PCV13 Impact on Pneumococcal Nasopharyngeal Carriage Study (IMPACT)

Asian Foundation for Tropical Medicine Inc.

Status: Active, not recruiting

Conditions: Community-acquired Pneumonia

Treatments: Diagnostic Test: Nasopharyngeal swab

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05114902

CT-44 Study Protocol AFTM-01

Details and patient eligibility

About

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).

Full 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)

Enrollment: 451 patients

Sex: All

Ages: 8 weeks to 60 months old

Volunteers: No 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

Trial design

451 participants in 2 patient groups

PCV13 Non-vaccinated Settting

Description:

Pneumococcal vaccine-naïve children at the PCMC

Treatment:

Diagnostic Test: Nasopharyngeal swab

PCV13 Vaccinated Setting

Description:

Pneumococcal vaccine-exposed children at the SPMC

Treatment:

Diagnostic Test: Nasopharyngeal swab