Pneumococcal CarriageNCT07748832
Pneumococcal Carriage Duration
An observational study of Pneumococcal Carriage, run by University of Central Florida at 1 site in United States.
Trial summary
Streptococcus pneumoniae (SPN) remains a leading cause of respiratory disease in young children despite widespread vaccination. Understanding the duration of pneumococcal carriage, patterns of co-colonization, and the influence of viral infections and the respiratory microbiome is essential to evaluate next-generation… Read more about this study
- Who is it for?
- Ages 28 days to 48 monthsHealthy volunteers can take part
- Conditions the study is for
- Pneumococcal Carriage
- What is being tested?
- Oropharyngeal (OP) swab
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jul 2026to Jul 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 28 days to 48 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: The study will enroll 60 healthy children under 4 years of age (30 aged 0-1 year, 30 aged 2-4 years) residing in Orlando, Florida. Children must be free of chronic or immuno-compromising conditions. Participants will be recruited from the community, pediatric clinics, and existing registries.
Who may be able to join
- Are older than 28 days and under 4 years of age at the time of enrollment.
- Have a parent or legal guardian who:
- Provides written informed consent.
- Is able to read and speak English or Spanish.
- Agrees to comply with all study procedures, including completion of questionnaires and biweekly oropharyngeal (OP) swab collections from the child for a period of 12 months.
Who cannot join
- History of chronic medical conditions or immunocompromising conditions that may influence pneumococcal carriage or study participation, such as:
- cystic fibrosis
- cerebral palsy
- neuromuscular disorders
- congenital heart disease
- known congenital or acquired immunodeficiencies
- sickle cell disease
- undergoing immunosuppressive therapy (e.g., systemic corticosteroids ≥2 mg/kg/day for ≥14 days, chemotherapy, biologics)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Central Florida
Orlando, Florida, 32827
Dr. Amoy Fraser, PhD, 407-266-8742, Amoy.Fraser@UCF.edu
Aniya Barclay, MS, 407-266-8742, Aniya.Barclay@UCF.edu
About this study
Official title: NIS103487 Duration of Streptococcus Pneumoniae Carriage in U.S. Children Under Five: A Pilot Longitudinal Study
Streptococcus pneumoniae (SPN) remains a leading cause of respiratory disease in young children despite widespread vaccination. Understanding the duration of pneumococcal carriage, patterns of co-colonization, and the influence of viral infections and the respiratory microbiome is essential to evaluate next-generation pneumococcal vaccines and inform public health strategies. Current data on Streptococcus pneumoniae carriage dynamics are limited in U.S. pediatric populations. This study aims to generate updated estimates of Streptococcus pneumoniae colonization and explore microbial interactions using high-resolution longitudinal sampling and genomic methods.
- Conditions
- Pneumococcal Carriage
- Being tested
- Oropharyngeal (OP) swab
- Keywords
- Pneumococcal Carriage, Children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oropharyngeal (OP) swabOther
At each study visit, a double-tipped OP swab will be collected by trained clinical research staff. All swabs will be collected using a standard protocol. There will be 26 total study visits over the course of one year.
| Study group | Role | What they receive |
|---|---|---|
| Main Cohort | 60 healthy children under 4 years of age (30 children aged 0-1 years, 30 children aged 2-4 years) residing in Orlando, Florida. Receives: Other: Oropharyngeal (OP) swab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimate the age- and serotype-specific carriage duration of Streptococcus pneumoniae in children aged 0-4 years.
Respiratory samples will be tested to determine whether Streptococcus pneumoniae (pneumococcus) is present using standard laboratory methods and genetic testing. If found, the bacteria will be genetically analyzed to identify its type (serotype) and compare it with other strains. Researchers will measure when a child first becomes colonized, when the bacteria are cleared (after two negative tests), how long colonization lasts, and how quickly new colonization occurs. Genetic analysis will determine whether the same strain persists or a new strain is acquired.
Measured: One year
Estimate the age- and serotype-specific co-colonization rates of S. pneumoniae in children aged 0-4 years.
Respiratory samples will be tested to determine whether Streptococcus pneumoniae (pneumococcus) is present with other pneumococcal intra-subject lineages (ISL) using standard laboratory methods and genetic testing. If found, the bacteria will be genetically analyzed to identify the different types (serotype) and how many there are.
Measured: One year
Evaluate the feasibility and scalability of expanding the study to a larger sample size
Measured: One year
Secondary outcomes (3)
Determine which viral and bacterial pathogens are present in respiratory specimens collected from enrolled children
Respiratory samples will be tested for common viruses and bacteria using advanced laboratory methods. Researchers will also record whether participants have symptoms or are carrying these bacteria without feeling sick. They will track when a participant first acquires a new respiratory virus (one that was not detected at the previous visit) and calculate how often new infections occur over time, including comparisons by age group.
