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NCT00574548 · ClinicalTrials.gov registry record · Phase 3
Study Evaluating the Safety, Tolerability and Immunogenicity of 13vPnC as a 2-Dose Regimen or With 23vPS
A Phase 3 study, sponsored by Wyeth is now a wholly owned subsidiary of Pfizer.
- Completed
- Registry status
- Phase 3
- Development phase
- 720
- Enrollment target
NCT00574548: Completed Phase 3 study, sponsored by Wyeth is now a wholly owned subsidiary of Pfizer.
NCT00574548 is a Phase 3 study that has completed, run by Wyeth is now a wholly owned subsidiary of Pfizer. The registered enrollment target is 720 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00574548, a Phase 3 study, has completed, sponsored by Wyeth is now a wholly owned subsidiary of Pfizer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 720 participants
- Enrollment target
Study Summary
The objective of this study is to compare the safety, tolerability and immunologic response to a dose of 23vPS or 13vPnC given one year after either 13vPnC or 23vPS in subjects that have never received a previous dose of 23vPS.
Primary Outcome
Antibody geometric mean titers as measured by opsonophagocytic assays (OPA) for 12 common pneumococcal 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.
Interventions
- BIOLOGICAL 13 valent Pneumococcal Conjugate Vaccine
- BIOLOGICAL 23-valent Pneumococcal Polysaccharide Vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 720 participants |
| Start Date | 2007-11 |
| Est. Completion | 2010-02 |
| Phase | Phase 3 |
What the finished NCT00574548 record still lists
NCT00574548 is an interventional study that assigns participants to a tested intervention. The registered 720 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which 13 valent Pneumococcal Conjugate Vaccine is the first listed.
NCT00574548 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00574548 about?
NCT00574548 is a clinical study titled "Study Evaluating the Safety, Tolerability and Immunogenicity of 13vPnC as a 2-Dose Regimen or With 23vPS". The objective of this study is to compare the safety, tolerability and immunologic response to a dose of 23vPS or 13vPnC given one year after either 13vPnC or 23vPS in subjects that have never received a previous dose of 23vPS.
What is the current status of trial NCT00574548?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 720 participants. The study started on 2007-11. Estimated completion is 2010-02.
What interventions are being tested in trial NCT00574548?
The interventions under investigation include: 13 valent Pneumococcal Conjugate Vaccine (BIOLOGICAL), 23-valent Pneumococcal Polysaccharide Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT00574548?
This trial is sponsored by Wyeth is now a wholly owned subsidiary of Pfizer, which has 167 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00574548's enrollment target sits among peer trials
720 494th of 2000 higher than 1,503 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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