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NCT00115531 · ClinicalTrials.gov registry record · Phase 2
Eldery High Dose TIV 2005
A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 414
- Enrollment target
NCT00115531 is a Phase 2 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 414 participants.
The verdict
NCT00115531, a Phase 2 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 414 participants
- Enrollment target
Study Summary
The purpose of this study is to compare a new higher-dose influenza virus vaccine to the standard dose vaccine in elderly adults who can walk. Current influenza vaccines protect elderly against viral influenza but not as well as desired. It is expected that the higher doses vaccine can be given with little reaction, but this needs to be tested. Up to 410 people ages 65 years and older will be recruited from the community and from existing volunteer populations. Participants will receive either the high or standard dose injected in the muscle, remain in the clinic for 20 minutes afterward, and maintain a daily memory aid for 7 days. The memory aid will be reviewed by telephone 8-12 days after the injection and return to the clinic or contacted by telephone 6 months after the injection.
Interventions
- BIOLOGICAL Trivalent inactivated influenza vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 414 participants |
| Start Date | 2005-04 |
| Est. Completion | 2005-11 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00115531
The ClinicalTrials.gov registry entry for NCT00115531 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 414 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 1 intervention - of which Trivalent inactivated influenza vaccine is the first listed.
NCT00115531 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00115531 about?
NCT00115531 is a clinical study titled "Eldery High Dose TIV 2005". The purpose of this study is to compare a new higher-dose influenza virus vaccine to the standard dose vaccine in elderly adults who can walk. Current influenza vaccines protect elderly against viral influenza but not as well as desired. It is expected that the higher doses vaccine can be given with...
What is the current status of trial NCT00115531?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 414 participants. The study started on 2005-04. Estimated completion is 2005-11.
What interventions are being tested in trial NCT00115531?
The interventions under investigation include: Trivalent inactivated influenza vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT00115531?
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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