Immunogenicity and Safety of 23-Valent Pneumococcal Polysaccharide Vaccine in Healthy Volunteers Aged 2 Years and Above

Study Overview
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Brief Summary
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The purpose of this study is to evaluate Immunogenicity and safety of 23-Valent Pneumococcal Polysaccharide Vaccine in healthy volunteers aged 2 Years and above.

Official Title
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A Randomized, Blinded, Parallel Controlled, Phase Ⅲ Clinical Trial to Evaluate Immunogenicity and Safety of 23-Valent Pneumococcal Polysaccharide Vaccine in Healthy Volunteers Aged 2 Years and Above

Conditions
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Pneumonia, Pneumococcal

Intervention / Treatment
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* Biological: 23-Valent Pneumococcal Polysaccharide Vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 2 years old and above healthy people. Subject or legal representative who consent and has signed written informed consent. Subject or legal representative who is able to comply with all study procedures. Subject who didn't vaccinate pneumococcal vaccines and did't immune with any live vaccine within 14 days and inactivated vaccine within 7 days before vaccination. Axillary temperature ≤37.0 ℃. Exclusion Criteria: History of allergy，eclampsia, epilepsy, encephalopathy and mental disease or family disease. Allergic history after vaccination. Known allergy to any component of the test vaccine（the test vaccine mainly contains 23 types of pneumococcal polysaccharide and PBS buffer） Subjects who diagnosis of thrombocytopenia or other history of coagulopathy. Known immunological impairment or dysfunction. Subjects who have received whole blood, plasma, and immunoglobulin therapy within one month. Known severe congenital malformations, developmental disorders; clinically diagnosed serious chronic diseases: down's syndrome, diabetes, sickle cell anemia or neurological disorders, Guillain Barre syndrome. Known or suspected to suffer from: respiratory system disease，acute infection or chronic disease active period，severe cardiovascular disease, liver and kidney disease, malignant tumor, skin disease,children's mother has HIV infection and other serious and infectious diseases. In pregnancy or lactation or pregnant women. Subjects aged 18 years and above whose systolic blood pressure≥160mmHg and diastolic blood pressure≥100mmHg. Any contraindications that investigators consider related to vaccination.

Ages Eligible for Study
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Minimum Age: 2 Years

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: experimental group<br>Received Vaccine: 23-valent Pneumococcal Polysaccharide Vaccine(experimental vaccine), 0.5 ml/dose | Biological: 23-Valent Pneumococcal Polysaccharide Vaccine<br>* 1 dose according to age of subjects. Single intramuscular dose contains 0.5ml 23-Valent Pneumococcal Polysaccharide Vaccine.<br>|
| Active Comparator: Positive control group<br>Received Vaccine: 23-valent Pneumococcal Polysaccharide Vaccine (positive control vaccine), 0.5 ml/dose | Biological: 23-Valent Pneumococcal Polysaccharide Vaccine<br>* 1 dose according to age of subjects. Single intramuscular dose contains 0.5ml 23-Valent Pneumococcal Polysaccharide Vaccine.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunogenicity study endpoint | Percentage of participants with seroresponse to each vaccination | 30 day after each vaccination | 
| Safety study endpoint | Occurrence of adverse events during a 30 day follow-up period after each vaccination | 30 day after each vaccination |