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

NCT06638333 | Active Not Recruiting

• 1 other identifier: TA0002
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 3

Brief Summary

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?

Conditions

Streptococcus Pneumonia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Risk factors associated with pneumococcal carriage

  Day 0 after recruitment

Study Arms (1)

Children between 6 months and 5 years

Eligibility Criteria

• Age: 6 Months - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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

You may qualify if:

• Children between 6 months and 5 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Tam Anh Research Institute: lead
• Pfizer: collaborator

Study Sites (3)

VNVC Da Nang

Da Nang, Vietnam

Location

VNVC Icon4 Cau Giay

Hanoi, Vietnam

Location

VNVC Tan Phu

Ho Chi Minh City, Vietnam

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Nasopharyngeal sample will be put in retention without analysis of human DNA

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2024
• First Posted: October 15, 2024
• Study Start: November 1, 2024
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: April 13, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

VN (3)