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| ID | Type | Description | Link |
|---|---|---|---|
| 6096A1-1000 |
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This study will assess the safety and tolerability of a single dose of 13-valent Pneumococcal Conjugate Vaccine for approximately 1 month after vaccination sequentially in healthy Chinese adults aged 18 through 55 years, followed by children aged 3 through 5 years, and then infants aged approximately 2 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Adults aged 18 through 55 years (before the fifty sixth birthday) |
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| Group 2 | Experimental | Children aged 3 through 5 years (before the sixth birthday) |
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| Group 3 | Experimental | Infants aged approximately 2 months (42 to 98 days) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 13-valent Pneumococcal Conjugate Vaccine | Biological | suspension in prefilled syringe for intramuscular injection, 0.5 mL, only one dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants reporting Adverse Events | Baseline to Month 1 |
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Inclusion Criteria:
Age at the time of enrollment is:
Healthy subject as determined by medical history, physical examination, and judgment of the investigator.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Huaian | Jiangsu | 223300 | China | ||
| Pfizer Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26668712 | Derived | Zhu F, Hu Y, Liang Q, Young M Jr, Zhou X, Chen Z, Liang JZ, Gruber WC, Scott DA. Safety and tolerability of 13-valent pneumococcal conjugate vaccine in healthy Chinese adults, children and infants. Ther Adv Drug Saf. 2015 Dec;6(6):206-11. doi: 10.1177/2042098615613985. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Term |
|---|---|
| D011008 | Pneumococcal Infections |
| ID | Term |
|---|---|
| D013290 | Streptococcal Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| 13-valent Pneumococcal Conjugate Vaccine | Biological | suspension in prefilled syringe for intramuscular injection, 0.5 mL, only one dose |
|
| 13-valent Pneumococcal Conjugate Vaccine | Biological | suspension in prefilled syringe for intramuscular injection, 0.5 mL, only one dose |
|
| Nanjing |
| Jiangsu |
| 210009 |
| China |
| D007239 | Infections |