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NCT01086566 · ClinicalTrials.gov registry record · Phase 1
Cellular and Humoral Immune Response to Primary and Secondary Immunization With Subvirion H5N1 Vaccines
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 95
- Enrollment target
NCT01086566 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 95 participants.
The verdict
NCT01086566, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 95 participants
- Enrollment target
Study Summary
The purpose of the study is to evaluate safety and compare how the body reacts to 2 different strengths of the Clade (specific type of H5N1 virus) 2 H5N1 flu vaccine when given as a single vaccination with a high dose (90 mcg) or low dose (15 mcg) to volunteers who have received at least 2 doses of the Clade 1 H5N1 vaccine, in a previous National Institute of Health study or who have never received a H5N1 vaccine (naïve). Previously vaccinated subjects (in studies 04-0063, 05-0090, 05-0127) will receive either 15 or 90 mcg of H5N1 vaccine. Multiply boosted volunteers who participated study 05-0043 and received Clade 1 and 3 vaccines, will receive the same dose (15mcg). Vaccine naïve subjects will receive 2 doses of vaccine (15 or 90 mcg) separated by 28 days. Blood samples will be collected. 115 volunteers age 18-64 may participate in study related procedures for approximately 7 months.
Interventions
- BIOLOGICAL Influenza Virus Vaccine, Monovalent A/H5N1 A/Indonesia/05/2005
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 95 participants |
| Start Date | 2010-10 |
| Est. Completion | 2012-02 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01086566
The ClinicalTrials.gov registry entry for NCT01086566 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 95 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 Influenza Virus Vaccine, Monovalent A/H5N1 A/Indonesia/05/2005 is the first listed.
NCT01086566 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01086566 about?
NCT01086566 is a clinical study titled "Cellular and Humoral Immune Response to Primary and Secondary Immunization With Subvirion H5N1 Vaccines". The purpose of the study is to evaluate safety and compare how the body reacts to 2 different strengths of the Clade (specific type of H5N1 virus) 2 H5N1 flu vaccine when given as a single vaccination with a high dose (90 mcg) or low dose (15 mcg) to volunteers who have received at least 2 doses of ...
What is the current status of trial NCT01086566?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 95 participants. The study started on 2010-10. Estimated completion is 2012-02.
What interventions are being tested in trial NCT01086566?
The interventions under investigation include: Influenza Virus Vaccine, Monovalent A/H5N1 A/Indonesia/05/2005 (BIOLOGICAL).
Who is sponsoring clinical trial NCT01086566?
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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