Measured: One year
Assessment of study methodologies
Researchers will compare different laboratory methods ( to see how well they detect Streptococcus pneumoniae and identify its type. They will also evaluate whether collecting samples every two weeks or once a month provides better information on bacterial carriage, new infections, and missing data. The study will compare different methods for analyzing the respiratory microbiome (the community of bacteria in the airways) and use computer models to determine whether microbiome patterns can predict pneumococcal carriage. Finally, researchers will compare the costs and practicality of different sampling schedules, collection methods, and laboratory tests to help guide future studies.
Measured: One year
To identify carriage of pneumococcal serotypes among participants in the context of PCV vaccine history.
The PI will identify the carriage of vaccine serotypes (VT) included in the most recent PCV administered to each participant. This analysis will compare VT versus NVT carriage prevalence, stratified by age group, vaccine, and time since vaccination.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2026
- Study start21 Jul 2026
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumococcal CarriageStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Central Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Dr. Taj Azarian, PhD, Principal investigator, University of Central Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07748832
- Sponsor's protocol ID
- STUDY00008626
- Status last verified
- Aug 2026
- First submitted
- 27 Jul 2026
- Last updated
- 6 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NIS103487 Duration of Streptococcus Pneumoniae Carriage in U.S. Children Under Five: A Pilot Longitudinal Study
- ClinicalTrials.gov ID
- NCT07748832
- Acronym / sponsor ID
- STUDY00008626
- Conditions
- Pneumococcal Carriage
- Keywords
- Pneumococcal Carriage, Children
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Central FloridaUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 21 Jul 2026 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 6 Aug 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.
Streptococcus pneumoniae (SPN) remains a leading cause of respiratory disease in young children despite widespread vaccination. Understanding the duration of pneumococcal carriage, patterns of co-colonization, and the influence of viral infections and the respiratory microbiome is essential to evaluate next-generation pneumococcal vaccines and inform public health strategies. Current data on Streptococcus pneumoniae carriage dynamics are limited in U.S. pediatric populations. This study aims to generate updated estimates of Streptococcus pneumoniae colonization and explore microbial interactions using high-resolution longitudinal sampling and genomic methods.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Main Cohort | – | Other: Oropharyngeal (OP) swab60 healthy children under 4 years of age (30 children aged 0-1 years, 30 children aged 2-4 years) residing in Orlando, Florida. |
Who may qualify
- Ages
- 28 days to 48 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The study will enroll 60 healthy children under 4 years of age (30 aged 0-1 year, 30 aged 2-4 years) residing in Orlando, Florida. Children must be free of chronic or immuno-compromising conditions. Participants will be recruited from the community, pediatric clinics, and existing registries.
Key inclusion criteria (5 listed)
- Are older than 28 days and under 4 years of age at the time of enrollment.
- Have a parent or legal guardian who:
Key exclusion criteria (8 listed)
- History of chronic medical conditions or immunocompromising conditions that may influence pneumococcal carriage or study participation, such as:
- cystic fibrosis
- cerebral palsy
- neuromuscular disorders
- congenital heart disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oropharyngeal (OP) swabAt each study visit, a double-tipped OP swab will be collected by trained clinical research staff. All swabs will be collected using a standard protocol. There will be 26 total study visits over the course of one year. | Other | Main Cohort |
Primary outcome
Estimate the age- and serotype-specific carriage duration of Streptococcus pneumoniae in children aged 0-4 years.
Time frame: One year
Respiratory samples will be tested to determine whether Streptococcus pneumoniae (pneumococcus) is present using standard laboratory methods and genetic testing. If found, the bacteria will be genetically analyzed to identify its type (serotype) and compare it with other strains. Researchers will measure when a child first becomes colonized, when the bacteria are cleared (after two negative tests), how long colonization lasts, and how quickly new colonization occurs. Genetic analysis will determine whether the same strain persists or a new strain is acquired.
Estimate the age- and serotype-specific co-colonization rates of S. pneumoniae in children aged 0-4 years.
Time frame: One year
Respiratory samples will be tested to determine whether Streptococcus pneumoniae (pneumococcus) is present with other pneumococcal intra-subject lineages (ISL) using standard laboratory methods and genetic testing. If found, the bacteria will be genetically analyzed to identify the different types (serotype) and how many there are.
Evaluate the feasibility and scalability of expanding the study to a larger sample size
Time frame: One year
3 secondary outcomes
Determine which viral and bacterial pathogens are present in respiratory specimens collected from enrolled children
Time frame: One year
Assessment of study methodologies
Time frame: One year
To identify carriage of pneumococcal serotypes among participants in the context of PCV vaccine history.
Time frame: One year
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 6 Aug 2026.
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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.
Dr. Taj Azarian, PhD principal investigator
University of Central Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumococcal Carriage, run by University of Central Florida at 1 site in United States.
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 5 inclusion and 8 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 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 Dr. Amoy Fraser, PhD (407-266-8742, Amoy.Fraser@UCF.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimate the age- and serotype-specific carriage duration of Streptococcus pneumoniae in children aged 0-4 years. (time frame: One year). The study lists 3 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 6 Aug 2026.