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NCT00427895 · ClinicalTrials.gov registry record · Phase 3
Study Comparing a 13-valent Pneumococcal Conjugate Vaccine With 23-valent Pneumococcal Polysaccharide Vaccine in Adults
A Phase 3 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 3
- Development phase
- 2,141
- Enrollment target
NCT00427895: Completed Phase 3 study, sponsored by Pfizer.
NCT00427895 is a Phase 3 study that has completed, run by Pfizer. The registered enrollment target is 2,141 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (177% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00427895, a Phase 3 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 2,141 participants
- Enrollment target
Study Summary
This study will assess the safety, tolerability and immune response of 13-valent pneumococcal conjugate vaccine (13vPnC) compared with 23-valent Pneumococcal Polysaccharide Vaccine (23vPS). Although the study started with only 1 population, amendments to the original protocol will now reflect three participant populations. Three age cohorts will be enrolled. The first cohort (age 60-64) will be blinded. Cohort 2 (age 50-59) and cohort 3 (age 18-49) are open label. Subjects in cohorts 1 and 2 will receive 2 vaccinations 3-4 years apart. Subjects in cohort 3 will receive 1 vaccination. All participants should be naïve of 23vPS. Comparisons of immune responses from the different cohorts will be done.
Primary Outcome
Serotype-specific OPA GMTs for the 13 pneumococcal common serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of all the participants using microcolony OPA (mcOPA) assay. CIs for GMT 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 (13vPnC)
- BIOLOGICAL 23-valent Pneumococcal Polysaccharide Vaccine (23vPS)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,141 participants |
| Start Date | 2007-02-27 |
| Est. Completion | 2011-08-01 |
| Phase | Phase 3 |
What the finished NCT00427895 record still lists
NCT00427895 is an interventional study that assigns participants to a tested intervention. Its 2,141 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (177% higher).
The record links to 0 conditions, and to 2 interventions - of which 13-valent pneumococcal conjugate vaccine (13vPnC) is the first listed.
NCT00427895 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00427895 about?
NCT00427895 is a clinical study titled "Study Comparing a 13-valent Pneumococcal Conjugate Vaccine With 23-valent Pneumococcal Polysaccharide Vaccine in Adults". This study will assess the safety, tolerability and immune response of 13-valent pneumococcal conjugate vaccine (13vPnC) compared with 23-valent Pneumococcal Polysaccharide Vaccine (23vPS). Although the study started with only 1 population, amendments to the original protocol will now reflect three ...
What is the current status of trial NCT00427895?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,141 participants. The study started on 2007-02-27. Estimated completion is 2011-08-01.
What interventions are being tested in trial NCT00427895?
The interventions under investigation include: 13-valent pneumococcal conjugate vaccine (13vPnC) (BIOLOGICAL), 23-valent Pneumococcal Polysaccharide Vaccine (23vPS) (BIOLOGICAL).
Who is sponsoring clinical trial NCT00427895?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00427895's enrollment target sits among peer trials
2,141 96th of 2000 higher than 1,905 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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