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

Rongan Center for Disease Control and Prevention

Liuzhou, Guangxi, China

Countries

China

Other Identifiers

201719805

Identifier Type: -

Identifier Source: org_study_id