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

NCT05229536 | Completed Phase 2

• 1 other identifier: 201719805
• Study Type: interventional
• Target: 720
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

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

  30 day after each vaccination

• Safety study of Meningococcal ACYW135 Polysaccharide Conjugate Vaccine as assessed by the occurrence of adverse events

  Evaluate the incidence of adverse reactions for Meningococcal ACYW135 Polysaccharide Conjugate Vaccine

  30 day after each vaccination

Study Arms (2)

High dose Group

EXPERIMENTAL

Meningococcal ACYW135 Polysaccharide Conjugate Vaccine, 40μg/dose

Biological: Meningococcal ACYW135 Polysaccharide Conjugate Vaccine

Low dose Group

EXPERIMENTAL

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

Biological: Meningococcal ACYW135 Polysaccharide Conjugate Vaccine

Interventions

Meningococcal ACYW135 Polysaccharide Conjugate Vaccine 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.

High dose Group

Eligibility Criteria

• Age: 3 Months - 35 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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 ℃.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd: lead

Study Sites (1)

Rongan Center for Disease Control and Prevention

Liuchow, Guangxi, 530028, 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 2
• 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: January 28, 2022
• First Posted: February 8, 2022
• Study Start: December 21, 2018
• Primary Completion: November 21, 2019
• Study Completion: November 21, 2019
• Last Updated: February 25, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)