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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Meningitis, Meningococcal

Intervention / Treatment
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* Biological: Meningococcal ACYW135 Polysaccharide Conjugate Vaccine
* Biological: Meningococcal ACYW135 Polysaccharide Conjugate Vaccine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 3 Months
Maximum Age: 35 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High dose Group<br>Meningococcal ACYW135 Polysaccharide Conjugate Vaccine, 40μg/dose | Biological: Meningococcal ACYW135 Polysaccharide Conjugate Vaccine<br>* 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.<br>|
| Experimental: Low dose Group<br>Received Vaccine: Meningococcal ACYW135 Polysaccharide Conjugate Vaccine, 20μg/dose | Biological: Meningococcal ACYW135 Polysaccharide Conjugate Vaccine<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |