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NCT00231907 · ClinicalTrials.gov registry record · Phase 1
A Phase I Safety and Immunogenicity Study of Mix and Match of Licensed Flu Vaccine and Flumist
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 56
- Enrollment target
NCT00231907 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 56 participants.
The verdict
NCT00231907, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 56 participants
- Enrollment target
Study Summary
The purpose of this research is to compare the safety and ability to stimulate antibodies (part of the bodies proteins that fight infections) of two influenza (flu) vaccines given to children 12 to 35 months old. The two flu vaccines being compared are: trivalent inactivated influenza virus vaccine (TIV), a killed virus vaccine given as a shot licensed for use in children 6 months of age or older and live attenuated influenza vaccine (LAIV), a live (but weakened) virus vaccine licensed for children 5 years old and older given as a nose spray. The strains of the viruses have been weakened so that they do not cause typical influenza illness, but may allow the body to develop protection against the flu. LAIV vaccine is not licensed for children less than five years of age, therefore its use in this study is investigational. Participation is approximately 7 months in duration.
Interventions
- BIOLOGICAL Fluzone
- BIOLOGICAL FluMist
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2005-09 |
| Est. Completion | 2007-03 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00231907
The ClinicalTrials.gov registry entry for NCT00231907 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 56 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 2 interventions - of which Fluzone is the first listed.
NCT00231907 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00231907 about?
NCT00231907 is a clinical study titled "A Phase I Safety and Immunogenicity Study of Mix and Match of Licensed Flu Vaccine and Flumist". The purpose of this research is to compare the safety and ability to stimulate antibodies (part of the bodies proteins that fight infections) of two influenza (flu) vaccines given to children 12 to 35 months old. The two flu vaccines being compared are: trivalent inactivated influenza virus vaccine ...
What is the current status of trial NCT00231907?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 56 participants. The study started on 2005-09. Estimated completion is 2007-03.
What interventions are being tested in trial NCT00231907?
The interventions under investigation include: Fluzone (BIOLOGICAL), FluMist (BIOLOGICAL).
Who is sponsoring clinical trial NCT00231907?
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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