PCV13 Impact on Pneumococcal Nasopharyngeal Carriage Study

Active, not recruiting

• Conditions: Community-acquired Pneumonia
• Interventions: Diagnostic Test: Nasopharyngeal swab

• Registration Number: NCT05114902
• Lead Sponsor: Asian Foundation for Tropical Medicine Inc.

Brief Summary

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

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)

Study Timeline

• Study First Submitted: 2021-10-29
• Study First Submitted QC: 2021-10-29
• Study First Posted: 2021-11-10
• Study Start: 2021-11-24
• Primary Completion: 2023-07-31
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-11
• Last Update Posted: 2023-09-13
• Study Completion: 2024-11

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 451

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PCV13 Non-vaccinated Settting	Nasopharyngeal swab	Pneumococcal vaccine-naïve children at the PCMC
PCV13 Vaccinated Setting	Nasopharyngeal swab	Pneumococcal vaccine-exposed children at the SPMC

Primary Outcome Measures

Name	Time	Method
S. pneumoniae serotypes Upon Admission	Upon Admission	S. pneumonia serotypes isolated from the nasopharynx of children admitted in PCV13-unvaccinated site (SPMC)
Antimicrobial resistance rate of S. pneumoniae	Upon Admission	Antimicrobial resistance rate isolated from the nasopharynx of children admitted as a case of radiologic CAP admitted in PCV13-vaccinated site (SPMC)
S. pneumoniae serotypes	Upon Admission	S. pneumonia serotypes isolated from the nasopharynx of children admitted in PCV13-unvaccinated site (PCMC)

Trial Locations

Locations (1)

Philippine Children's Medical Center; 🇵🇭 Quezon City, National Capital Region, Philippines