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NCT00943488 · ClinicalTrials.gov registry record · Phase 2
CSL H1N1 Influenza Vaccine Administered at Two Dose Levels in Adult and Elderly Populations
A Phase 2 study of Influenza, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 408
- Enrollment target
- 4
- Study locations
NCT00943488 is a Phase 2 study of Influenza that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 408 participants, below the 36,801-participant average among 156 other Influenza trials with a reported enrollment target (99% lower). The trial reports 4 study locations across 3 states.
The verdict
NCT00943488, a Phase 2 study of Influenza, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 408 participants
- Enrollment target
- 4
- Study locations
Study Summary
The purpose of this study is to assess the safety and immune response (body's defense against disease) to an experimental H1N1 influenza vaccine in healthy adult and elderly populations. The study will enroll up to 450 healthy adults ages 18 and older with no history of H1N1 infection or vaccination. Two hundred individuals will be 18-64 years old, and the other 200 will be greater than or equal to 65 years of age. Participants will be randomly assigned to 1 of 2 possible vaccine groups: group 1 will receive 15 micrograms (mcg) of H1N1 vaccine; group 2 will receive 30 mcg of H1N1 vaccine. Both groups will receive vaccine injections on days 0 and 21 in the arm muscle. Study procedures include: medical history, physical exam, maintaining a memory aid, and blood sample collection. Participants will be involved in study related procedures for approximately 7 months.
Conditions Studied
Interventions
- BIOLOGICAL Inactivated H1N1 Vaccine
Study Locations (4)
Washington
- Group Health Cooperative - Seattle
- University of Washington - Seattle
Iowa
- University of Iowa - Iowa City
Ohio
- Cincinnati Children's Hospital Medical Center - Infectious Diseases - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 408 participants |
| Start Date | 2009-08 |
| Est. Completion | 2010-03 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00943488
The ClinicalTrials.gov registry entry for NCT00943488 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 408 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 36,801-participant average among 156 other Influenza trials with a reported enrollment target (99% lower). 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 1 condition, with Influenza appearing as the primary indexed condition, and to 1 intervention - of which Inactivated H1N1 Vaccine is the first listed.
NCT00943488 reports 4 study locations spanning 3 distinct geographic areas - top geographies include Washington, Iowa, Ohio.
Frequently Asked Questions
What is clinical trial NCT00943488 about?
NCT00943488 is a clinical study titled "CSL H1N1 Influenza Vaccine Administered at Two Dose Levels in Adult and Elderly Populations". The purpose of this study is to assess the safety and immune response (body's defense against disease) to an experimental H1N1 influenza vaccine in healthy adult and elderly populations. The study will enroll up to 450 healthy adults ages 18 and older with no history of H1N1 infection or vaccination...
What is the current status of trial NCT00943488?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 408 participants. The study started on 2009-08. Estimated completion is 2010-03.
What conditions does trial NCT00943488 study?
This clinical trial studies the following conditions: Influenza.
What interventions are being tested in trial NCT00943488?
The interventions under investigation include: Inactivated H1N1 Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT00943488?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00943488 being conducted?
This trial has 4 study locations across Iowa, Ohio, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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