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NCT05297578 · ClinicalTrials.gov registry record · Phase 2
Safety, Tolerability, and Immunogenicity Study of a 24-Valent Pneumococcal Conjugate Vaccine (VAX-24) in Older Adults
A Phase 2 study of Pneumococcal Vaccines, sponsored by Vaxcyte.
- Completed
- Registry status
- Phase 2
- Development phase
- 207
- Enrollment target
- 20
- Study locations
NCT05297578: Completed Phase 2 study of Pneumococcal Vaccines, sponsored by Vaxcyte.
NCT05297578 is a Phase 2 study of Pneumococcal Vaccines that has completed, run by Vaxcyte. The registered enrollment target is 207 participants, below the 1,545-participant average among 5 other Pneumococcal Vaccines trials with a reported enrollment target (87% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05297578, a Phase 2 study of Pneumococcal Vaccines, has completed, sponsored by Vaxcyte.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 207 participants
- Enrollment target
- 20
- Study locations
Study Summary
The objective of the study is to evaluate the safety and tolerability of a single injection of VAX-24 at 3 dose levels compared to Prevnar 20™ (PCV20) in adults 65 years of age and older.
Primary Outcome
Solicited local reactions included redness/erythema, swelling/induration, and pain at injection site
Conditions Studied
Interventions
- BIOLOGICAL Pneumococcal 20-valent Conjugate Vaccine
- BIOLOGICAL 24-Valent Pneumococcal Conjugate Vaccine
Study Locations (20)
Florida
- Accel Research Sites - DeLand Clinical Research Unit - DeLand
- CenExel RCA - Hollywood
- Precision Clinical Research - Sunrise
Georgia
- Meridian Clinical Research - Savannah
- Pivotal Research Solutions - Stonecrest
Kansas
- AMR Newton, formerly Heartland Research Associates - Newton
- AMR Wichita West - Wichita
South Carolina
- Accellacare of Charleston - Mt. Pleasant
- Coastal Carolina Research - North Charleston
Utah
- CenExel JBR Clinical Research - Salt Lake City
- Velocity Clinical Research, Salt Lake City - West Jordan
Alabama
- Accel Research Sites-Birmingham Clinical Research Unit - Birmingham
Illinois
- Healthcare Research Network II, LLC - Flossmoor
Louisiana
- AMR New Orleans - New Orleans
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 207 participants |
| Start Date | 2022-06-15 |
| Est. Completion | 2023-02-15 |
| Phase | Phase 2 |
What the finished NCT05297578 record still lists
NCT05297578 is an interventional study that assigns participants to a tested intervention. The registered 207 participants enrollment target is mid-sized for trials with a published cap, below the 1,545-participant average among 5 other Pneumococcal Vaccines trials with a reported enrollment target (87% lower).
The record links to 1 condition, with Pneumococcal Vaccines appearing as the primary indexed condition, and to 2 interventions - of which Pneumococcal 20-valent Conjugate Vaccine is the first listed.
NCT05297578 names 20 study sites across 14 states, led by Florida, Georgia, Kansas.
Frequently Asked Questions
What is clinical trial NCT05297578 about?
NCT05297578 is a clinical study titled "Safety, Tolerability, and Immunogenicity Study of a 24-Valent Pneumococcal Conjugate Vaccine (VAX-24) in Older Adults". The objective of the study is to evaluate the safety and tolerability of a single injection of VAX-24 at 3 dose levels compared to Prevnar 20™ (PCV20) in adults 65 years of age and older.
What is the current status of trial NCT05297578?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 207 participants. The study started on 2022-06-15. Estimated completion is 2023-02-15.
What conditions does trial NCT05297578 study?
This clinical trial studies the following conditions: Pneumococcal Vaccines.
What interventions are being tested in trial NCT05297578?
The interventions under investigation include: Pneumococcal 20-valent Conjugate Vaccine (BIOLOGICAL), 24-Valent Pneumococcal Conjugate Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT05297578?
This trial is sponsored by Vaxcyte, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05297578 being conducted?
This trial has 20 study locations across Alabama, Florida, Georgia, Illinois, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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