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NCT00918580 · ClinicalTrials.gov registry record · Phase 3
Study Evaluating 13-valent Pneumococcal Conjugate Vaccine (13vPnC) in Children With Sickle Cell Disease
A Phase 3 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 3
- Development phase
- 158
- Enrollment target
NCT00918580: Completed Phase 3 study, sponsored by Pfizer.
NCT00918580 is a Phase 3 study that has completed, run by Pfizer. The registered enrollment target is 158 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00918580, a Phase 3 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 158 participants
- Enrollment target
Study Summary
This study is to evaluate the safety, tolerability and immunogenicity of 13-valent pneumococcal Conjugate Vaccine in children with Sickle Cell Disease who have already been vaccinated with 23-valent polysaccharide vaccine. The study will measure the amount of antibodies (the proteins that fight off germs) produced by children with Sickle Cell Disease after they have been given the 13-valent pneumococcal vaccine between 6 and less than 18 years of age. They will be given the vaccination twice, each vaccination separated by approximately 6 months.
Primary Outcome
GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month after 13vPnC Dose 1 to 1 month after 13vPnC Dose 2 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 1 month after 13vPnC Dose 1 and after 13vPnC Dos
Interventions
- BIOLOGICAL 13-valent Pneumoccocal Conjugate Vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 158 participants |
| Start Date | 2009-11 |
| Est. Completion | 2013-03 |
| Phase | Phase 3 |
What the finished NCT00918580 record still lists
NCT00918580 is an interventional study that assigns participants to a tested intervention. The registered 158 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 (80% lower).
The record links to 0 conditions, and to 1 intervention - of which 13-valent Pneumoccocal Conjugate Vaccine is the first listed.
NCT00918580 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00918580 about?
NCT00918580 is a clinical study titled "Study Evaluating 13-valent Pneumococcal Conjugate Vaccine (13vPnC) in Children With Sickle Cell Disease". This study is to evaluate the safety, tolerability and immunogenicity of 13-valent pneumococcal Conjugate Vaccine in children with Sickle Cell Disease who have already been vaccinated with 23-valent polysaccharide vaccine. The study will measure the amount of antibodies (the proteins that fight off ...
What is the current status of trial NCT00918580?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 158 participants. The study started on 2009-11. Estimated completion is 2013-03.
What interventions are being tested in trial NCT00918580?
The interventions under investigation include: 13-valent Pneumoccocal Conjugate Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT00918580?
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 NCT00918580's enrollment target sits among peer trials
158 1502nd of 2000 higher than 496 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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