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NCT00133549 · ClinicalTrials.gov registry record · Phase 2
9-valent CRM 197 Pneumococcal
A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 180
- Enrollment target
NCT00133549: Completed Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00133549 is a Phase 2 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 180 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (35% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00133549, a Phase 2 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 180 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety and immune response of a conjugated pneumococcal vaccine compared to a licensed 23-valent polysaccharide pneumococcal vaccine in elderly adults. Study participants will include 180 adults, 65 years of age or greater. Participants will be randomly assigned to 1 of 3 possible groups. Subjects will maintain a study diary to record side effects and oral temperatures for 7 days following each vaccination. Blood samples will be collected before and 1 month following each dose of vaccine or placebo. Participants will be involved in study related procedures for up to 268 days.
Interventions
- DRUG Placebo
- BIOLOGICAL PNU-IMUNE®23
- BIOLOGICAL Nine-valent pneumococcal conjugate (PNCRM9)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 180 participants |
| Start Date | 2000-11 |
| Est. Completion | 2002-12 |
| Phase | Phase 2 |
What the finished NCT00133549 record still lists
NCT00133549 is an interventional study that assigns participants to a tested intervention. The registered 180 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (35% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00133549 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00133549 about?
NCT00133549 is a clinical study titled "9-valent CRM 197 Pneumococcal". The purpose of this study is to evaluate the safety and immune response of a conjugated pneumococcal vaccine compared to a licensed 23-valent polysaccharide pneumococcal vaccine in elderly adults. Study participants will include 180 adults, 65 years of age or greater. Participants will be randomly a...
What is the current status of trial NCT00133549?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 180 participants. The study started on 2000-11. Estimated completion is 2002-12.
What interventions are being tested in trial NCT00133549?
The interventions under investigation include: Placebo (DRUG), PNU-IMUNE®23 (BIOLOGICAL), Nine-valent pneumococcal conjugate (PNCRM9) (BIOLOGICAL).
Who is sponsoring clinical trial NCT00133549?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00133549's enrollment target sits among peer trials
180 365th of 2000 higher than 1,610 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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