Streptococcus PneumoniaNCT06638333
Prevalence and Serotype Distribution of Streptococcus Pneumoniae in Healthy Vietnamese Children From 6 Months to 5 Years Old
An observational study of Streptococcus Pneumonia, run by Tam Anh Research Institute at 3 sites in Vietnam.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Streptococcus Pneumonia
- How many people
- 800 participants
- Where
- 3 sitesVietnam
- Study dates
- 1 Nov 2024to 26 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 5 years
- All sexes
- Healthy volunteers accepted
- Child
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
Who may be able to join
- Children between 6 months and 5 years
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Vietnam3 sites
VNVC Da Nang
Da Nang
VNVC Icon4 Cau Giay
Hanoi
VNVC Tan Phu
Ho Chi Minh City
About this study
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.
Read more
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
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Children between 6 months and 5 years | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Day 0 after recruitment
Secondary outcomes (1)
Risk factors associated with pneumococcal carriage
Gender, age, urban vs rural setting, environmental, lifestyle factors and other factors will be analyzed.
Measured: Day 0 after recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start1 Nov 2024
- Primary completion2 Mar 2025
- Study completion26 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Streptococcus PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tam Anh Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06638333
- Sponsor's protocol ID
- TA-0002
- Status last verified
- Mar 2025
- First submitted
- 9 Oct 2024
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Serotype Distribution of Streptococcus Pneumoniae in Healthy Vietnamese Children From 6 Months to 5 Years Old
- ClinicalTrials.gov ID
- NCT06638333
- Acronym / sponsor ID
- TA-0002
- Conditions
- Streptococcus Pneumonia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- Tam Anh Research InstituteUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 2 Mar 2025 (actual)
- Study completion
- 26 Dec 2025 (actual)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children between 6 months and 5 years | – | – |
Who may qualify
- Ages
- 6 months to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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
Key inclusion criteria (1 listed)
- Children between 6 months and 5 years
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
1 secondary outcome
Risk factors associated with pneumococcal carriage
Time frame: Day 0 after recruitment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Streptococcus Pneumonia, run by Tam Anh Research Institute at 3 sites in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.