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

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

Status

Enrolling by invitation

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07562529

Enrollment

530

Registered

2026-05-01

Start date

2026-04-01

Completion date

2027-09-30

Last updated

2026-05-01

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

Conditions

Acute Respiratory Symptoms, Pneumococcal Colonization, Streptococcus Pneumoniae Carriage

Keywords

Pneumococcal carriage, Whole genome sequencing, Serotype distribution, PCV vaccine coverage, Vietnam, Pediatric surveillance

Brief summary

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.

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

2 Months to 5 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

Vietnam

Outcome results