Safety Study of 15-Valent Pneumococcal Conjugate Vaccine in Healthy Volunteers Aged Above 2 Months

Study Overview
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Brief Summary
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The purpose of this study is to evaluate safety of 15-Valent Pneumococcal Conjugate Vaccine in healthy volunteers aged above 3 Months.

Official Title
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A Single-center, Open, Phase I Clinical Trial to Evaluate Safety of 15-Valent Pneumococcal Conjugate Vaccine in Healthy Volunteers Aged Above 2 Months

Conditions
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Pneumonia, Pneumococcal

Intervention / Treatment
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* Biological: 15-Valent Pneumococcal Conjugate Vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 2 months old (at a minimum of 6 weeks old) and above healthy people. Subject or legal representative who consent and has signed written informed consent. Subject and parent/guardian who is able to comply with all study procedures and to use thermometer, scale and fill in diary card and contact card as required. Subject who didn't vaccinate 13-valent or 7-valent pneumococcal conjugate vaccine. Subject who did't immune with any live vaccine within 14 days and inactivated vaccine within 7 days before vaccination. Axillary temperature ≤37.0 ℃. Exclusion Criteria: Subject with a history of a prior bacterial culture of an aggressive disease caused by S. pneumoniae. Subject with any previous history of severe vaccination or drug allergy, occurrence of fever ≥ 39.0° related to vaccination of biological products for previous vaccination. Subject who are allergic to diphtheria toxins. Children below 1 year old with abnormal labor（dystocia, instrument midwifery), birth weight <2500g, asphyxia rescue history, nerve organ damage history, and pathological history of yellow plague determined by diagnosis. History of allergy，eclampsia, epilepsy,brain trauma,encephalopathy and mental disease or family disease. Subject who diagnosis of thrombocytopenia or other history of coagulopathy. 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: severe cardiovascular disease, liver and kidney disease, malignant tumor, skin disease, serious respiratory system disease, acute infection or chronic disease active period. Known or suspected to suffer from immunological abnormalities, including immunosuppressive therapy (radiotherapy, chemotherapy, corticosteroids, antimetabolic drugs, cytotoxicity drugs), HIV infection, etc. Received blood products or immunoglobulin within 3 months before enrolling (hepatitis B immunoglobulin was acceptable), or planned to use it during the clinical trial period (before blood samples were collected after immunization). Subject who plan to participate in or is in any other clinical trial (vaccines, drugs, medical devices, etc.). In pregnancy or lactation or pregnant women. ≥18-year-old subject with blood routine, blood chemistry or urinalysis laboratory collection abnormalities. Any condition that, in the judgment of investigator, may affect trial assessment.

Ages Eligible for Study
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Minimum Age: 6 Weeks

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experimental group<br>Received Vaccine: 15-valent pneumococcal Conjugate Vaccine, 0.5 ml/dose | Biological: 15-Valent Pneumococcal Conjugate Vaccine<br>* 3/1 dose(s) according to age of subjects. Single intramuscular dose contains 0.5ml 15-Valent Pneumococcal Conjugate Vaccine.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events in 30 minutes | Occurrence of adverse events in 30 minutes after each vaccination | 30 minutes after each vaccination | 
| Solicited adverse events during 7 days | Occurrence of solicited adverse events during a 7-day follow-up period after each vaccination | 7 days after each vaccination | 
| Unsolicited adverse events during 30 days | Occurrence of unsolicited adverse events during a 30-day follow-up period after each vaccination | 30 days after each vaccination | 
| SAE | Occurrence of serious adverse events (SAE) from enrolling to 6 months after all vaccinations | from enrolling to 6 months after all vaccinations | 
| Blood routine of subjects over 18 years old at the fourth day | Blood routine test results of subjects over 18 years old at the fourth day after vaccination | 4 days after vaccination | 
| Blood biochemistry of subjects over 18 years old at the fourth day | Blood biochemistry test results of subjects over 18 years old at the fourth day after vaccination | 4 days after vaccination | 
| Urine routine of subjects over 18 years old at the fourth day | Urine routine test results of subjects over 18 years old at the fourth day after vaccination | 4 days after vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjects ratio of vaccine serotype specific pneumococcal IgG antibody concentration ≥ 0.35 ug/ml or 1.0 ug/ml in 2-month-old and 3-month-old subjects | Subjects ratio of vaccine serotype specific pneumococcal IgG antibody concentration ≥ 0.35 ug/ml or 1.0 ug/ml in 2-month-old and 3-month-old subjects on 30 days after immunization with 15-valent pneumococcal polysaccharide conjugate vaccine | 30 days after immunization | 
| GMC of vaccine serotype specific pneumococcal IgG antibody in 2-month-old and 3-month-old subjects | Geometric mean concentration (GMC) of vaccine serotype specific pneumococcal IgG antibody in 2-month-old and 3-month-old subjects on 30 days after immunization with 15-valent pneumococcal polysaccharide conjugate vaccine | 30 days after immunization |