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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 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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00133549
The ClinicalTrials.gov registry entry for NCT00133549 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 180 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00133549 reports 0 study locations.
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.
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