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The purpose of this study is to evaluate Immunogenicity and safety of 15-Valent Pneumococcal Conjugate Vaccine in healthy volunteers aged 2 and 3 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| experimental group | Experimental | Received Vaccine: 15-valent pneumococcal Conjugate Vaccine(experimental vaccine), 0.5 ml/dose |
|
| Positive control group | Active Comparator | Received Vaccine: 13-valent pneumococcal Conjugate Vaccine(positive control vaccine), 0.5 ml/dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 15-Valent Pneumococcal Conjugate Vaccine | Biological | 4/1 dose(s) according to age of subjects. Single intramuscular dose contains 0.5ml 15-Valent Pneumococcal Conjugate Vaccine. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Du Lin, Master | Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Daming Center for Disease Control and Prevention | Daming | Hebei | 056900 | China |
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| 13-Valent Pneumococcal Conjugate Vaccine | Biological | 4/1 dose(s) according to age of subjects. Single intramuscular dose contains 0.5ml 15-Valent Pneumococcal Conjugate Vaccine. |
|
| Laishui Center for Disease Control and Prevention | Laishui | Hebei | 074199 | China |
|
| Zhengding Center for Disease Control and Prevention | Zhengding | Hebei | 050800 | China |
|
| ID | Term |
|---|---|
| D011018 | Pneumonia, Pneumococcal |
| ID | Term |
|---|---|
| D011008 | Pneumococcal Infections |
| D013290 | Streptococcal Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D018410 | Pneumonia, Bacterial |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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