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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 is a Phase 3 study that has completed, run by Pfizer. The registered enrollment target is 2,141 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00427895
The ClinicalTrials.gov registry entry for NCT00427895 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 2,141 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which 13-valent pneumococcal conjugate vaccine (13vPnC) is the first listed.
NCT00427895 reports 0 study locations.
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.
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