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NCT01691339 · ClinicalTrials.gov registry record · Phase 4
Study of Fluzone® Influenza Virus Vaccines 2012-2013 Formulation Among Adults.
A Phase 4 study, sponsored by Sanofi Pasteur, a Sanofi Company.
- Completed
- Registry status
- Phase 4
- Development phase
- 200
- Enrollment target
NCT01691339: Completed Phase 4 study, sponsored by Sanofi Pasteur, a Sanofi Company.
NCT01691339 is a Phase 4 study that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 200 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (61% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01691339, a Phase 4 study, has completed, sponsored by Sanofi Pasteur, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 200 participants
- Enrollment target
Study Summary
The aim of this study is to evaluate the safety and immunogenicity of Fluzone vaccine (18 years to \<65 years of age and ≥ 65 years of age), Fluzone Intradermal vaccine (18 years to \<65 years of age), and Fluzone High-Dose vaccine (≥ 65 years of age). Primary Objective: * To describe the safety of the 2012 - 2013 formulation of Fluzone and Fluzone Intradermal vaccines in adults 18 to \< 65 years of age and the safety of the 2012 - 2013 formulation of Fluzone and Fluzone High-Dose vaccines in adults ≥ 65 years of age. Observational Objectives: * To describe the immunogenicity of the 2012 - 2013 formulation of Fluzone and Fluzone Intradermal vaccines in adults 18 to \< 65 years of age and the immunogenicity of the 2012 - 2013 formulation of Fluzone and Fluzone High-Dose vaccines in adults ≥ 65 years of age. * To evaluate the compliance, in terms of immunogenicity, of each study vaccine (Fluzone, Fluzone Intradermal, and Fluzone High-Dose) in the applicable age group with the requirements of the Committee for Human Medicinal Products (CHMP) Note for Guidance (NfG) CPMP/BWP/214/96. * To submit remaining available sera from subjects given Fluzone vaccine 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 selection and recommendation of strains for subsequent years' influenza vaccines.
Primary Outcome
Solicited injection site: Pain, Erythema, Swelling, Induration, and Ecchymosis; Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering. Grade 3 injection site: Pain - Significant, prevents daily activity; Erythema, Swelling, Induration, and Ecchymosis - \>100 mm. Grade 3 systemic reactions: Fever ≥39.0°C; Headache, Malaise, Myalgia, and Shivering - significant, prevents daily activity.
Interventions
- BIOLOGICAL Influenza Virus Vaccine: Fluzone® 2012-2013 Formulation
- BIOLOGICAL Influenza Virus Vaccine: Fluzone® Intradermal 2012-2013 Formulation
- BIOLOGICAL Influenza Virus Vaccine: Fluzone® High-Dose 2012-2013 Formulation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2012-09 |
| Est. Completion | 2013-02 |
| Phase | Phase 4 |
What the finished NCT01691339 record still lists
NCT01691339 is an interventional study that assigns participants to a tested intervention. The registered 200 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 (61% lower).
The record links to 0 conditions, and to 3 interventions - of which Influenza Virus Vaccine: Fluzone® 2012-2013 Formulation is the first listed.
NCT01691339 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01691339 about?
NCT01691339 is a clinical study titled "Study of Fluzone® Influenza Virus Vaccines 2012-2013 Formulation Among Adults.". The aim of this study is to evaluate the safety and immunogenicity of Fluzone vaccine (18 years to \<65 years of age and ≥ 65 years of age), Fluzone Intradermal vaccine (18 years to \<65 years of age), and Fluzone High-Dose vaccine (≥ 65 years of age). Primary Objective: * To describe the safety o...
What is the current status of trial NCT01691339?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 200 participants. The study started on 2012-09. Estimated completion is 2013-02.
What interventions are being tested in trial NCT01691339?
The interventions under investigation include: Influenza Virus Vaccine: Fluzone® 2012-2013 Formulation (BIOLOGICAL), Influenza Virus Vaccine: Fluzone® Intradermal 2012-2013 Formulation (BIOLOGICAL), Influenza Virus Vaccine: Fluzone® High-Dose 2012-2013 Formulation (BIOLOGICAL).
Who is sponsoring clinical trial NCT01691339?
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 NCT01691339's enrollment target sits among peer trials
200 407th of 2000 higher than 1,556 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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