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NCT01205581 · ClinicalTrials.gov registry record · Phase 2
Immunogenicity of Fluzone HD,A High Dose Influenza Vaccine, In Children With Cancer or HIV
A Phase 2 study, sponsored by St. Jude Children's Research Hospital.
- Completed
- Registry status
- Phase 2
- Development phase
- 85
- Enrollment target
NCT01205581: Completed Phase 2 study, sponsored by St. Jude Children's Research Hospital.
NCT01205581 is a Phase 2 study that has completed, run by St. Jude Children's Research Hospital. The registered enrollment target is 85 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (36% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01205581, a Phase 2 study, has completed, sponsored by St. Jude Children's Research Hospital.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 85 participants
- Enrollment target
Study Summary
This is an open label-study of Fluzone HD, a high-dose form of trivalent, inactivated influenza vaccine (TIV), vs. Fluzone, a standard-dose form of TIV. Subjects with cancer or HIV will be vaccinated twice with one of the two vaccines and evaluated for development of immune responses.
Primary Outcome
The immune response of Fluzone HD to Fluzone was determined using the hemagglutination-inhibition (HAI) assay to each of the 3 antigens contained in the vaccine: H1, H3 and B. Seroconversion was defined as a post-vaccine HAI titer ≥40 if baseline was \<10, or a 4-fold rise in HAI titer if the baseline ≥10.
Interventions
- BIOLOGICAL Fluzone High Dose Vaccine
- BIOLOGICAL Fluzone Standard Dose Vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 85 participants |
| Start Date | 2010-09 |
| Est. Completion | 2013-08 |
| Phase | Phase 2 |
What the finished NCT01205581 record still lists
NCT01205581 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 85 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (36% lower).
The record links to 0 conditions, and to 2 interventions - of which Fluzone High Dose Vaccine is the first listed.
NCT01205581 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01205581 about?
NCT01205581 is a clinical study titled "Immunogenicity of Fluzone HD,A High Dose Influenza Vaccine, In Children With Cancer or HIV". This is an open label-study of Fluzone HD, a high-dose form of trivalent, inactivated influenza vaccine (TIV), vs. Fluzone, a standard-dose form of TIV. Subjects with cancer or HIV will be vaccinated twice with one of the two vaccines and evaluated for development of immune responses.
What is the current status of trial NCT01205581?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 85 participants. The study started on 2010-09. Estimated completion is 2013-08.
What interventions are being tested in trial NCT01205581?
The interventions under investigation include: Fluzone High Dose Vaccine (BIOLOGICAL), Fluzone Standard Dose Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT01205581?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01205581's enrollment target sits among peer trials
85 820th of 2000 higher than 1,179 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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