Safety and Immunogenicity Study of 23-valent Pneumococcal Polysaccharide Vaccine in Healthy Children, Adults and Elderly

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 an investigational 23-valent pneumococcal polysaccharide vaccine (PPV) in healthy children, adults and elderly. The control vaccine is a commercialized 23-valent PPV.

Detailed Description
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This study is a randomized, double-blind, single-center, controlled phase III clinical trial. The purpose of this study is to evaluate the immunogenicity and safety of an investigational 23-valent pneumococcal polysaccharide vaccine (PPV) manufactured by Sinovac Biotech Co., Ltd. The primary objective of this study is to demonstrate that the immunogenicity of the investigational vaccine is non-inferior to that of a commercialized 23-valent PPV manufactured by Chengdu Institute of Biological products Co., Ltd.; the secondary objective is to assess the safety of the investigational and control vaccines. Participants will be grouped into three cohorts by age: child cohort (2 - 17 years old), adult cohort (18 - 60 years old) and elderly cohort (≥ 61 years old). In each cohort, the participants will be randomly assigned into experimental group or control group in the ratio 1:1.

Official Title
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Phase III Safety and Immunogenicity Study of 23-valent Pneumococcal Polysaccharide Vaccine: A Double-blind, Randomized and Controlled Clinical Trial With 23-valent Pneumococcal Polysaccharide Vaccine in Healthy Children, Adults, and Elderly

Conditions
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Pneumococcal Infections

Intervention / Treatment
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* Biological: investigational 23-valent PPV
* Biological: control 23-valent PPV


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy volunteer ≥ 2 years old; Proven legal identity; Written consent of the guardian of participants < 18 years old, and written consent of the participant ≥ 12 years old; Complying with the requirement of the study protocol; Exclusion Criteria: Prior vaccination with pneumococcal vaccine; History of bacterial pneumonia within 3 years prior to this study; Pregnant, breast feeding, or women expected to conceive within 60 days after vaccination; History of allergy to any vaccine or vaccine ingredient; Receipt of any of the following products: Blood product within 3 months prior to study entry; Any live attenuated vaccine within 28 days prior to study entry; Any subunit vaccine or inactivated vaccine within 14 days prior to study entry; Any immunosuppressant within 6 month prior to study entry; Congenital malformation, developmental disorders, serious chronic diseases, autoimmune disease, immunodeficiency, serious cardiovascular disease, diabetes, hypertension that cannot be stabilized by medication, liver or kidney disease, or malignant tumor; History of asthma, thyroidectomy, angioneurotic edema, severe nervous system disease or mental illness; without spleen or splenectomy; diagnosed coagulation function abnormal (e.g., coagulation factor deficiency, coagulation disorder, or platelet abnormalities), or obvious bruising or coagulation disorders; Acute disease or acute stage of chronic disease within 7 days prior to study entry; Axillaty temperature > 37.0 °C; Any other factor that in the opinion of the investigator suggesting the volunteer is unsuitable for this study; Participants with the following conditions from day 0 - 28 would be included in the full analysis set (FAS), but would be excluded from the per protocol set (PPS): Receipt of any other investigational or unregistered product (drug or vaccine); Receipt of immunosuppressant (corticosteroid dosage that equivalent to or above 0.5 mg prednisone/kg weight/day) for > 14 days, except for inhalant or locally administrated corticosteroid; Receipt of immunoglobulin and/or blood product; Newly diagnosed autoimmune disease or immunodeficiency (e.g., HIV infection);

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group<br>Single intramuscular injection of the investigational vaccine (0.5 ml) on Day 0 Intervention: investigational 23-valent PPV | Biological: investigational 23-valent PPV<br>* The investigational vaccine was manufactured by Sinovac Biotech Co., Ltd.<br>|
| Active Comparator: Control Group<br>Single intramuscular injection of the control vaccine (0.5 ml) on Day 0 Intervention: control 23-valent PPV | Biological: control 23-valent PPV<br>* The control vaccine was manufactured by Chengdu Institute of Biological products Co., Ltd.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The seroconversion rates (SCR) of each of the 23 pneumococcal serotypes | For each serotype, the SCR is the percentage of participants with the increase of relative antibody concentration ≥ 2 folds after vaccination. The relative antibody concentrations were measured using Enzyme Linked Immunosorbent Assay (ELISA). | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidences of adverse events (AEs) | After each injection, a 30-minute safety observation was conducted immediately. The body temperature, occurrence of solicited local and general AEs on day 0 - 7 were reported. Unsolicited AEs occurred during day 0 - 28 were also reported. Each AE case was reviewed by the investigator to determine whether or not it was an adverse reaction (related to the vaccination). | 28 days | 
| The increases of relative antibody concentration against each of the 23 pneumococcal serotypes | The relative antibody concentrations in the pre- and post-immunization serum samples were measured using ELISA. | 28 days |