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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 is a Phase 2 study that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 300 participants.
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01258595
The ClinicalTrials.gov registry entry for NCT01258595 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi Pasteur, a Sanofi Company, which has 153 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Trivalent Inactivated Influenza Vaccine is the first listed.
NCT01258595 reports 0 study locations.
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.
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