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NCT03282240 · ClinicalTrials.gov registry record · Phase 3
Safety and Immunogenicity of High-Dose Quadrivalent Influenza Vaccine in Participants ≥65 Years in the US
A Phase 3 study, sponsored by Sanofi Pasteur, a Sanofi Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 2,670
- Enrollment target
NCT03282240: Completed Phase 3 study, sponsored by Sanofi Pasteur, a Sanofi Company.
NCT03282240 is a Phase 3 study that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 2,670 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (246% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03282240, a Phase 3 study, has completed, sponsored by Sanofi Pasteur, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 2,670 participants
- Enrollment target
Study Summary
This randomized, modified double-blind, active-controlled, multi-center trial assessed the safety and immunogenicity of the high-dose quadrivalent influenza vaccine (QIV-HD) compared to either the licensed or investigational high-dose trivalent influenza vaccine (TIV-HD) in adults.
Primary Outcome
GMTs of anti-influenza antibodies were measured using an hemagglutination inhibition (HAI) assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage (B1), and B Yamagata lineage (B2). For each A strain, the comparison was made with the pooled TIV-HD groups. For each B strain, the comparison was made with the TIV-HD group containing the corresponding B strain. TIV-HD 1 did not contain B2 strain; TIV-HD2 did not contain B1 strain.
Interventions
- BIOLOGICAL QIV-HD
- BIOLOGICAL Licensed TIV-HD1
- BIOLOGICAL Investigational TIV-HD2
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,670 participants |
| Start Date | 2017-09-08 |
| Est. Completion | 2018-04-19 |
| Phase | Phase 3 |
What the finished NCT03282240 record still lists
NCT03282240 is an interventional study that assigns participants to a tested intervention. Its 2,670 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 (246% higher).
The record links to 0 conditions, and to 3 interventions - of which QIV-HD is the first listed.
NCT03282240 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03282240 about?
NCT03282240 is a clinical study titled "Safety and Immunogenicity of High-Dose Quadrivalent Influenza Vaccine in Participants ≥65 Years in the US". This randomized, modified double-blind, active-controlled, multi-center trial assessed the safety and immunogenicity of the high-dose quadrivalent influenza vaccine (QIV-HD) compared to either the licensed or investigational high-dose trivalent influenza vaccine (TIV-HD) in adults.
What is the current status of trial NCT03282240?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,670 participants. The study started on 2017-09-08. Estimated completion is 2018-04-19.
What interventions are being tested in trial NCT03282240?
The interventions under investigation include: QIV-HD (BIOLOGICAL), Licensed TIV-HD1 (BIOLOGICAL), Investigational TIV-HD2 (BIOLOGICAL).
Who is sponsoring clinical trial NCT03282240?
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 NCT03282240's enrollment target sits among peer trials
2,670 84th of 2000 higher than 1,917 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
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