PCV13 Impact on Pneumococcal Nasopharyngeal Carriage Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

451 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-24

Study Completion Date

2024-11-30

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).

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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)

Conditions

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Community-acquired Pneumonia

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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PCV13 Non-vaccinated Settting

Pneumococcal vaccine-naïve children at the PCMC

Nasopharyngeal swab

Intervention Type DIAGNOSTIC_TEST

A sample obtained from the nasopharynx for detection of live pneumococci and pneumococcal respiratory carriage

PCV13 Vaccinated Setting

Pneumococcal vaccine-exposed children at the SPMC

Nasopharyngeal swab

Intervention Type DIAGNOSTIC_TEST

A sample obtained from the nasopharynx for detection of live pneumococci and pneumococcal respiratory carriage

Interventions

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Nasopharyngeal swab

A sample obtained from the nasopharynx for detection of live pneumococci and pneumococcal respiratory carriage

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

1. Child 8 weeks to ≤60 months of age
2. Resident of the National Capital Region (NCR) or Region X-XIII
3. Child admitted with a medical diagnosis of clinical CAP based on history and physical exam
4. Written informed consent obtained from a parent or legal guardian
5. At SPMC site, child must have received at least 1 dose of PCV13 given at \<12 months based on history-taking
6. 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

1. Children with a known primary or secondary immunodeficiency
2. 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
3. For Phase A at PCMC site, child with any PCV in the past based on history-taking

Minimum Eligible Age

8 Weeks

Maximum Eligible Age

60 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No