Clinical trial NCT05229536: Immunogenicity and Safety of Meningococcal ACYW135 Polysaccharide Conjugate Vaccine in Volunteers Aged From 3 to 35 Months
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Meningitis, Meningococcal
Lead sponsor: Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
Sponsor class: INDUSTRY
First posted: 2022-02-08
Enrollment: 720
Sex: ALL
Minimum age (years): 3
Maximum age (years): 35
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Immunogenicity study of Meningococcal ACYW135 Polysaccharide Conjugate Vaccine as assessed by positive conversion rate
timeFrame: 30 day after each vaccination
measure: Safety study of Meningococcal ACYW135 Polysaccharide Conjugate Vaccine as assessed by the occurrence of adverse events
timeFrame: 30 day after each vaccination
Secondary outcomes:
Other outcomes:
Locations:
city: Liuzhou
country: China
facility: Rongan Center for Disease Control and Prevention
state: Guangxi
Study officials:
affiliation: Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
name: Lin Du
role: STUDY_CHAIR
References: