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OpenTrials
Completed

NCT Number: NCT06638333

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?

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Key information

Conditions

Streptococcus Pneumonia Infections Lung Diseases Pneumonia Respiratory Tract Diseases Respiratory Tract Infections

Age range

6 month–5 year

Sex eligibility

All sexes

Study type

Observational

Primary location

VNVC Da Nang, Da Nang, Vietnam

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Prevalence of pneumococcal carriage in the nasopharynx in children from 6 months to 5 years old in the Vietnamese community

    Time frame: Day 0 after recruitment

    Pneumococcal prevalence in children by age group, sex and geographical area

  2. Serotype distribution of pneumococcal strains in Vietnamese children from 6 months to 5 years old in the community

    Time frame: Day 0 after recruitment

    The number of carrier individuals by serotype will be determined for age group, sex and geographical area

Secondary outcomes

  1. Risk factors associated with pneumococcal carriage

    Time frame: Day 0 after recruitment

    Gender, age, urban vs rural setting, environmental, lifestyle factors and other factors will be analyzed.

Sponsors and collaborators

Lead sponsor

Tam Anh Research Institute

Other

Collaborators

  • Pfizer

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 15, 2024
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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