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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
| Philippine Children's Medical Center | OTHER_GOV |
| Southern Philippines Medical Center | OTHER |
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Prospective, observational, hospital based, nasopharyngeal carriage (NPC), vaccine effectiveness study Comparisons will be made in Filipino children, aged 8 weeks to ≤60 months of age at enrollment, who have been hospitalized with a radiologically-confirmed, community-acquired pneumonia (CAP).
This study will be the first of two phases (A and B). Phase A will compare a PCV13-vaccinated setting (SPMC) with an unvaccinated setting (PCMC)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PCV13 Non-vaccinated Settting | Pneumococcal vaccine-naïve children at the PCMC |
| |
| PCV13 Vaccinated Setting | Pneumococcal vaccine-exposed children at the SPMC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nasopharyngeal swab | Diagnostic Test | A sample obtained from the nasopharynx for detection of live pneumococci and pneumococcal respiratory carriage |
|
| Measure | Description | Time Frame |
|---|---|---|
| S. pneumoniae serotypes | S. pneumonia serotypes isolated from the nasopharynx of children admitted in PCV13-unvaccinated site (PCMC) | Upon Admission |
| S. pneumoniae serotypes Upon Admission | S. pneumonia serotypes isolated from the nasopharynx of children admitted in PCV13-unvaccinated site (SPMC) | Upon Admission |
| Antimicrobial resistance rate of S. pneumoniae | Antimicrobial resistance rate isolated from the nasopharynx of children admitted as a case of radiologic CAP admitted in PCV13- unvaccinated site (PCMC) | Upon Admission |
| Antimicrobial resistance rate of S. pneumoniae | Antimicrobial resistance rate isolated from the nasopharynx of children admitted as a case of radiologic CAP admitted in PCV13-vaccinated site (SPMC) | Upon Admission |
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Inclusion Criteria:
Exclusion Criteria:
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Children 8 weeks to ≤60 months of age from the National Capital Region (NCR) or Region X-XIII admitted with a medical diagnosis of clinical community-acquired pneumonia (CAP), confirmed by an abnormal chest x-ray. In Region X-XIII, the child must have received at least 1 dose of PCV13 given at <12 months.
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| Name | Affiliation | Role |
|---|---|---|
| Marilla G Lucero, MD | Asian Foundation for Tropical Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Philippine Children's Medical Center | Quezon City | National Capital Region | Philippines |
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| ID | Term |
|---|---|
| D000098968 | Community-Acquired Pneumonia |
| ID | Term |
|---|---|
| D017714 | Community-Acquired Infections |
| D007239 | Infections |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
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The retained specimen will consist of isolates of Streptococcus pneumoniae cultured from the nasopharyngeal swab.
| D012140 |
| Respiratory Tract Diseases |