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NCT01011049 · ClinicalTrials.gov registry record · Phase 2
Study of Influenza Vaccine Revaccination in Healthy Adults Previously Vaccinated With Fluzone ID or Fluzone IM
A Phase 2 study, sponsored by Sanofi Pasteur, a Sanofi Company.
- Completed
- Registry status
- Phase 2
- Development phase
- 1,250
- Enrollment target
NCT01011049: Completed Phase 2 study, sponsored by Sanofi Pasteur, a Sanofi Company.
NCT01011049 is a Phase 2 study that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 1,250 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (840% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01011049, a Phase 2 study, has completed, sponsored by Sanofi Pasteur, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 1,250 participants
- Enrollment target
Study Summary
The purpose of this study is to generate additional data on the immunogenicity and safety of revaccination with Fluzone Intradermal (ID) or Fluzone Intramuscular (IM) vaccine. Primary Objective: * To evaluate and describe the safety profile of revaccination with Fluzone ID for all participants. Secondary Objective: * To describe immunogenicity following revaccination with Fluzone ID or Fluzone IM.
Primary Outcome
Solicited injection site reactions: Erythema (redness), Swelling, Induration, Pain, Pruritus, Ecchymosis. Solicited systemic reactions: Headache, Myalgia, Malaise, Shivering, Fever (temperature).
Interventions
- BIOLOGICAL Influenza Virus Vaccine USP Trivalent Types A and B
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,250 participants |
| Start Date | 2009-09 |
| Est. Completion | 2010-10 |
| Phase | Phase 2 |
What the finished NCT01011049 record still lists
NCT01011049 is an interventional study that assigns participants to a tested intervention. Its 1,250 participants enrollment target places it among the larger protocols in the corpus, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (840% higher).
The record links to 0 conditions, and to 1 intervention - of which Influenza Virus Vaccine USP Trivalent Types A and B is the first listed.
NCT01011049 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01011049 about?
NCT01011049 is a clinical study titled "Study of Influenza Vaccine Revaccination in Healthy Adults Previously Vaccinated With Fluzone ID or Fluzone IM". The purpose of this study is to generate additional data on the immunogenicity and safety of revaccination with Fluzone Intradermal (ID) or Fluzone Intramuscular (IM) vaccine. Primary Objective: * To evaluate and describe the safety profile of revaccination with Fluzone ID for all participants. S...
What is the current status of trial NCT01011049?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 1,250 participants. The study started on 2009-09. Estimated completion is 2010-10.
What interventions are being tested in trial NCT01011049?
The interventions under investigation include: Influenza Virus Vaccine USP Trivalent Types A and B (BIOLOGICAL).
Who is sponsoring clinical trial NCT01011049?
This trial is sponsored by Sanofi Pasteur, a Sanofi Company, which has 153 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01011049's enrollment target sits among peer trials
1,250 16th of 2000 higher than 1,985 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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