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NCT Number: NCT07748832

Pneumococcal Carriage Duration

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.

Recruiting

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Key information

Age range

28 day–48 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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)

Treatment and study plan

Oropharyngeal (OP) swab

Other

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.

Primary outcomes

  1. 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.

  2. 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.

  3. Evaluate the feasibility and scalability of expanding the study to a larger sample size

    Time frame: One year

Secondary outcomes

  1. Determine which viral and bacterial pathogens are present in respiratory specimens collected from enrolled children

    Time frame: One year

    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.

  2. Assessment of study methodologies

    Time frame: One year

    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.

  3. To identify carriage of pneumococcal serotypes among participants in the context of PCV vaccine history.

    Time frame: One year

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Aniya Barclay, MS

CONTACT

[email protected]

407-266-8742

Dr. Amoy Fraser, PhD

CONTACT

[email protected]

407-266-8742

Sponsors and collaborators

Lead sponsor

University of Central Florida

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study title

NIS103487 Duration of Streptococcus Pneumoniae Carriage in U.S. Children Under Five: A Pilot Longitudinal Study

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 6, 2026
Registry last updated
Aug 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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