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NCT00231920 · ClinicalTrials.gov registry record · Phase 1
Inactivated Influenza Vaccine in Infants 10-22 Weeks of Age
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 23
- Enrollment target
NCT00231920: Completed Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00231920 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 23 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00231920, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 23 participants
- Enrollment target
Study Summary
This study proposes to enroll 50 young infants, ages 10 to 22 weeks. Each of the fifty infants will receive two 0.25mL doses of preservative-free Fluzone®, given a minimum of 28 days apart but no more than 42 days apart. Preservative-free Fluzone® will not be administered at the same time as other routine vaccines. Approximately 2-3mLs of blood sample will be obtained prior to the first vaccination, approximately 4 weeks after the second vaccination and 6 months after the second vaccination for the measurement of immune response. The primary purpose of this study is twofold: 1.) To determine the safety of administering two doses of preservative-free Fluzone® to young infants and 2.) To determine the capability of inducing an immune response of administering two doses of preservative-free Fluzone® to young infants.
Interventions
- BIOLOGICAL Fluzone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2004-10 |
| Est. Completion | 2006-10 |
| Phase | Phase 1 |
What the finished NCT00231920 record still lists
NCT00231920 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 1 intervention - of which Fluzone is the first listed.
NCT00231920 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00231920 about?
NCT00231920 is a clinical study titled "Inactivated Influenza Vaccine in Infants 10-22 Weeks of Age". This study proposes to enroll 50 young infants, ages 10 to 22 weeks. Each of the fifty infants will receive two 0.25mL doses of preservative-free Fluzone®, given a minimum of 28 days apart but no more than 42 days apart. Preservative-free Fluzone® will not be administered at the same time as other r...
What is the current status of trial NCT00231920?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 23 participants. The study started on 2004-10. Estimated completion is 2006-10.
What interventions are being tested in trial NCT00231920?
The interventions under investigation include: Fluzone (BIOLOGICAL).
Who is sponsoring clinical trial NCT00231920?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00231920's enrollment target sits among peer trials
23 1596th of 2000 higher than 400 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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