Prevalence and Serotype Distribution of Streptococcus Pneumoniae in Healthy Vietnamese Children From 6 Months to 5 Years Old

This observational study is designed as a cross-sectional survey of children from 6 months and 5 years old who visit the Vietnam Vaccination Center (VNVC) system in Hanoi, Danang and Ho Chi Minh City for vaccination services.

After getting the informed consent form from a parent/guardian for their child(s) to participate in the study, nasopharyngeal swab sample will be taken. His/her guardian will be interviewed face-to-face with information related to epidemiological characteristics, nutritional status, child's birth history, hospitalization history, vaccination history, recent antibiotic usage, breastfeeding time, and environmental and lifestyle factors.

The goal is to document the burden and risk factors of pneumococcal infections in the community of healthy Vietnamese children. The main questions it aims to answer are:

• What is the prevalence of pneumococcus in healthy children?
• What is the distribution of pneumococcus serotypes in the community of healthy Vietnamese children?
• What are risk factors of pneumococcus infection in the community of healthy Vietnamese children?

Study Overview

• Status: Active, not recruiting
• Conditions: Streptococcus Pneumonia

• Study Type: Observational
• Enrollment (Estimated): 800

Contacts and Locations

Study Locations

• Vietnam
  • Da Nang, Vietnam
    • VNVC Da Nang
  • Hanoi, Vietnam
    • VNVC Icon4 Cau Giay
  • Ho Chi Minh City, Vietnam
    • VNVC Tan Phu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Children from 6 months and 5 years old who visit the Vietnam Vaccination Center (VNVC) system in Hanoi, Danang and Ho Chi Minh city for vaccination services

Description

Inclusion Criteria:

• Children between 6 months and 5 years

Exclusion Criteria:

• Children with chronic diseases (including immunologic diseases, neoplastic disorders, renal, cardiac, hepatic, or hematologic diseases, broncho dysplasia, Down syndrome, chronic otitis media with effusion)
• Children with acute/chronic upper or lower respiratory tract infection
• Children have used antibiotics within 1 week prior to entering the study

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Children between 6 months and 5 years

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of pneumococcal carriage in the nasopharynx in children from 6 months to 5 years old in the Vietnamese community	Pneumococcal prevalence in children by age group, sex and geographical area	Day 0 after recruitment
Serotype distribution of pneumococcal strains in Vietnamese children from 6 months to 5 years old in the community	The number of carrier individuals by serotype will be determined for age group, sex and geographical area	Day 0 after recruitment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Risk factors associated with pneumococcal carriage	Gender, age, urban vs rural setting, environmental, lifestyle factors and other factors will be analyzed.	Day 0 after recruitment

Collaborators and Investigators

• Sponsor: Tam Anh Research Institute
• Collaborators: Pfizer

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2024
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: October 9, 2024
• First Submitted That Met QC Criteria: October 9, 2024
• First Posted (Actual): October 15, 2024

Study Record Updates

• Last Update Posted (Actual): April 13, 2025
• Last Update Submitted That Met QC Criteria: April 9, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Lung Diseases; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Streptococcal Infections; Pneumococcal Infections; Pneumonia, Bacterial; Pneumonia; Pneumonia, Pneumococcal
• Other Study ID Numbers: TA0002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No