PCV13 Impact on Pneumococcal Nasopharyngeal Carriage Study (NCT05114902) | Clinical Trial Compass
UnknownNot Applicable
PCV13 Impact on Pneumococcal Nasopharyngeal Carriage Study
Philippines451 participantsStarted 2021-11-24
Plain-language summary
Prospective, observational, hospital based, nasopharyngeal carriage (NPC), vaccine effectiveness study Comparisons will be made in Filipino children, aged 8 weeks to ≤60 months of age at enrollment, who have been hospitalized with a radiologically-confirmed, community-acquired pneumonia (CAP).
Who can participate
Age range
8 Weeks – 60 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Child 8 weeks to ≤60 months of age
. Resident of the National Capital Region (NCR) or Region X-XIII
. Child admitted with a medical diagnosis of clinical CAP based on history and physical exam
. Written informed consent obtained from a parent or legal guardian
. At SPMC site, child must have received at least 1 dose of PCV13 given at \<12 months based on history-taking
. For Phase B at PCMC site, child must have received at least 1 dose of PCV13 given at \<12 months based on history-taking
Exclusion criteria
. Children with a known primary or secondary immunodeficiency
. Child with a contraindication to doing a nasopharyngeal swab which may include, but is not limited to: dyscrasias, coagulation disorders, or other diseases (e.g., hemophilia, purpura), presence of craniofacial abnormalities32
. For Phase A at PCMC site, child with any PCV in the past based on history-taking
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
S. pneumoniae serotypes
Timeframe: Upon Admission
2
S. pneumoniae serotypes Upon Admission
Timeframe: Upon Admission
3
Antimicrobial resistance rate of S. pneumoniae
Timeframe: Upon Admission
4
Antimicrobial resistance rate of S. pneumoniae
Timeframe: Upon Admission
Trial details
NCT IDNCT05114902
SponsorAsian Foundation for Tropical Medicine Inc.