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NCT03308825 · ClinicalTrials.gov registry record · Phase 4
Safety and Immunogenicity of Fluzone® Quadrivalent and Fluzone® High-Dose, Influenza Vaccines
A Phase 4 study of Influenza and FLU, sponsored by Sanofi Pasteur, a Sanofi Company.
- Completed
- Registry status
- Phase 4
- Development phase
- 240
- Enrollment target
- 3
- Study locations
NCT03308825: Completed Phase 4 study of Influenza and FLU, sponsored by Sanofi Pasteur, a Sanofi Company.
NCT03308825 is a Phase 4 study of Influenza and FLU that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 240 participants, below the 36,802-participant average among 156 other Influenza trials with a reported enrollment target (99% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03308825, a Phase 4 study of Influenza and FLU, has completed, sponsored by Sanofi Pasteur, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 240 participants
- Enrollment target
- 3
- Study locations
Study Summary
The aim of the study was to describe the safety and immunogenicity of the 2017-2018 formulation of Fluzone Quadrivalent vaccine in children 6 months to \< 9 years of age, and in adults 18 to \< 65 years of age, and to describe the safety and immunogenicity of the 2017-2018 formulation of Fluzone High-Dose vaccine in adults ≥ 65 years of age.
Primary Outcome
Solicited injection site reactions: Pain, Erythema and Swelling (Grade 3: Pain: cries when injected limb moved/ limb movement reduced, erythema and swelling \>= 50 mm). Solicited systemic reactions: Fever, vomiting, abnormal crying, drowsiness, appetite lost, Irritability (Grade 3: Fever: \>= 39.5 degrees Celsius \[103.1 degree Fahrenheit {°F}\], vomiting \>= six episodes per 24 hours, abnormal crying : \> 3 hours, drowsiness: sleeping most of the time or difficult to wake up, appetite lost: ref
Interventions
- BIOLOGICAL Fluzone Quadrivalent vaccine
- BIOLOGICAL Fluzone High-Dose vaccine
Study Locations (3)
Iowa
- Sanofi Pasteur Investigational Site 003 - Council Bluffs
Kentucky
- Sanofi Pasteur Investigational Site 002 - Bardstown
Louisiana
- Sanofi Pasteur Investigational Site 001 - Metairie
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 240 participants |
| Start Date | 2017-09-11 |
| Est. Completion | 2017-11-22 |
| Phase | Phase 4 |
What the finished NCT03308825 record still lists
NCT03308825 is an interventional study that assigns participants to a tested intervention. The registered 240 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 2 conditions, with Influenza appearing as the primary indexed condition, and to 2 interventions - of which Fluzone Quadrivalent vaccine is the first listed.
NCT03308825 reports a single indexed study location in Iowa, Kentucky, Louisiana.
Frequently Asked Questions
What is clinical trial NCT03308825 about?
NCT03308825 is a clinical study titled "Safety and Immunogenicity of Fluzone® Quadrivalent and Fluzone® High-Dose, Influenza Vaccines". The aim of the study was to describe the safety and immunogenicity of the 2017-2018 formulation of Fluzone Quadrivalent vaccine in children 6 months to \< 9 years of age, and in adults 18 to \< 65 years of age, and to describe the safety and immunogenicity of the 2017-2018 formulation of Fluzone Hig...
What is the current status of trial NCT03308825?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 240 participants. The study started on 2017-09-11. Estimated completion is 2017-11-22.
What conditions does trial NCT03308825 study?
This clinical trial studies the following conditions: Influenza, FLU.
What interventions are being tested in trial NCT03308825?
The interventions under investigation include: Fluzone Quadrivalent vaccine (BIOLOGICAL), Fluzone High-Dose vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT03308825?
This trial is sponsored by Sanofi Pasteur, a Sanofi Company, which has 153 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03308825 being conducted?
This trial has 3 study locations across Iowa, Kentucky, Louisiana. 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 NCT03308825's enrollment target sits among peer trials
240 77th of 156 higher than 80 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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Safety and Immunogenicity Among Healthy Children Receiving Fluzone® Quadrivalent, Influenza Vaccine
COMPLETED · Phase 4
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