PCV13 Impact on Pneumococcal Nasopharyngeal Carriage Study

Study Overview
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Brief Summary
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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).

Detailed Description
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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)

Official Title
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Assessing the Impact of PCV13 on Pneumococcal Nasopharyngeal Colonization in Children 8 Weeks to ≤60 Months of Age Hospitalized for Pneumonia in the Philippines

Conditions
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Community-acquired Pneumonia

Intervention / Treatment
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* Diagnostic Test: Nasopharyngeal swab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Child 8 weeks to ≤60 months of age Resident of the National Capital Region (NCR) or Region X-XIII Child admitted with a medical diagnosis of clinical CAP based on history and physical exam Written informed consent obtained from a parent or legal guardian At SPMC site, child must have received at least 1 dose of PCV13 given at <12 months based on history-taking For Phase B at PCMC site, child must have received at least 1 dose of PCV13 given at <12 months based on history-taking Exclusion Criteria: Children with a known primary or secondary immunodeficiency Child with a contraindication to doing a nasopharyngeal swab which may include, but is not limited to: dyscrasias, coagulation disorders, or other diseases (e.g., hemophilia, purpura), presence of craniofacial abnormalities32 For Phase A at PCMC site, child with any PCV in the past based on history-taking

Ages Eligible for Study
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Minimum Age: 8 Weeks
Maximum Age: 60 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PCV13 Non-vaccinated Settting<br>Pneumococcal vaccine-naïve children at the PCMC | Diagnostic Test: Nasopharyngeal swab<br>* A sample obtained from the nasopharynx for detection of live pneumococci and pneumococcal respiratory carriage<br>|
| PCV13 Vaccinated Setting<br>Pneumococcal vaccine-exposed children at the SPMC | Diagnostic Test: Nasopharyngeal swab<br>* A sample obtained from the nasopharynx for detection of live pneumococci and pneumococcal respiratory carriage<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Clinical CAP