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 is a Phase 3 study that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 3,360 participants.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01712984
The ClinicalTrials.gov registry entry for NCT01712984 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 3,360 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi Pasteur, a Sanofi Company, which has 153 total studies on file at ClinicalTrials.gov.
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 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.