Recruiting

Observational Study

Sponsor:

University of Central Florida

Code:

NCT07748832

Conditions

Pneumococcal Carriage

Eligibility Criteria

Sex: All

Age: 0 - 4

Healthy Volunteers: Accepted

Interventions

Oropharyngeal (OP) swab

Study Details

Brief 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 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

Study ID

NCT07748832

Start date

Jul 21, 2026

Status verified date

Aug, 2026

Completion date

Jul, 2027

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 4

Healthy Volunteers: Accepted

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:

1. Provides written informed consent.
2. Is able to read and speak English or Spanish.
3. 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)

Study Design

Enrollment

60 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • Estimate the age- and serotype-specific carriage duration of Streptococcus pneumoniae in children aged 0-4 years. [ Time Frame: One year ]
  • Estimate the age- and serotype-specific co-colonization rates of S. pneumoniae in children aged 0-4 years. [ Time Frame: One year ]
  • Evaluate the feasibility and scalability of expanding the study to a larger sample size [ Time Frame: One year ]

Central Contacts and Locations

Central contacts

Dr. Amoy Fraser, PhD

407-266-8742Amoy.Fraser@UCF.edu

Aniya Barclay, MS

407-266-8742Aniya.Barclay@UCF.edu

Locations

University of Central Florida

Recruiting

Orlando, Florida, United States, 32827

Contacts

Dr. Amoy Fraser, PhD

407-266-8742Amoy.Fraser@UCF.edu

Aniya Barclay, MS

407-266-8742Aniya.Barclay@UCF.edu

More Information

Sponsor

University of Central Florida

Last update posted

Aug 6, 2026

Last verified

Aug, 2026

Keywords

  • Pneumococcal Carriage
  • Children

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Central Florida on 2026-08-06.