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

NCT ID: NCT06638333

Last Updated: 2025-04-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

800 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-11-01

Study Completion Date

2025-06-30

Brief Summary

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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?

Detailed Description

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Conditions

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Streptococcus Pneumonia

Study Design

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Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Children between 6 months and 5 years

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

6 Months

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role collaborator

Tam Anh Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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VNVC Da Nang

Da Nang, , Vietnam

Site Status

VNVC Icon4 Cau Giay

Hanoi, , Vietnam

Site Status

VNVC Tan Phu

Ho Chi Minh City, , Vietnam

Site Status

Countries

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Vietnam

Other Identifiers

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TA0002

Identifier Type: -

Identifier Source: org_study_id

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