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NCT00963235 · ClinicalTrials.gov registry record · Phase 3
Safety & Immunogenicity of 13vPnC in HIV-Infected Subjects Aged 18 or Older Who Were Previously Immunized With 23vPS
A Phase 3 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 3
- Development phase
- 331
- Enrollment target
NCT00963235: Completed Phase 3 study, sponsored by Pfizer.
NCT00963235 is a Phase 3 study that has completed, run by Pfizer. The registered enrollment target is 331 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (57% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00963235, a Phase 3 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 331 participants
- Enrollment target
Study Summary
The study will evaluate the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate vaccine (13vPnC) in HIV-infected subjects 18 years of age or older who have been previously immunized with at least one dose of 23-valent pneumococcal polysaccharide vaccine (23vPS). All subjects will receive 3 doses of 13vPnC, with each study vaccine dose given approximately 6 months apart.
Primary Outcome
Geometric mean fold rises (GMFRs) for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month post-dose 2 to 1 month post-dose 3 were computed using the logarithmically transformed assay results. Confidence interval (CI) for the GMFRs were back transformations of a CI based on the Student t distribution for the logarithmically transformed assay results.
Interventions
- PROCEDURE Blood draw
- BIOLOGICAL 13-valent pneumococcal conjugate vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 331 participants |
| Start Date | 2009-11 |
| Est. Completion | 2012-05 |
| Phase | Phase 3 |
What the finished NCT00963235 record still lists
NCT00963235 is an interventional study that assigns participants to a tested intervention. The registered 331 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (57% lower).
The record links to 0 conditions, and to 2 interventions - of which Blood draw is the first listed.
NCT00963235 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00963235 about?
NCT00963235 is a clinical study titled "Safety & Immunogenicity of 13vPnC in HIV-Infected Subjects Aged 18 or Older Who Were Previously Immunized With 23vPS". The study will evaluate the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate vaccine (13vPnC) in HIV-infected subjects 18 years of age or older who have been previously immunized with at least one dose of 23-valent pneumococcal polysaccharide vaccine (23vPS). All subject...
What is the current status of trial NCT00963235?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 331 participants. The study started on 2009-11. Estimated completion is 2012-05.
What interventions are being tested in trial NCT00963235?
The interventions under investigation include: Blood draw (PROCEDURE), 13-valent pneumococcal conjugate vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT00963235?
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 NCT00963235's enrollment target sits among peer trials
331 1066th of 2000 higher than 935 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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