Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Hebei Provincial Center for Diseases Control and Prevention | UNKNOWN |
| Laishui Center for Disease Control and Prevention | UNKNOWN |
| National Institutes for Food and Drug Control, China | OTHER |
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate safety of 15-Valent Pneumococcal Conjugate Vaccine in healthy volunteers aged above 3 Months.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| experimental group | Experimental | Received Vaccine: 15-valent pneumococcal Conjugate Vaccine, 0.5 ml/dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 15-Valent Pneumococcal Conjugate Vaccine | Biological | 3/1 dose(s) according to age of subjects. Single intramuscular dose contains 0.5ml 15-Valent Pneumococcal Conjugate Vaccine. |
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Du Lin, Master | Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laishui Center for Disease Control and Prevention | Recruiting | Laishui | Hebei | 074199 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D011018 | Pneumonia, Pneumococcal |
| ID | Term |
|---|---|
| D011008 | Pneumococcal Infections |
| D013290 | Streptococcal Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
Not provided
Not provided
| Simoon Record Pharma Information Consulting Co., Ltd. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
| 4 days after vaccination |
| 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 |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D018410 | Pneumonia, Bacterial |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |