Nasopharyngeal Carriage of Streptococcus PneumoniaeMY-PNEUMO2NCT07545876
Pneumococcal Carriage, Serotypes, and Antibiotic Resistance in Malaysian Children: A Multi-Centre Study
An observational study of Nasopharyngeal Carriage of Streptococcus Pneumoniae, run by IMU University, Malaysia at 4 sites in Malaysia.
Trial summary
The goal of this observational study is to determine the prevalence, serotype distribution, and antimicrobial resistance patterns of nasopharyngeal carriage of Streptococcus pneumoniae in Malaysian children aged ≤5 years following the implementation of pneumococcal conjugate vaccines (PCVs). Read more about this study
- Who is it for?
- Ages 0 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Nasopharyngeal Carriage of Streptococcus Pneumoniae
- How many people
- 600 participants
- Where
- 4 sitesMalaysia
- Study dates
- 9 Apr 2026to 30 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 0 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: All children meeting the inclusion criteria, attending GP clinics, the outpatient department or admitted as hospital inpatients in sentinel teaching hospital sites. Male and female patients from the three major ethnic groups (Malay, Chinese, and Indian) will be recruited from each sentinel site.
Who may be able to join
- Children aged ≤5 years (0-60 months)
- Hemodynamically stable at the time of sampling
- Parent/guardian provides written informed consent
- Resident in Malaysia for at least 3 months prior to enrolment
Who cannot join
- Current or recent antibiotic use within the last 30 days
- Known to have an immunodeficiency or currently on chemotherapy, or post-transplant recipients or on high-dose steroids (defined as >20mg/day or 2mg/kg/day of Prednisolone for 2 weeks or more)
- Has nasal surgery
- Refusal of consent by parent or guardian
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Malaysia4 sites, 4 recruiting
- Recruiting
KMI Taman Desa Medical Centre
Kuala Lumpur, Kuala Lumpur, 58100
Lim Menq Keong, +60176044995, mktor17@gmail.com
Lim Menq Keong
- Recruiting
CMH Specialist Hospital
Seremban, Negeri Sembilan, 70200
Chew Joling, +60126563661, cjoling17@gmail.com
Chew Joling
- Recruiting
Hospital Tuanku Jaafar
Seremban, Negeri Sembilan, 70300
David Ng Chun-Ern, +60178806188, davidngce@gmail.com
David Ng Chun-Ern
- Recruiting
Avisena Women's & Children Specialist Hospital
Shah Alam, Selangor, 40000
Tan Eng Kian, MBBS, +60122839516, ektan369@gmail.com
Tan Eng Kian
About this study
Official title: Nasopharyngeal Carriage, Serotype Distribution, and Antimicrobial Resistance Profile of Streptococcus Pneumoniae in Malaysian Children: A Prospective Multi-Centre Study
The goal of this observational study is to determine the prevalence, serotype distribution, and antimicrobial resistance patterns of nasopharyngeal carriage of Streptococcus pneumoniae in Malaysian children aged ≤5 years following the implementation of pneumococcal conjugate vaccines (PCVs). The study focuses on healthy and mildly symptomatic male and female children aged 0-60 months recruited from urban and semi-urban settings in Kuala Lumpur, Selangor, and Negeri Sembilan.
The main questions it aims to answer are:
Read more
- What is the overall and age-specific prevalence of nasopharyngeal pneumococcal carriage among children aged ≤5 years in Malaysia?
- What are the circulating serotypes and antimicrobial resistance (AMR) profiles of pneumococcal isolates, and how are they associated with vaccination status and PCV valency coverage?
Researchers will compare carriage prevalence, serotype distribution (vaccine-type vs non-vaccine-type), and antimicrobial resistance patterns across different states, vaccination statuses, and socioeconomic backgrounds to determine differences in transmission dynamics and potential serotype replacement patterns.
Participants will:
- Undergo a nasopharyngeal swab collection for pneumococcal detection.
- Provide demographic and vaccination history information through a standardised case report form completed with parental/guardian consent.
- Have their samples analysed using bacterial culture, antimicrobial susceptibility testing, and whole-genome sequencing (WGS) for serotyping and resistance profiling.
Read the detailed description
Nasopharyngeal colonisation with Streptococcus pneumoniae (Spn) is common in children under five and serves as a reservoir for transmission, a precursor to disease, and an indicator of circulating serotypes within communities. While often asymptomatic, pneumococcal carriage contributes to the development of respiratory tract infections and the spread of antimicrobial resistance (AMR). In Malaysia, pneumonia remains the third leading principal cause of death among children under five, and pneumococcal carriage is central to its pathogenesis. Spn is one of the primary bacterial agents responsible for childhood pneumonia and other serious infections, including otitis media, bacteremia, and meningitis. However, prior to causing disease, S. pneumoniae typically colonises the nasopharynx, particularly in young children, making nasopharyngeal carriage a key epidemiological marker for disease risk, serotype circulation, and transmission dynamics.
The background of this study is rooted in the recent evolution of Malaysia's National Immunisation Programme (NIP). While pneumococcal conjugate vaccines (PCVs) have been available in the private sector for years, the Malaysian government officially introduced the vaccine into the NIP in December 2020, initially using the 10-valent vaccine (PCV10) before transitioning to the 13-valent version (PCV13) in 2023. This transition created a unique epidemiological landscape where different cohorts of children have received different vaccine formulations. Current surveillance in Malaysia has largely focused on invasive disease cases in hospital settings, leaving a significant "data gap" regarding how the vaccine is affecting the general population of children who carry the bacteria. Understanding this community carriage is essential because it reveals "serotype replacement"-a phenomenon where non-vaccine strains emerge to fill the ecological niche left by the strains targeted by the vaccine. Furthermore, the rising threat of antimicrobial resistance (AMR) in S. pneumoniae complicates treatment, as many strains are becoming less sensitive to common antibiotics like penicillin and erythromycin.
The primary objective of this prospective, multi-centre, cross-sectional study is to establish a comprehensive baseline of pneumococcal carriage, serotype distribution, and antimicrobial resistance patterns among Malaysian children aged five years and below. By adopting a prospective cross-sectional design, the research aims to determine the point prevalence of carriage in both healthy and mildly symptomatic children across a specific temporal snapshot. Utilizing advanced laboratory techniques, the study intends to identify which specific serotypes are circulating in the community and evaluate the extent to which current vaccines (PCV13) cover these strains. Additionally, the study seeks to map the AMR profiles of these isolates to understand how resistance genes are distributed across different serotypes and geographic locations. A secondary but vital objective is to compare these findings across different urban and semi-urban settings in Kuala Lumpur, Selangor, and Negeri Sembilan to identify socioeconomic or regional variations in transmission.
To achieve these goals, the study will recruit 600 children from diverse settings, including daycare centers and outpatient clinics, ensuring the data reflects the community rather than just the sickest patients in hospitals. Each participant will undergo a nasopharyngeal swab collection, and a standardized case report form will be used to record their demographic details and precise vaccination history. The collected samples will undergo rigorous analysis at the IMU Central Laboratory, employing both traditional bacterial culture and state-of-the-art Whole-Genome Sequencing (WGS). WGS allows for high-resolution serotyping and the detection of specific resistance markers, providing a level of detail that traditional methods cannot reach. By linking the genomic data of the bacteria with the vaccination status of the children within this prospective framework, the study will provide the evidence-based insights necessary for health authorities to decide on future strategies, such as the potential implementation of higher-valent vaccines like PCV15 or PCV20.
- Keywords
- Streptococcus pneumoniae, nasopharyngeal carriage
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 |
|---|---|---|
| Pneumococcal Carriage Group | A single cohort of 600 children aged 0 to 60 months (≤5 years) recruited from urban and semi-urban community settings in Kuala Lumpur, Selangor, and Negeri Sembilan. This group includes healthy children and those with mild, self-limiting symptoms attending daycare centres, outpatient paediatric clinics, and community healthcare facilities. All participants will undergo a one-time nasopharyngeal swab collection to determine the prevalence, serotype distribution, and antimicrobial resistance patterns of Streptococcus pneumoniae carriage. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence rate of nasopharyngeal pneumococcal carriage among children aged ≤5 years.
The presence or absence of nasopharyngeal pneumococcal carriage will be determined using standard bacteriological culture methods. Confirmed S. pneumoniae isolates will be processed for DNA extraction, and the prevalence rate will be calculated as the proportion of children carrying the bacteria within the total sampled population of 600.
Measured: 18 months
Secondary outcomes (1)
Genomic profile of pneumococcal isolates using Whole-Genome Sequencing (WGS)
Spn isolates will be sequenced using a Whole-Genome Sequencing (WGS) platform (Illumina) to determine the circulating serotypes and sequence types (MLST). The genomic data will also be analyzed to identify resistance genes and susceptibility patterns. This will allow for an assessment of vaccine-type (VT) versus non-vaccine-type (NVT) distribution and the coverage provided by PCV13, PCV15, and PCV20.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start9 Apr 2026
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Nasopharyngeal Carriage of Streptococcus PneumoniaeStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IMU University, Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nurul Hanis Ramzi, IMU University, Malaysia
- Investigators
- Nurul Hanis Ramzi, Principal investigator, IMU University, Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07545876
- Sponsor's protocol ID
- 4.12/JCM-322/2025
- Other IDs
- 100064489
- Acronym
- MY-PNEUMO2
- Status last verified
- Jun 2026
- First submitted
- 16 Apr 2026
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Adegbola RA, DeAntonio R, Hill PC, Roca A, Usuf E, Hoet B, Greenwood BM. Carriage of Streptococcus pneumoniae and other respiratory bacterial pathogens in low and lower-middle income countries: a systematic review and meta-analysis. PLoS One. 2014 Aug 1;9(8):e103293. doi: 10.1371/journal.pone.0103293. eCollection 2014.
PubMed 25084351Bogaert D, van Belkum A, Sluijter M, Luijendijk A, de Groot R, Rumke HC, Verbrugh HA, Hermans PW. Colonisation by Streptococcus pneumoniae and Staphylococcus aureus in healthy children. Lancet. 2004 Jun 5;363(9424):1871-2. doi: 10.1016/S0140-6736(04)16357-5.
PubMed 15183627Zakiyah N, Insani WN, Suwantika AA, van der Schans J, Postma MJ. Pneumococcal Vaccination for Children in Asian Countries: A Systematic Review of Economic Evaluation Studies. Vaccines (Basel). 2020 Jul 30;8(3):426. doi: 10.3390/vaccines8030426.
PubMed 32751569Sallam M, Abbadi J, Natsheh A, Ababneh NA, Mahafzah A, Ozkaya Sahin G. Trends in Antimicrobial Drug Resistance of Streptococcus pneumoniae Isolates at Jordan University Hospital (2000(-)2018). Antibiotics (Basel). 2019 Apr 12;8(2):41. doi: 10.3390/antibiotics8020041.
PubMed 31013803Siira L, Vestrheim DF, Winje BA, Caugant DA, Steens A. Antimicrobial susceptibility and clonality of Streptococcus pneumoniae isolates recovered from invasive disease cases during a period with changes in pneumococcal childhood vaccination, Norway, 2004-2016. Vaccine. 2020 Jul 22;38(34):5454-5463. doi: 10.1016/j.vaccine.2020.06.040. Epub 2020 Jun 30.
PubMed 32616324Aspa J, Rajas O, de Castro FR. Pneumococcal antimicrobial resistance: therapeutic strategy and management in community-acquired pneumonia. Expert Opin Pharmacother. 2008 Feb;9(2):229-41. doi: 10.1517/14656566.9.2.229.
PubMed 18201146
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nasopharyngeal Carriage, Serotype Distribution, and Antimicrobial Resistance Profile of Streptococcus Pneumoniae in Malaysian Children: A Prospective Multi-Centre Study
- ClinicalTrials.gov ID
- NCT07545876
- Acronym / sponsor ID
- MY-PNEUMO2 / 4.12/JCM-322/2025
- Keywords
- Streptococcus pneumoniae, nasopharyngeal carriage
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- IMU University, MalaysiaUniversity, hospital or other
- Study start
- 9 Apr 2026 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 22 Apr 2026 (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.
The goal of this observational study is to determine the prevalence, serotype distribution, and antimicrobial resistance patterns of nasopharyngeal carriage of Streptococcus pneumoniae in Malaysian children aged ≤5 years following the implementation of pneumococcal conjugate vaccines (PCVs). The study focuses on healthy and mildly symptomatic male and female children aged 0-60 months recruited from urban and semi-urban settings in Kuala Lumpur, Selangor, and Negeri Sembilan.
The main questions it aims to answer are:
- What is the overall and age-specific prevalence of nasopharyngeal pneumococcal carriage among children aged ≤5 years in Malaysia?
- What are the circulating serotypes and antimicrobial resistance (AMR) profiles of pneumococcal isolates, and how are they associated with vaccination status and PCV valency coverage?
Researchers will compare carriage prevalence, serotype distribution (vaccine-type vs non-vaccine-type), and antimicrobial resistance patterns across different states, vaccination statuses, and socioeconomic backgrounds to determine differences in transmission dynamics and potential serotype replacement patterns.
Participants will:
- Undergo a nasopharyngeal swab collection for pneumococcal detection.
- Provide demographic and vaccination history information through a standardised case report form completed with parental/guardian consent.
- Have their samples analysed using bacterial culture, antimicrobial susceptibility testing, and whole-genome sequencing (WGS) for serotyping and resistance profiling.
Detailed description
Nasopharyngeal colonisation with Streptococcus pneumoniae (Spn) is common in children under five and serves as a reservoir for transmission, a precursor to disease, and an indicator of circulating serotypes within communities. While often asymptomatic, pneumococcal carriage contributes to the development of respiratory tract infections and the spread of antimicrobial resistance (AMR). In Malaysia, pneumonia remains the third leading principal cause of death among children under five, and pneumococcal carriage is central to its pathogenesis. Spn is one of the primary bacterial agents responsible for childhood pneumonia and other serious infections, including otitis media, bacteremia, and meningitis. However, prior to causing disease, S. pneumoniae typically colonises the nasopharynx, particularly in young children, making nasopharyngeal carriage a key epidemiological marker for disease risk, serotype circulation, and transmission dynamics.
The background of this study is rooted in the recent evolution of Malaysia's National Immunisation Programme (NIP). While pneumococcal conjugate vaccines (PCVs) have been available in the private sector for years, the Malaysian government officially introduced the vaccine into the NIP in December 2020, initially using the 10-valent vaccine (PCV10) before transitioning to the 13-valent version (PCV13) in 2023. This transition created a unique epidemiological landscape where different cohorts of children have received different vaccine formulations. Current surveillance in Malaysia has largely focused on invasive disease cases in hospital settings, leaving a significant "data gap" regarding how the vaccine is affecting the general population of children who carry the bacteria. Understanding this community carriage is essential because it reveals "serotype replacement"-a phenomenon where non-vaccine strains emerge to fill the ecological niche left by the strains targeted by the vaccine. Furthermore, the rising threat of antimicrobial resistance (AMR) in S. pneumoniae complicates treatment, as many strains are becoming less sensitive to common antibiotics like penicillin and erythromycin.
The primary objective of this prospective, multi-centre, cross-sectional study is to establish a comprehensive baseline of pneumococcal carriage, serotype distribution, and antimicrobial resistance patterns among Malaysian children aged five years and below. By adopting a prospective cross-sectional design, the research aims to determine the point prevalence of carriage in both healthy and mildly symptomatic children across a specific temporal snapshot. Utilizing advanced laboratory techniques, the study intends to identify which specific serotypes are circulating in the community and evaluate the extent to which current vaccines (PCV13) cover these strains. Additionally, the study seeks to map the AMR profiles of these isolates to understand how resistance genes are distributed across different serotypes and geographic locations. A secondary but vital objective is to compare these findings across different urban and semi-urban settings in Kuala Lumpur, Selangor, and Negeri Sembilan to identify socioeconomic or regional variations in transmission.
To achieve these goals, the study will recruit 600 children from diverse settings, including daycare centers and outpatient clinics, ensuring the data reflects the community rather than just the sickest patients in hospitals. Each participant will undergo a nasopharyngeal swab collection, and a standardized case report form will be used to record their demographic details and precise vaccination history. The collected samples will undergo rigorous analysis at the IMU Central Laboratory, employing both traditional bacterial culture and state-of-the-art Whole-Genome Sequencing (WGS). WGS allows for high-resolution serotyping and the detection of specific resistance markers, providing a level of detail that traditional methods cannot reach. By linking the genomic data of the bacteria with the vaccination status of the children within this prospective framework, the study will provide the evidence-based insights necessary for health authorities to decide on future strategies, such as the potential implementation of higher-valent vaccines like PCV15 or PCV20.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pneumococcal Carriage Group | – | –A single cohort of 600 children aged 0 to 60 months (≤5 years) recruited from urban and semi-urban community settings in Kuala Lumpur, Selangor, and Negeri Sembilan. This group includes healthy children and those with mild, self-limiting symptoms attending daycare centres, outpatient paediatric clinics, and community healthcare facilities. All participants will undergo a one-time nasopharyngeal swab collection to determine the prevalence, serotype distribution, and antimicrobial resistance patterns of Streptococcus pneumoniae carriage. |
Who may qualify
- Ages
- 0 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- All children meeting the inclusion criteria, attending GP clinics, the outpatient department or admitted as hospital inpatients in sentinel teaching hospital sites. Male and female patients from the three major ethnic groups (Malay, Chinese, and Indian) will be recruited from each sentinel site.
