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NCT01430819 · ClinicalTrials.gov registry record · Phase 4
Study of Fluzone® Influenza Virus Vaccine 2011-2012 Formulation (Intramuscular Route) Among Adults
A Phase 4 study of Influenza, sponsored by Sanofi Pasteur, a Sanofi Company.
- Completed
- Registry status
- Phase 4
- Development phase
- 300
- Enrollment target
- 6
- Study locations
NCT01430819: Completed Phase 4 study of Influenza, sponsored by Sanofi Pasteur, a Sanofi Company.
NCT01430819 is a Phase 4 study of Influenza that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 300 participants, below the 36,802-participant average among 156 other Influenza trials with a reported enrollment target (99% lower). The trial reports 6 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01430819, a Phase 4 study of Influenza, has completed, sponsored by Sanofi Pasteur, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 300 participants
- Enrollment target
- 6
- Study locations
Study Summary
The aim of the study is to evaluate the safety and immunogenicity of the 2011-2012 formulation of Fluzone and Fluzone High-Dose vaccines in participants aged 65 years and older. Objectives: * To describe the safety of Fluzone vaccine and Fluzone High-Dose vaccine among adults ≥ 65 years of age. * To describe the immunogenicity of Fluzone vaccine and Fluzone High-Dose vaccine among adults ≥ 65 years of age.
Primary Outcome
Solicited injection site reactions: Pain, Erythema and Swelling. Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia. Grade 3 solicited reactions were defined as: Fever ≥ 39.0°C; Pain, Headache, Malaise and Myalgia, significant, prevents daily activities; Erythema and Swelling \> 100 mm.
Conditions Studied
Interventions
- BIOLOGICAL Influenza Virus Vaccine: Fluzone® 2011-2012 Formulation
- BIOLOGICAL Influenza Virus Vaccine: Fluzone® High-Dose 2011-2012 Formulation
Study Locations (6)
Colorado
- - Colorado Springs
Iowa
- - Council Buffs
Louisiana
- - Metairie
Missouri
- - Springfield
Pennsylvania
- - Bensalem
Texas
- - Austin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2011-09 |
| Est. Completion | 2012-02 |
| Phase | Phase 4 |
What the finished NCT01430819 record still lists
NCT01430819 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, below the 36,802-participant average among 156 other Influenza trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Influenza appearing as the primary indexed condition, and to 2 interventions - of which Influenza Virus Vaccine: Fluzone® 2011-2012 Formulation is the first listed.
NCT01430819 lists 6 locations in 6 states (Colorado, Iowa, Louisiana).
Frequently Asked Questions
What is clinical trial NCT01430819 about?
NCT01430819 is a clinical study titled "Study of Fluzone® Influenza Virus Vaccine 2011-2012 Formulation (Intramuscular Route) Among Adults". The aim of the study is to evaluate the safety and immunogenicity of the 2011-2012 formulation of Fluzone and Fluzone High-Dose vaccines in participants aged 65 years and older. Objectives: * To describe the safety of Fluzone vaccine and Fluzone High-Dose vaccine among adults ≥ 65 years of age. * ...
What is the current status of trial NCT01430819?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 300 participants. The study started on 2011-09. Estimated completion is 2012-02.
What conditions does trial NCT01430819 study?
This clinical trial studies the following conditions: Influenza.
What interventions are being tested in trial NCT01430819?
The interventions under investigation include: Influenza Virus Vaccine: Fluzone® 2011-2012 Formulation (BIOLOGICAL), Influenza Virus Vaccine: Fluzone® High-Dose 2011-2012 Formulation (BIOLOGICAL).
Who is sponsoring clinical trial NCT01430819?
This trial is sponsored by Sanofi Pasteur, a Sanofi Company, which has 153 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01430819 being conducted?
This trial has 6 study locations across Colorado, Iowa, Louisiana, Missouri, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Influenza
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01430819's enrollment target sits among peer trials
300 67th of 156 higher than 85 of 156 other Influenza trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Influenza 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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