Whole Genome-Based Surveillance of Nasopharyngeal Pneumococcal Carriage in Vietnamese Children

April 25, 2026 updated by: Phuc Huu Phan

Whole Genome-Based Surveillance of Nasopharyngeal Pneumococcal Carriage and Serotype Distribution Among Vietnamese Children Hospitalized With Acute Respiratory Symptoms

This hospital-based cross-sectional study aims to determine the prevalence and serotype distribution of nasopharyngeal Streptococcus pneumoniae carriage among children aged 2-59 months hospitalized with acute respiratory symptoms at Vietnam National Children's Hospital (VNCH). Whole genome sequencing (WGS) will be used for serotype identification, antimicrobial resistance gene detection, and characterization of co-colonization patterns. The study will compare carriage prevalence and serotype distribution between previously healthy children and children with underlying comorbidities. Findings will inform pneumococcal vaccine policy and antimicrobial resistance surveillance in Vietnam.

Study Overview

Status

Enrolling by invitation

Conditions

Detailed Description

Nasopharyngeal colonization with Streptococcus pneumoniae is a prerequisite for invasive pneumococcal disease. In Vietnam, PCV10 and PCV13 have been introduced in the private sector; however, updated surveillance data reflecting post-vaccine serotype dynamics are limited.

This study will enroll 530 children aged 2 months to 59 months hospitalized with acute respiratory symptoms. Participants will be categorized into:

  • Group 1: Previously healthy children
  • Group 2: Children with chronic underlying conditions Nasopharyngeal swabs will be collected at enrollment. Streptococcus pneumoniae isolates will undergo culture, identification using MALDI-TOF MS, and whole genome sequencing using the Illumina NextSeq platform. Bioinformatic analysis will include in silico serotyping, MLST typing, resistance gene detection, and co-colonization assessment.

The study will evaluate associations between pneumococcal carriage and demographic, clinical, vaccination, and environmental factors.

Study Type

Observational

Enrollment (Estimated)

530

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Vietnam
      • Hanoi, Vietnam, 00000
        • Vietnam National Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Children aged 2 months to 59 months hospitalized at Vietnam National Children's Hospital with acute respiratory symptoms

Description

Inclusion Criteria:

  • Age 2 months to 59 months
  • Hospitalized with acute respiratory symptoms (≤14 days duration)
  • Parent or legal guardian provides written informed consent

Acute respiratory symptoms defined as one or more of:

  • Cough
  • Rhinorrhea
  • Nasal obstruction
  • Sore throat
  • Tachypnea
  • Wheeze
  • Retraction

Exclusion Criteria:

  • Confirmed pneumococcal infection within the past 30 days

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of Pneumococcal Carriage
Time Frame: At enrollment
Proportion of participants with S. pneumoniae detected from nasopharyngeal swab Analysis: Prevalence with 95% confidence intervals
At enrollment
Pneumococcal Serotype Distribution
Time Frame: At enrollment
Frequency distribution of pneumococcal serotypes identified via Whole Genome Sequencing
At enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Antimicrobial Resistance Genes
Time Frame: at enrollment
Presence of resistance genes (e.g., ermB, mefA, pbp variants)
at enrollment
Vaccine Serotype Coverage
Time Frame: At enrollment
Proportion of identified serotypes covered by PCV10, PCV13, PCV15, PCV20
At enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Phuc Huu Phan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

September 30, 2027

Study Registration Dates

First Submitted

April 25, 2026

First Submitted That Met QC Criteria

April 25, 2026

First Posted (Actual)

May 1, 2026

Study Record Updates

Last Update Posted (Actual)

May 1, 2026

Last Update Submitted That Met QC Criteria

April 25, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • VNCH-TRICH-2026-50

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

IPD might be shared with relevant request and upon approval by local regulatory body

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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