Key inclusion criteria (4 listed)
- Children aged ≤5 years (0-60 months)
- Hemodynamically stable at the time of sampling
- Parent/guardian provides written informed consent
- Resident in Malaysia for at least 3 months prior to enrolment
Key exclusion criteria (4 listed)
- Current or recent antibiotic use within the last 30 days
- Known to have an immunodeficiency or currently on chemotherapy, or post-transplant recipients or on high-dose steroids (defined as >20mg/day or 2mg/kg/day of Prednisolone for 2 weeks or more)
- Has nasal surgery
- Refusal of consent by parent or guardian
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 rate of nasopharyngeal pneumococcal carriage among children aged ≤5 years.
Time frame: 18 months
The presence or absence of nasopharyngeal pneumococcal carriage will be determined using standard bacteriological culture methods. Confirmed S. pneumoniae isolates will be processed for DNA extraction, and the prevalence rate will be calculated as the proportion of children carrying the bacteria within the total sampled population of 600.
1 secondary outcome
Genomic profile of pneumococcal isolates using Whole-Genome Sequencing (WGS)
Time frame: 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Background: PubMed 25084351Adegbola RA, DeAntonio R, Hill PC, Roca A, Usuf E, Hoet B, Greenwood BM. Carriage of Streptococcus pneumoniae and other respiratory bacterial pathogens in low and lower-middle income countries: a systematic review and meta-analysis. PLoS One. 2014 Aug 1;9(8):e103293. doi: 10.1371/journal.pone.0103293. eCollection 2014.
- Background: PubMed 15183627Bogaert D, van Belkum A, Sluijter M, Luijendijk A, de Groot R, Rumke HC, Verbrugh HA, Hermans PW. Colonisation by Streptococcus pneumoniae and Staphylococcus aureus in healthy children. Lancet. 2004 Jun 5;363(9424):1871-2. doi: 10.1016/S0140-6736(04)16357-5.
- Background: PubMed 32751569Zakiyah N, Insani WN, Suwantika AA, van der Schans J, Postma MJ. Pneumococcal Vaccination for Children in Asian Countries: A Systematic Review of Economic Evaluation Studies. Vaccines (Basel). 2020 Jul 30;8(3):426. doi: 10.3390/vaccines8030426.
- Background: PubMed 31013803Sallam M, Abbadi J, Natsheh A, Ababneh NA, Mahafzah A, Ozkaya Sahin G. Trends in Antimicrobial Drug Resistance of Streptococcus pneumoniae Isolates at Jordan University Hospital (2000(-)2018). Antibiotics (Basel). 2019 Apr 12;8(2):41. doi: 10.3390/antibiotics8020041.
- Background: PubMed 32616324Siira L, Vestrheim DF, Winje BA, Caugant DA, Steens A. Antimicrobial susceptibility and clonality of Streptococcus pneumoniae isolates recovered from invasive disease cases during a period with changes in pneumococcal childhood vaccination, Norway, 2004-2016. Vaccine. 2020 Jul 22;38(34):5454-5463. doi: 10.1016/j.vaccine.2020.06.040. Epub 2020 Jun 30.
- Background: PubMed 18201146Aspa J, Rajas O, de Castro FR. Pneumococcal antimicrobial resistance: therapeutic strategy and management in community-acquired pneumonia. Expert Opin Pharmacother. 2008 Feb;9(2):229-41. doi: 10.1517/14656566.9.2.229.
- 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.
Nurul Hanis Ramzi principal investigator
IMU University, Malaysia
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nasopharyngeal Carriage of Streptococcus Pneumoniae, run by IMU University, Malaysia at 4 sites in Malaysia.
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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 9 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 4 sites in Malaysia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nurul Hanis Ramzi (+60173396532, nurulhanis@imu.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence rate of nasopharyngeal pneumococcal carriage among children aged ≤5 years. (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07545876, which also lists 6 linked publications.
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 9 Jun 2026.