PCV13 Impact on Pneumococcal Nasopharyngeal Carriage Study (IMPACT)

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

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Community-acquired Pneumonia
• Intervention / Treatment: Diagnostic test: Nasopharyngeal swab

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 Type: Observational
• Enrollment (Actual): 451

Contacts and Locations

Study Locations

• Philippines
  • National Capital Region
    • Quezon City, National Capital Region, Philippines
      • Philippine Children's Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 5 years (Child)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Children 8 weeks to ≤60 months of age from the National Capital Region (NCR) or Region X-XIII admitted with a medical diagnosis of clinical community-acquired pneumonia (CAP), confirmed by an abnormal chest x-ray. In Region X-XIII, the child must have received at least 1 dose of PCV13 given at <12 months.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
PCV13 Non-vaccinated Settting; Pneumococcal vaccine-naïve children at the PCMC	Diagnostic test: Nasopharyngeal swab; 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	Diagnostic test: Nasopharyngeal swab; A sample obtained from the nasopharynx for detection of live pneumococci and pneumococcal respiratory carriage

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Asian Foundation for Tropical Medicine Inc.
• Collaborators: Pfizer; Southern Philippines Medical Center; Philippine Children's Medical Center, Philippines
• Investigators: Principal Investigator: Marilla G Lucero, MD, Asian Foundation for Tropical Medicine

Study record dates

Study Major Dates

• Study Start (Actual): November 24, 2021
• Primary Completion (Actual): July 31, 2023
• Study Completion (Estimated): November 1, 2024

Study Registration Dates

• First Submitted: October 29, 2021
• First Submitted That Met QC Criteria: October 29, 2021
• First Posted (Actual): November 10, 2021

Study Record Updates

• Last Update Posted (Actual): September 13, 2023
• Last Update Submitted That Met QC Criteria: September 11, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Clinical CAP
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Pneumonia
• Other Study ID Numbers: CT-44 Study Protocol AFTM-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No