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The goal of this clinical trial is to learn about persistence of immunity of PCV13 in healthy population aged 2 months, 7 months-5 years. The main questions it aims to answer are the percentage of subjects reached the IgG level of ≥0.35 µg/mL, GMCs level for IgG antibody, and SAEs from one month to 12 months after the last injection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2 months group | Other |
| |
| 7-11 months group | Other |
| |
| 12-23 months group | Other |
| |
| 2-5 years old group | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PCV13 | Biological | 3 doses of PCV13 intramuscularly at Months 0, 2, and 4 and a booster dose at Month 10 |
|
| Measure | Description | Time Frame |
|---|---|---|
| percentage of subjects reached the IgG level of ≥0.35 µg/mL | evaluation time: two years after the first dose for 2-5 years old group, two and three years after the first dose for 12-23 months group, two, three and four years after the first dose for 7-11 months group, two, three, four and five years after the first dose for 2 months group. | 2-5 years after the first dose |
| GMCs level for IgG antibody | evaluation time: two years after the first dose for 2-5 years old group, two and three years after the first dose for 12-23 months group, two, three and four years after the first dose for 7-11 months group, two, three, four and five years after the first dose for 2 months group. | 2-5 years after the first dose |
| Serious Adverse Events (SAE) | one months to 12 months after the last injection |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jiangsu Provincial Center for Diseases Control and Prevention | Nanjing | Jiangsu | 210000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39217777 | Derived | Li G, Ren T, Zhang H, Ti J, Chang X, Yin S, Guan Y, Liu G, Liang Q, Liu J. Persistence of immunity in children aged 2 months and 7 months - 5 years old after primary immunization with 13-valent pneumococcal conjugate vaccine. Vaccine. 2024 Oct 24;42(24):126209. doi: 10.1016/j.vaccine.2024.126209. Epub 2024 Aug 31. |
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| ID | Term |
|---|---|
| D011014 | Pneumonia |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| PCV13 | Biological | 2 doses of PCV13, and a booster dose |
|
| PCV13 | Biological | 2 doses of PCV13 |
|
| PCV13 | Biological | single dose of PCV13 |
|