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NCT00546572 · ClinicalTrials.gov registry record · Phase 3
Study Evaluating The Safety, Tolerability And Immunogenicity Of A 13-Valent Pneumococcal Conjugate Vaccine (13vPnC)
A Phase 3 study of Pneumococcal Infections, sponsored by Wyeth is now a wholly owned subsidiary of Pfizer.
- Completed
- Registry status
- Phase 3
- Development phase
- 938
- Enrollment target
- 20
- Study locations
NCT00546572: Completed Phase 3 study of Pneumococcal Infections, sponsored by Wyeth is now a wholly owned subsidiary of Pfizer.
NCT00546572 is a Phase 3 study of Pneumococcal Infections that has completed, run by Wyeth is now a wholly owned subsidiary of Pfizer. The registered enrollment target is 938 participants, above the 811-participant average among 10 other Pneumococcal Infections trials with a reported enrollment target (16% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00546572, a Phase 3 study of Pneumococcal Infections, has completed, sponsored by Wyeth is now a wholly owned subsidiary of Pfizer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 938 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study will evaluate the safety, tolerability and immunogenicity of study vaccines 13vPnC and 23vPS in older, healthy subjects who have previously received a dose of 23vPS at least 5 years ago. It will also evaluate the safety, tolerability and immunogenicity to a dose of 13vPnC 1 year after the initial dose of study vaccine.
Primary Outcome
Antibody geometric mean titers as measured by opsonophagocytic activity (OPA) assays for the 12 common serotypes (serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.
Conditions Studied
Interventions
- BIOLOGICAL 13 valent Pneumococcal Conjugate Vaccine
- BIOLOGICAL 23vPS
Study Locations (20)
Florida
- Pfizer Investigational Site - Clearwater
- Pfizer Investigational Site - Coral Gables
- Pfizer Investigational Site - Jacksonville
- Pfizer Investigational Site - Pinellas Park
- Pfizer Investigational Site - Tampa
Georgia
- Pfizer Investigational Site - Atlanta
- Pfizer Investigational Site - Atlanta
- Pfizer Investigational Site - Stockbridge
Arizona
- Pfizer Investigational Site - Mesa
- Pfizer Investigational Site - Mesa
Minnesota
- Pfizer Investigational Site - Minneapolis
- Pfizer Investigational Site - Rochester
Alabama
- Pfizer Investigational Site - Mobile
California
- Pfizer Investigational Site - Fountain Valley
Colorado
- Pfizer Investigational Site - Denver
Connecticut
- Pfizer Investigational Site - Waterbury
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 938 participants |
| Start Date | 2007-11 |
| Est. Completion | 2010-07 |
| Phase | Phase 3 |
What the finished NCT00546572 record still lists
NCT00546572 is an interventional study that assigns participants to a tested intervention. The registered 938 participants enrollment target is mid-sized for trials with a published cap, above the 811-participant average among 10 other Pneumococcal Infections trials with a reported enrollment target (16% higher).
The record links to 1 condition, with Pneumococcal Infections appearing as the primary indexed condition, and to 2 interventions - of which 13 valent Pneumococcal Conjugate Vaccine is the first listed.
NCT00546572 names 20 study sites across 12 states, led by Florida, Georgia, Arizona.
Frequently Asked Questions
What is clinical trial NCT00546572 about?
NCT00546572 is a clinical study titled "Study Evaluating The Safety, Tolerability And Immunogenicity Of A 13-Valent Pneumococcal Conjugate Vaccine (13vPnC)". This study will evaluate the safety, tolerability and immunogenicity of study vaccines 13vPnC and 23vPS in older, healthy subjects who have previously received a dose of 23vPS at least 5 years ago. It will also evaluate the safety, tolerability and immunogenicity to a dose of 13vPnC 1 year after the...
What is the current status of trial NCT00546572?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 938 participants. The study started on 2007-11. Estimated completion is 2010-07.
What conditions does trial NCT00546572 study?
This clinical trial studies the following conditions: Pneumococcal Infections.
What interventions are being tested in trial NCT00546572?
The interventions under investigation include: 13 valent Pneumococcal Conjugate Vaccine (BIOLOGICAL), 23vPS (BIOLOGICAL).
Who is sponsoring clinical trial NCT00546572?
This trial is sponsored by Wyeth is now a wholly owned subsidiary of Pfizer, which has 167 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00546572 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Pneumococcal Infections
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00546572's enrollment target sits among peer trials
938 6th of 10 higher than 5 of 10 other Pneumococcal Infections trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pneumococcal Infections trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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