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NCT01946438 · ClinicalTrials.gov registry record · Phase 4
Study of Fluzone® Quadrivalent, Fluzone® Intradermal, and Fluzone® High-Dose Influenza Virus Vaccines in Adults
A Phase 4 study, sponsored by Sanofi Pasteur, a Sanofi Company.
- Completed
- Registry status
- Phase 4
- Development phase
- 208
- Enrollment target
NCT01946438: Completed Phase 4 study, sponsored by Sanofi Pasteur, a Sanofi Company.
NCT01946438 is a Phase 4 study that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 208 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01946438, a Phase 4 study, has completed, sponsored by Sanofi Pasteur, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 208 participants
- Enrollment target
Study Summary
The aim of the study is describe the safety and immunogenicity of Fluzone Quadrivalent and Fluzone Intradermal vaccines in adults 18 to \< 65 years of age, and to describe the safety and immunogenicity of Fluzone Quadrivalent and Fluzone High-Dose vaccines in adults ≥ 65 years of age. Primary Objective: * To describe the safety of the 2013-2014 formulations of Fluzone Quadrivalent and Fluzone Intradermal vaccines in adults 18 to \< 65 years of age and the safety of the 2013-2014 formulations of Fluzone Quadrivalent and Fluzone High-Dose vaccines in adults ≥ 65 years of age. Observational objectives: * To describe the immunogenicity of the 2013-2014 formulations of Fluzone Quadrivalent and Fluzone Intradermal vaccines in adults 18 to \< 65 years of age and the immunogenicity of the 2013-2014 formulations of Fluzone Quadrivalent and Fluzone High-Dose vaccines in adults ≥ 65 years of age. * To evaluate the compliance, in terms of immunogenicity, of each study vaccine (Fluzone Quadrivalent, Fluzone Intradermal, and Fluzone High-Dose) in the applicable age group with the historical requirements of the Committee for Human Medicinal Products (CHMP) Note for Guidance (NfG) CPMP/BWP/214/96. * To submit sera from selected subjects to the Center for Biologics Evaluation and Research (CBER) for further analysis by the World Health Organization (WHO), the Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA) to support formulation recommendations for subsequent influenza vaccines.
Primary Outcome
Solicited injection-site reactions: Pain, Erythema, Swelling, Induration, and Ecchymosis. Systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering. Grade 3: Pain, Significant, prevents daily activity; Erythema, Swelling, Induration, and Ecchymosis, \>100 mm; Fever, ≥102.1°F; Headache, Malaise, Myalgia, and Shivering, Significant, prevents daily activity.
Interventions
- BIOLOGICAL Fluzone® Quadrivalent, Influenza Virus Vaccine (2013-2014 formulation),
- BIOLOGICAL Fluzone® Intradermal, Influenza Virus Vaccine (2013-2014 formulation),
- BIOLOGICAL Fluzone® High-Dose, Influenza Virus Vaccine (2013-2014 formulation)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 208 participants |
| Start Date | 2013-09 |
| Est. Completion | 2014-07 |
| Phase | Phase 4 |
What the finished NCT01946438 record still lists
NCT01946438 is an interventional study that assigns participants to a tested intervention. The registered 208 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 3 interventions - of which Fluzone® Quadrivalent, Influenza Virus Vaccine (2013-2014 formulation), is the first listed.
NCT01946438 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01946438 about?
NCT01946438 is a clinical study titled "Study of Fluzone® Quadrivalent, Fluzone® Intradermal, and Fluzone® High-Dose Influenza Virus Vaccines in Adults". The aim of the study is describe the safety and immunogenicity of Fluzone Quadrivalent and Fluzone Intradermal vaccines in adults 18 to \< 65 years of age, and to describe the safety and immunogenicity of Fluzone Quadrivalent and Fluzone High-Dose vaccines in adults ≥ 65 years of age. Primary Objec...
What is the current status of trial NCT01946438?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 208 participants. The study started on 2013-09. Estimated completion is 2014-07.
What interventions are being tested in trial NCT01946438?
The interventions under investigation include: Fluzone® Quadrivalent, Influenza Virus Vaccine (2013-2014 formulation), (BIOLOGICAL), Fluzone® Intradermal, Influenza Virus Vaccine (2013-2014 formulation), (BIOLOGICAL), Fluzone® High-Dose, Influenza Virus Vaccine (2013-2014 formulation) (BIOLOGICAL).
Who is sponsoring clinical trial NCT01946438?
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 NCT01946438's enrollment target sits among peer trials
208 399th of 2000 higher than 1,600 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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