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NCT02553343 · ClinicalTrials.gov registry record · Phase 2
A Study of the Safety and Immunogenicity of High-Dose Quadrivalent Influenza Vaccine in Subjects Aged 65 Years and Older
A Phase 2 study, sponsored by Sanofi Pasteur, a Sanofi Company.
- Completed
- Registry status
- Phase 2
- Development phase
- 792
- Enrollment target
NCT02553343 is a Phase 2 study that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 792 participants.
The verdict
NCT02553343, a Phase 2 study, has completed, sponsored by Sanofi Pasteur, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 792 participants
- Enrollment target
Study Summary
The aim of the study is to assess the safety and immunogenicity of two formulations of the high-dose quadrivalent influenza vaccine compared to the licensed high-dose trivalent influenza vaccine control in healthy elderly subjects aged 65 years of age and above. Primary objectives: * To describe the safety profile of all subjects in each study group. * To demonstrate that the high-dose quadrivalent influenza vaccine induces an immune response (as assessed by HAI geometric mean titers (GMTs) that is non-inferior to responses induced by the licensed high-dose trivalent influenza vaccine for the 3 common virus strains at 28 days post-vaccination. Secondary objectives: * To describe post-vaccination immunogenicity for the 4 virus strains (as assessed by seroconversion and seroprotection) for subjects who receive the high-dose quadrivalent influenza vaccine and the licensed high-dose trivalent influenza vaccine. * To describe post-vaccination immunogenicity for the 4 virus strains (as assessed by GMTs, seroconversion, and seroprotection) for subjects who receive the high-dose quadrivalent influenza vaccine and the investigational high-dose trivalent influenza vaccine.
Interventions
- BIOLOGICAL High-dose quadrivalent influenza virus vaccine
- BIOLOGICAL High-dose influenza virus vaccine
- BIOLOGICAL High-dose trivalent inactivated influenza vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 792 participants |
| Start Date | 2015-09 |
| Est. Completion | 2016-04-04 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02553343
The ClinicalTrials.gov registry entry for NCT02553343 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 792 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 High-dose quadrivalent influenza virus vaccine is the first listed.
NCT02553343 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02553343 about?
NCT02553343 is a clinical study titled "A Study of the Safety and Immunogenicity of High-Dose Quadrivalent Influenza Vaccine in Subjects Aged 65 Years and Older". The aim of the study is to assess the safety and immunogenicity of two formulations of the high-dose quadrivalent influenza vaccine compared to the licensed high-dose trivalent influenza vaccine control in healthy elderly subjects aged 65 years of age and above. Primary objectives: * To describe t...
What is the current status of trial NCT02553343?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 792 participants. The study started on 2015-09. Estimated completion is 2016-04-04.
What interventions are being tested in trial NCT02553343?
The interventions under investigation include: High-dose quadrivalent influenza virus vaccine (BIOLOGICAL), High-dose influenza virus vaccine (BIOLOGICAL), High-dose trivalent inactivated influenza vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT02553343?
This trial is sponsored by Sanofi Pasteur, a Sanofi Company, which has 153 total clinical trials registered on ClinicalTrials.gov.
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