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NCT00153543 · ClinicalTrials.gov registry record · Phase 1
Immunogenicity and Reactogenicity of Pneumococcal Polysaccharide and Conjugate Vaccines in Native Elders
A Phase 1 study, sponsored by Centers for Disease Control and Prevention.
- Completed
- Registry status
- Phase 1
- Development phase
- 86
- Enrollment target
NCT00153543: Completed Phase 1 study, sponsored by Centers for Disease Control and Prevention.
NCT00153543 is a Phase 1 study that has completed, run by Centers for Disease Control and Prevention. The registered enrollment target is 86 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (43% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00153543, a Phase 1 study, has completed, sponsored by Centers for Disease Control and Prevention.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 86 participants
- Enrollment target
Study Summary
To test the hypothesis that immune responses to 23-valent pneumococcal polysaccharide vaccine (PPV-23) could be improved in Alaska Native elders by immune priming with 7-valent pneumococcal conjugate vaccine (PCV-7), we assessed post-vaccination immune responses among Natives aged 55 years and older who were randomized into three arms: (1) one dose of PPV-23 according to current state and ACIP recommendations; (2) one dose of PCV-7 followed two months later with a dose of PPV-23; and (3) one dose of PCV-7 followed six months later with a dose of PPV-23.
Primary Outcome
antibody titers to 5 pneumococcal serotypes
Interventions
- BIOLOGICAL PCV7 + PPV23, 2 months
- BIOLOGICAL PCV7 + PPV23, 6 months
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 86 participants |
| Start Date | 2002-05 |
| Est. Completion | 2003-06 |
| Phase | Phase 1 |
What the finished NCT00153543 record still lists
NCT00153543 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 86 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (43% higher).
The record links to 0 conditions, and to 2 interventions - of which PCV7 + PPV23, 2 months is the first listed.
NCT00153543 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00153543 about?
NCT00153543 is a clinical study titled "Immunogenicity and Reactogenicity of Pneumococcal Polysaccharide and Conjugate Vaccines in Native Elders". To test the hypothesis that immune responses to 23-valent pneumococcal polysaccharide vaccine (PPV-23) could be improved in Alaska Native elders by immune priming with 7-valent pneumococcal conjugate vaccine (PCV-7), we assessed post-vaccination immune responses among Natives aged 55 years and older...
What is the current status of trial NCT00153543?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 86 participants. The study started on 2002-05. Estimated completion is 2003-06.
What interventions are being tested in trial NCT00153543?
The interventions under investigation include: PCV7 + PPV23, 2 months (BIOLOGICAL), PCV7 + PPV23, 6 months (BIOLOGICAL).
Who is sponsoring clinical trial NCT00153543?
This trial is sponsored by Centers for Disease Control and Prevention, which has 139 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00153543's enrollment target sits among peer trials
86 652nd of 2000 higher than 1,345 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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