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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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The specific aim is to evaluate the impact of PCV13 as administered in the pediatric primary care clinic at Boston medical center on the serotype specific carriage of Streptococcus pneumoniae in children < 5.
Specifically the investigators will measure the decline in vaccine serotypes, the proportion of children receiving vaccine required to achieve 50% reduction in serotype specific carriage and the correlation between immunogenicity of the specific serotypes and decline in carriage. The study has been extended to complete 5 years of surveillance to determine the new SP serotype distribution at the time presumably a new equilibrium has been achieved.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Children <2 years of age | Children <2 years of age with and without respiratory tract infection | ||
| Children 2<5 years of age | Children 2<5 years of age with and without respiratory tract infection |
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| Measure | Description | Time Frame |
|---|---|---|
| Nasopharngeal Colonization With PCV13 S. Pneumoniae | Proportion of PCV13 serotypes among n=1851 children colonized with any S. pneumoniae | Study years 1-5 |
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Inclusion Criteria:
Exclusion Criteria:
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children < 5 years of age receiving care at Primary Care center at BMC and as many parent(s) as willing to particpate
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pediatric Primary Care, Boston Medical Center | Boston | Massachusetts | 02118 | United States |
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Children aged 0<60 months with non-toxic appearance presenting for well child or urgent care visit at urban hospital recruited from July 1, 2010 - March 27, 2015; each child could be enrolled only once per 60 day period.
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| ID | Title | Description |
|---|---|---|
| FG000 | Children 0<2 Years of Age | Children 0<2 years of age with and without respiratory tract infection |
| FG001 | Children 2<5 Years of Age | Children 2<5 years of age with and without respiratory tract infection |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Children 0<2 Years of Age | Children 0<2 years of age with and without concurrent respiratory tract infection |
| BG001 | Children 2<5 Years of Age | Children 2<5 years of age with and without concurrent respiratory tract infection |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Nasopharngeal Colonization With PCV13 S. Pneumoniae | Proportion of PCV13 serotypes among n=1851 children colonized with any S. pneumoniae | Children colonized with any S. pneumoniae (PCV and non-PCV serotypes) | Posted | Count of Participants | Participants | Study years 1-5 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Children <2 Years of Age | Children <2 years of age with and without respiratory tract infection |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stephen I Pelton | Boston Medical Center | 617-414-5591 | spelton@bu.edu |
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NP specimens and bacterial isolates of S. pneuomoniae and nontypable Haemophilus
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | months |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Pneumococcal risk factors | Count of Participants | Participants |
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| Units | Counts |
|---|---|
| Participants |
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| 0 |
| 4,035 |
| 0 |
| 4,035 |
| 0 |
| 4,035 |
| EG001 | Children 2<5 Years of Age | Children 2<5 years of age with and without respiratory tract infection | 0 | 4,755 | 0 | 4,755 | 0 | 4,755 |
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| Non-PCV13 serotype |
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| Non-PCV13 serotype |
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| Non-PCV13 serotype |
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| Non-PCV13 serotype |
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