Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01712984 · ClinicalTrials.gov registry record · Phase 3
Study of Intradermal Quadrivalent Influenza Vaccine in Adults Aged 18 Through 64 Years
A Phase 3 study, sponsored by Sanofi Pasteur, a Sanofi Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 3,360
- Enrollment target
NCT01712984: Completed Phase 3 study, sponsored by Sanofi Pasteur, a Sanofi Company.
NCT01712984 is a Phase 3 study that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 3,360 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (335% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01712984, a Phase 3 study, has completed, sponsored by Sanofi Pasteur, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 3,360 participants
- Enrollment target
Study Summary
The aim of the study is to demonstrate safety and immunogenicity of the quadrivalent influenza intradermal (QIV-ID) vaccine compared to the trivalent influenza vaccine (TIV) containing the B strain from the primary (Yamagata) lineage (TIV-ID1) and the trivalent influenza vaccine containing B strain from the alternate (Victoria) lineage (TIV-ID2) vaccines in producing protection against four strains of influenza virus. Primary Objective: * To demonstrate that QIV-ID induces an immune response (as assessed by hemagglutination inhibition (HAI) geometric mean titers (GMTs) and seroconversion rates) that is non-inferior to responses induced by TIV-ID1 and TIV-ID2 for the 4 virus strains at 28 days post-vaccination. Secondary Objectives: * To demonstrate that each B strain in QIV-ID induces an immune response (as assessed by HAI GMTs and seroconversion rates) that is superior to the response induced by the TIV-ID that does not contain the corresponding B strain. * To describe the rate of post-vaccination seroprotection induced by QIV-ID and TIV-ID. * To describe post-vaccination immunogenicity stratified by age (18-49 years and 50-64 years), race, ethnicity, gender, previous vaccination status, and baseline seropositivity status. * To describe the safety profile for subjects who receive QIV-ID and TIV-ID. Observational Objectives: * To demonstrate non-inferiority of QIV-ID compared to TIV-ID in terms of all Grade 2 or Grade 3 solicited systemic reactions combined * To demonstrate non-inferiority of QIV-ID compared to TIV-ID in terms of all Grade 3 solicited injection site reactions combined.
Primary Outcome
Antibodies against the influenza vaccine virus antigens were measured using a Hemagglutination-inhibition (HAI) assay.
Interventions
- BIOLOGICAL Influenza Virus Vaccine USP Quadrivalent, (Zonal Purified Subvirion) 2012 2013 Formulation
- BIOLOGICAL Influenza Virus Vaccine USP Trivalent Types A and B (Zonal Purified Subvirion) Fluzone® Intradermal
- BIOLOGICAL Influenza Virus Vaccine USP Trivalent Types A and B (Zonal Purified Subvirion) Fluzone Intradermal
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,360 participants |
| Start Date | 2012-10 |
| Est. Completion | 2013-10 |
| Phase | Phase 3 |
What the finished NCT01712984 record still lists
NCT01712984 is an interventional study that assigns participants to a tested intervention. Its 3,360 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (335% higher).
The record links to 0 conditions, and to 3 interventions - of which Influenza Virus Vaccine USP Quadrivalent, (Zonal Purified Subvirion) 2012 2013 Formulation is the first listed.
NCT01712984 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01712984 about?
NCT01712984 is a clinical study titled "Study of Intradermal Quadrivalent Influenza Vaccine in Adults Aged 18 Through 64 Years". The aim of the study is to demonstrate safety and immunogenicity of the quadrivalent influenza intradermal (QIV-ID) vaccine compared to the trivalent influenza vaccine (TIV) containing the B strain from the primary (Yamagata) lineage (TIV-ID1) and the trivalent influenza vaccine containing B strain ...
What is the current status of trial NCT01712984?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 3,360 participants. The study started on 2012-10. Estimated completion is 2013-10.
What interventions are being tested in trial NCT01712984?
The interventions under investigation include: Influenza Virus Vaccine USP Quadrivalent, (Zonal Purified Subvirion) 2012 2013 Formulation (BIOLOGICAL), Influenza Virus Vaccine USP Trivalent Types A and B (Zonal Purified Subvirion) Fluzone® Intradermal (BIOLOGICAL), Influenza Virus Vaccine USP Trivalent Types A and B (Zonal Purified Subvirion) Fluzone Intradermal (BIOLOGICAL).
Who is sponsoring clinical trial NCT01712984?
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 NCT01712984's enrollment target sits among peer trials
3,360 72nd of 2000 higher than 1,929 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT06880055 · 3,375 participants
Shield Post-Approval Study Protocol
- NCT03474029 · 3,400 participants · Phase 2
Assessment of the Safety, Tolerability, and Effectiveness of Rifapentine Given Daily for LTBI
- NCT07142954 · 3,400 participants · Phase 3
Epidemiology and Biomarker Study in Alzheimer's Disease
- NCT03674307 · 3,306 participants · NA
Screening for Asymptomatic Coronary Artery Disease in Kidney Transplant Candidates
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia