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NCT01258595 · ClinicalTrials.gov registry record · Phase 2
A Study of High-Dose Trivalent Inactivated Influenza Vaccine in Adults 50 to 64 Years of Age
A Phase 2 study, sponsored by Sanofi Pasteur, a Sanofi Company.
- Completed
- Registry status
- Phase 2
- Development phase
- 300
- Enrollment target
NCT01258595: Completed Phase 2 study, sponsored by Sanofi Pasteur, a Sanofi Company.
NCT01258595 is a Phase 2 study that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 300 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (126% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01258595, a Phase 2 study, has completed, sponsored by Sanofi Pasteur, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 300 participants
- Enrollment target
Study Summary
The aim of the study is to generate data on key parameters associated with assessment of influenza vaccines in individuals 50-64 years of age Primary Objective: * To describe the immunogenicity of High-Dose Trivalent Inactivated Influenza Vaccine (TIV) compared to TIV. * To describe the safety profile of High-Dose Trivalent Inactivated Influenza Vaccine, as assessed by solicited adverse reactions collected for 7 days post-vaccination, and unsolicited adverse events (including Serious Adverse Events and Adverse Events of Special Interests) collected between Visit 1 and Visit 2
Primary Outcome
Serum antibody titers to vaccine antigens were assessed by means of the hemagglutination inhibition (HAI) assay method.
Interventions
- BIOLOGICAL Trivalent Inactivated Influenza Vaccine
- BIOLOGICAL High-Dose Trivalent Inactivated Influenza Vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2010-11 |
| Est. Completion | 2011-04 |
| Phase | Phase 2 |
What the finished NCT01258595 record still lists
NCT01258595 is an interventional study that assigns participants to a tested intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (126% higher).
The record links to 0 conditions, and to 2 interventions - of which Trivalent Inactivated Influenza Vaccine is the first listed.
NCT01258595 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01258595 about?
NCT01258595 is a clinical study titled "A Study of High-Dose Trivalent Inactivated Influenza Vaccine in Adults 50 to 64 Years of Age". The aim of the study is to generate data on key parameters associated with assessment of influenza vaccines in individuals 50-64 years of age Primary Objective: * To describe the immunogenicity of High-Dose Trivalent Inactivated Influenza Vaccine (TIV) compared to TIV. * To describe the safety pro...
What is the current status of trial NCT01258595?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 300 participants. The study started on 2010-11. Estimated completion is 2011-04.
What interventions are being tested in trial NCT01258595?
The interventions under investigation include: Trivalent Inactivated Influenza Vaccine (BIOLOGICAL), High-Dose Trivalent Inactivated Influenza Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT01258595?
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 NCT01258595's enrollment target sits among peer trials
300 167th of 2000 higher than 1,813 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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