An observational study in Pneumococcal Carriage, sponsored by University of Central Florida. Recruiting at 1 site in United States. Open to participants aged 28 Days to 48 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-06.
Sponsored by University of Central Florida · Observational
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.
University of Central Florida is the lead sponsor of 99 studies on the registry; 40 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Have a parent or legal guardian who:
Exclusion Criteria:
60 healthy children under 4 years of age (30 children aged 0-1 years, 30 children aged 2-4 years) residing in Orlando, Florida.
Other: Oropharyngeal (OP) swab
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.
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.
Time frame: 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.
Time frame: One year
Evaluate the feasibility and scalability of expanding the study to a larger sample size
Time frame: One year
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.
Time frame: 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.
Time frame: 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.
Time frame: One year
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Central Florida