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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: Completed Phase 2 study, sponsored by Sanofi Pasteur, a Sanofi Company.
NCT02553343 is a Phase 2 study that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 792 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (495% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Solicited injection site: Pain, Redness, Swelling, Induration, and Ecchymosis. Solicited systemic reaction: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering. Unsolicited adverse events, including serious adverse events, will also be collected
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 |
What the finished NCT02553343 record still lists
NCT02553343 is an interventional study that assigns participants to a tested intervention. The registered 792 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (495% higher).
The record links to 0 conditions, and to 3 interventions - of which High-dose quadrivalent influenza virus vaccine is the first listed.
NCT02553343 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02553343's enrollment target sits among peer trials
792 40th of 2000 higher than 1,961 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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