PCV13 Impact on Pneumococcal Nasopharyngeal Carriage Study

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05114902

Acronym

IMPACT

Enrollment

451

Registered

2021-11-10

Start date

2021-11-24

Completion date

2024-11-30

Last updated

2023-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Community-acquired Pneumonia

Keywords

Clinical CAP

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)

Interventions

DIAGNOSTIC_TESTNasopharyngeal swab

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

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

8 Weeks to 60 Months

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
S. pneumoniae serotypes	Upon Admission	S. pneumonia serotypes isolated from the nasopharynx of children admitted in PCV13-unvaccinated site (PCMC)
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- unvaccinated site (PCMC)

Countries

Philippines

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026