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NCT06531538 · ClinicalTrials.gov registry record · Phase 2
A Study to Learn About How a New Pneumococcal Vaccine Works in Children
A Phase 2 study of Pneumococcal Disease, sponsored by Pfizer.
- Completed
- Registry status
- Phase 2
- Development phase
- 225
- Enrollment target
- 20
- Study locations
NCT06531538: Completed Phase 2 study of Pneumococcal Disease, sponsored by Pfizer.
NCT06531538 is a Phase 2 study of Pneumococcal Disease that has completed, run by Pfizer. The registered enrollment target is 225 participants, below the 512-participant average among 3 other Pneumococcal Disease trials with a reported enrollment target (56% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06531538, a Phase 2 study of Pneumococcal Disease, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 225 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to learn about the safety, tolerability and immune effects of a pneumococcal vaccine in toddlers. Participants will take part in this study for approximately 6 or 8 months depending on which group they are assigned to. During this time participants will have 2 clinic visits and 1 phone visit for the 1-Dose group, or 3 clinic visits and 1 phone visit for the 2-Dose group. At these clinic visits, participants will be asked if any side effects were experienced. The participants will also have to give blood samples during some clinic visits.
Primary Outcome
Prespecified local reactions (redness, swelling, and pain at the injection site) after each dose
Conditions Studied
Interventions
- BIOLOGICAL PG4
- BIOLOGICAL 20-valent pneumococcal conjugate vaccine (20vPnC)
Study Locations (20)
North Carolina
- Atrium Health - Strive Vaccine Research Clinic - Charlotte
- Atrium Health-Myers Park - Charlotte
- Duke Vaccine and Trials Unit - Durham
- Durham Pediatrics at North Duke Street - Durham
- Duke University - Durham
- Atrium Health-Matthews - Matthews
Georgia
- Tekton Research, LLC. - Chamblee
- Javara - Privia Medical Group Georgia - Fayetteville - Fayetteville
- Rophe Adult and Pediatric Medicine/SKYCRNG - Union City
Louisiana
- Louisiana State University Health Sciences Shreveport - Fairfield avenue - Shreveport
- Louisiana State University Health Sciences Shreveport - Shreveport
- Ochsner/LSU Health Ambulatory Care Center - Shreveport
Maryland
- University of Maryland, Baltimore - Institutional Review Board - Baltimore
- University of Maryland, Baltimore, Center for Vaccine Development and Global Health - Baltimore
- The Pediatric Center - Columbia
District of Columbia
- Emerson Clinical Research Institute - Washington D.C.
Florida
- Bio-Medical Research LLC - Miami
Iowa
- The Iowa Clinic - Ankeny
Ohio
- Senders Pediatrics - South Euclid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 225 participants |
| Start Date | 2024-07-30 |
| Est. Completion | 2026-02-09 |
| Phase | Phase 2 |
What the finished NCT06531538 record still lists
NCT06531538 is an interventional study that assigns participants to a tested intervention. The registered 225 participants enrollment target is mid-sized for trials with a published cap, below the 512-participant average among 3 other Pneumococcal Disease trials with a reported enrollment target (56% lower).
The record links to 1 condition, with Pneumococcal Disease appearing as the primary indexed condition, and to 2 interventions - of which PG4 is the first listed.
NCT06531538 names 20 study sites across 9 states, led by North Carolina, Georgia, Louisiana.
Frequently Asked Questions
What is clinical trial NCT06531538 about?
NCT06531538 is a clinical study titled "A Study to Learn About How a New Pneumococcal Vaccine Works in Children". The purpose of this study is to learn about the safety, tolerability and immune effects of a pneumococcal vaccine in toddlers. Participants will take part in this study for approximately 6 or 8 months depending on which group they are assigned to. During this time participants will have 2 clinic vi...
What is the current status of trial NCT06531538?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 225 participants. The study started on 2024-07-30. Estimated completion is 2026-02-09.
What conditions does trial NCT06531538 study?
This clinical trial studies the following conditions: Pneumococcal Disease.
What interventions are being tested in trial NCT06531538?
The interventions under investigation include: PG4 (BIOLOGICAL), 20-valent pneumococcal conjugate vaccine (20vPnC) (BIOLOGICAL).
Who is sponsoring clinical trial NCT06531538?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06531538 being conducted?
This trial has 20 study locations across District of Columbia, Florida, Georgia, Iowa, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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