Pneumococcal Carriage Duration

NCT07748832 | Recruiting

• 1 other identifier: STUDY00008626
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

Pneumococcal Carriage; Children

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  One year

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

  One year

Secondary Outcomes (3)

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

  One year

• Assessment of study methodologies

  One year

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

  One year

Study Arms (1)

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.

Other: Oropharyngeal (OP) swab

Interventions

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.

Main Cohort

Eligibility Criteria

• Age: 28 Days - 48 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Central Florida: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

University of Central Florida

Orlando, Florida, 32827, United States

RECRUITING

Study Officials

• Dr. Taj Azarian, PhD

  University of Central Florida

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. Amoy Fraser, PhD

CONTACT

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

Aniya Barclay, MS

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2026
• First Posted: August 6, 2026
• Study Start: July 21, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: August 6, 2026

Record last verified: 2026-08

Locations

US (1)