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NCT00980655 · ClinicalTrials.gov registry record · Phase 3
Study to Evaluate 13 Valent Pneumococcal Conjugate Vaccine (13vPnC) Vaccine Followed by 23-valent Pneumococcal Polysaccharide Vaccine (23vPS) Vaccine in Allogeneic Hematopoietic Stem Cell Transplant Recipients
A Phase 3 study of Vaccines, Pneumococcal Conjugate Vaccine, sponsored by Pfizer.
- Completed
- Registry status
- Phase 3
- Development phase
- 251
- Enrollment target
- 20
- Study locations
NCT00980655: Completed Phase 3 study of Vaccines, Pneumococcal Conjugate Vaccine, sponsored by Pfizer.
NCT00980655 is a Phase 3 study of Vaccines, Pneumococcal Conjugate Vaccine that has completed, run by Pfizer. The registered enrollment target is 251 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (67% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00980655, a Phase 3 study of Vaccines, Pneumococcal Conjugate Vaccine, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 251 participants
- Enrollment target
- 20
- Study locations
Study Summary
People who have received an allogeneic hematopoetic stem cell transplant (HSCT) are more likely than other people to get ill from a germ called Streptococcus pneumoniae. Most people who have had a stem cell transplant are offered a vaccine called 23-valent pneumococcal polysaccharide vaccine (23vPS) to help protect against this germ. The purpose of this study is to evaluate the immune response in HSCT recipients who receive a 13 valent pneumococcal vaccine (13vPnC) followed by 23vPS.
Primary Outcome
GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from before 13vPnC Dose 1 to 1 month after 13vPnC Dose 3 were computed using the logarithmically transformed assay results. Confidence interval (CI) for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both before 13vPnC Dose 1 and after 13vPnC Dose 3 blood draw
Conditions Studied
Interventions
- BIOLOGICAL 23vPS
- BIOLOGICAL 13vPnC
Study Locations (20)
Other
- Universitair Ziekenhuis Gent - Belgium
- Algemeen Ziekenhuis St.-Jan A.V. - Bruges
- Clinical University St Luc - Brussels
- Universitaire Ziekenhuizen Leuven (UZ) Gasthuisberg - Leuven
- CHU Liege - Liège
- Fakultni nemocnice Brno/Interni hematoonkologicka klinika - Bmo
- Fakultni nemocnice v Motole - Prague
- Hôpital Jean Minjoz - Besançon
- Hopital Henri Mondor - Créteil
New York
- Steven and Alexandra Cohen Children's Medical Center of New York - New Hyde Park
- Columbia University Medical Center Research Pharmacy - New York
- Columbia University Medical Center-Presbyterian Hospital Building - New York
- Columbia University/Taub Institute Irving Center for Clinical Research - New York
- New York-Presbyterian Morgan Stanley Children's Hospital - New York
- Memorial Sloan Kettering Cancer Center - New York
Kentucky
- University of Kentucky - Lexington
Pennsylvania
- The Children's Hospital of Philadelphia - Philadelphia
Texas
- Texas Children's Hospital - Houston
Manitoba
- CancerCare Manitoba - Winnipeg
Quebec
- Hopital Maisonneuve-Rosemont - Montreal
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 251 participants |
| Start Date | 2010-01-18 |
| Est. Completion | 2013-05-16 |
| Phase | Phase 3 |
What the finished NCT00980655 record still lists
NCT00980655 is an interventional study that assigns participants to a tested intervention. The registered 251 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 (67% lower).
The record links to 1 condition, with Vaccines, Pneumococcal Conjugate Vaccine appearing as the primary indexed condition, and to 2 interventions - of which 23vPS is the first listed.
NCT00980655 names 20 study sites across 7 states, led by Other, New York, Kentucky.
Frequently Asked Questions
What is clinical trial NCT00980655 about?
NCT00980655 is a clinical study titled "Study to Evaluate 13 Valent Pneumococcal Conjugate Vaccine (13vPnC) Vaccine Followed by 23-valent Pneumococcal Polysaccharide Vaccine (23vPS) Vaccine in Allogeneic Hematopoietic Stem Cell Transplant Recipients". People who have received an allogeneic hematopoetic stem cell transplant (HSCT) are more likely than other people to get ill from a germ called Streptococcus pneumoniae. Most people who have had a stem cell transplant are offered a vaccine called 23-valent pneumococcal polysaccharide vaccine (23vPS)...
What is the current status of trial NCT00980655?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 251 participants. The study started on 2010-01-18. Estimated completion is 2013-05-16.
What conditions does trial NCT00980655 study?
This clinical trial studies the following conditions: Vaccines, Pneumococcal Conjugate Vaccine.
What interventions are being tested in trial NCT00980655?
The interventions under investigation include: 23vPS (BIOLOGICAL), 13vPnC (BIOLOGICAL).
Who is sponsoring clinical trial NCT00980655?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00980655 being conducted?
This trial has 20 study locations across Kentucky, New York, Pennsylvania, Texas, Manitoba. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00980655's enrollment target sits among peer trials
251 1249th of 2000 higher than 752 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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