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NCT06182124 · ClinicalTrials.gov registry record · Phase 1
A Study to Learn About the Safety and Immune Response of a New Pneumococcal Vaccine in Adults
A Phase 1 study of Pneumococcal Disease, sponsored by Pfizer.
- Active
- Registry status
- Phase 1
- Development phase
- 558
- Enrollment target
- 18
- Study locations
NCT06182124: Active Phase 1 study of Pneumococcal Disease, sponsored by Pfizer.
NCT06182124 is a Phase 1 study of Pneumococcal Disease that is active but no longer recruiting, run by Pfizer. The registered enrollment target is 558 participants, above the 401-participant average among 3 other Pneumococcal Disease trials with a reported enrollment target (39% higher). The trial reports 18 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06182124, a Phase 1 study of Pneumococcal Disease, is active but no longer recruiting, sponsored by Pfizer.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 558 participants
- Enrollment target
- 18
- Study locations
Study Summary
The purpose of this study is to learn about the safety and immune effects of a pneumococcal vaccine in adults. This vaccine can possibly provide protection against further pneumococcal disease. This study will happen in 4 stages: Stage 1 is seeking participants who are between 18 years to 49 years of age. The participants will receive 1 of 2 pneumococcal vaccine candidates (different formulations) or 20vPnC (Prevnar 20) as a single shot given into the upper arm muscle. Stage 2 will begin after participants have completed Stage 1, and a pneumococcal vaccine candidate has been decided. Stage 2 is seeking participants who are adults 50 years of age and older. The participants will receive the chosen pneumococcal vaccine candidate from Stage 1 or 20vPnC (Prevnar 20). The vaccines will be given as a single shot into the upper arm muscle. Stage 3 is seeking participants who are adults 50 years of age and older. The participants will receive the chosen pneumococcal vaccine candidate from Stage 1 or a licensed pneumococcal comparator vaccine. The vaccines will be given as a single shot into the upper arm muscle. Stage 4 is seeking participants who are adults 50 years of age and older. The participants will receive either one of three pneumococcal vaccine candidates or one of two licensed pneumococcal comparator vaccines. The vaccines will be given as a single shot into the upper arm muscle. Participants will take part in this study for about 6 months for Stage 1, Stage 3, and Stage 4 and 12 months for Stage 2. During this time participants will have from 2 to 4 clinic visits and 1 phone visit. At these clinic visits, participants will be asked if any side effects were experienced. The participants will also have to give blood samples during these clinic visits.
Primary Outcome
Prespecified local reactions (redness, swelling, and pain at the injection site) after vaccination
Conditions Studied
Interventions
- BIOLOGICAL 20-valent pneumococcal conjugate vaccine (20vPnC)
- BIOLOGICAL Multivalent Pneumococcal Vaccine - Formulation 1
- BIOLOGICAL Multivalent Pneumococcal Vaccine - Formulation 2
- BIOLOGICAL Licensed pneumococcal comparator vaccine
- BIOLOGICAL Multivalent Pneumococcal Vaccine - Formulation 3
Study Locations (18)
Texas
- Headlands Horizons LLC - Brownsville
- DM Clinical Research- Cyfair - Houston
- Clinical Trials of Texas, LLC dba Flourish Research - San Antonio
- IMA Clinical Research San Antonio - San Antonio
- Dynamed Clinical Research, LP d/b/a DM Clinical Research - Sugar Land
- DM Clinical Research - Tomball
- Dynamed Clinical Research, LP d/b/a DM Clinical Research - Tomball
Florida
- Alliance for Multispecialty Research, LLC - Doral
- Indago Research & Health Center, Inc - Hialeah
Tennessee
- AMR Clinical - Knoxville
- AMR Clinical - Knoxville
Georgia
- Clinical Research Atlanta - Stockbridge
Illinois
- Optimal Research - Peoria
Louisiana
- Alliance for Multispecialty Research, LLC - New Orleans
Michigan
- Headlands Research - Detroit - Southfield
New York
- Rochester Clinical Research, LLC - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 558 participants |
| Start Date | 2023-12-20 |
| Est. Completion | 2026-05-23 |
| Phase | Phase 1 |
What the registry record for NCT06182124 still lists
NCT06182124 is an interventional study that assigns participants to a tested intervention. The registered 558 participants enrollment target is mid-sized for trials with a published cap, above the 401-participant average among 3 other Pneumococcal Disease trials with a reported enrollment target (39% higher).
The record links to 1 condition, with Pneumococcal Disease appearing as the primary indexed condition, and to 5 interventions - of which 20-valent pneumococcal conjugate vaccine (20vPnC) is the first listed.
NCT06182124 lists 18 locations in 10 states (Texas, Florida, Tennessee).
Frequently Asked Questions
What is clinical trial NCT06182124 about?
NCT06182124 is a clinical study titled "A Study to Learn About the Safety and Immune Response of a New Pneumococcal Vaccine in Adults". The purpose of this study is to learn about the safety and immune effects of a pneumococcal vaccine in adults. This vaccine can possibly provide protection against further pneumococcal disease. This study will happen in 4 stages: Stage 1 is seeking participants who are between 18 years to 49 years ...
What is the current status of trial NCT06182124?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 558 participants. The study started on 2023-12-20. Estimated completion is 2026-05-23.
What conditions does trial NCT06182124 study?
This clinical trial studies the following conditions: Pneumococcal Disease.
What interventions are being tested in trial NCT06182124?
The interventions under investigation include: 20-valent pneumococcal conjugate vaccine (20vPnC) (BIOLOGICAL), Multivalent Pneumococcal Vaccine - Formulation 1 (BIOLOGICAL), Multivalent Pneumococcal Vaccine - Formulation 2 (BIOLOGICAL), Licensed pneumococcal comparator vaccine (BIOLOGICAL), Multivalent Pneumococcal Vaccine - Formulation 3 (BIOLOGICAL).
Who is sponsoring clinical trial NCT06182124?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06182124 being conducted?
This trial has 18 study locations across Florida, Georgia, Illinois, Louisiana, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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