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

Meningitis, Meningococcal Clinical Trial

Official title:

A Single-center, Randomized, Double-blind, Parallel Control Phase II Clinical Trial to Evaluate Immunogenicity and Safety of Meningococcal ACYW135 Polysaccharide Conjugate Vaccine in Healthy Volunteers Aged From 3 to 35 Months

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05229536
• Other study ID #: 201719805
• Status: Completed
• Phase: Phase 2
• Start date: December 21, 2018
• Est. completion date: November 21, 2019

Study information

• Verified date: February 2022
• Source: Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 720
• Est. completion date: November 21, 2019
• Est. primary completion date: November 21, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Months to 35 Months

Eligibility

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.

Related Conditions & MeSH terms

• Meningitis
• Meningitis, Meningococcal

Intervention

Biological:
• 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.
• 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.

Locations

Country	Name	City	State
China	Rongan Center for Disease Control and Prevention	Liuzhou	Guangxi

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immunogenicity study of Meningococcal ACYW135 Polysaccharide Conjugate Vaccine as assessed by positive conversion rate		30 day after each vaccination
Primary	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