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NCT02214225 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Immunogenicity and Safety of bioCSL Quadrivalent Influenza Vaccine (QIV) in Adults Aged 18 Years and Above.
A Phase 3 study, sponsored by Seqirus.
- Completed
- Registry status
- Phase 3
- Development phase
- 3,484
- Enrollment target
NCT02214225: Completed Phase 3 study, sponsored by Seqirus.
NCT02214225 is a Phase 3 study that has completed, run by Seqirus. The registered enrollment target is 3,484 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (351% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02214225, a Phase 3 study, has completed, sponsored by Seqirus.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 3,484 participants
- Enrollment target
Study Summary
This is a study to assess the immune (antibody) response and safety of a bioCSL split virion, inactivated quadrivalent influenza vaccine, in comparison with a US licensed 2014/2015 trivalent influenza vaccine (bioCSL TIV-1), and a trivalent influenza vaccine containing the alternate B strain (bioCSL TIV-2), in healthy adult volunteers aged 18 years and above.
Primary Outcome
Immunogenicity was assessed by measuring HI titers to the four virus strains. Postvaccination GMTs were determined. (GMT dispersion values are based on unadjusted GMT values.) The GMT ratio (defined as the geometric mean of postvaccination (day 21) HI titer for TIV divided by the geometric mean of the postvaccination HI titer for QIV) for each virus strain included in the vaccines was then determined: bioCSL TIV-1 and bioCSL TIV-2 GMTs were pooled for analysis of the A strains.
Interventions
- BIOLOGICAL Quadrivalent Influenza Vaccine (QIV)
- BIOLOGICAL Trivalent Influenza Vaccine (TIV-1)
- BIOLOGICAL Trivalent Influenza Vaccine (TIV-2)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,484 participants |
| Start Date | 2014-08 |
| Est. Completion | 2015-04 |
| Phase | Phase 3 |
What the finished NCT02214225 record still lists
NCT02214225 is an interventional study that assigns participants to a tested intervention. Its 3,484 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 (351% higher).
The record links to 0 conditions, and to 3 interventions - of which Quadrivalent Influenza Vaccine (QIV) is the first listed.
NCT02214225 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02214225 about?
NCT02214225 is a clinical study titled "A Study to Evaluate the Immunogenicity and Safety of bioCSL Quadrivalent Influenza Vaccine (QIV) in Adults Aged 18 Years and Above.". This is a study to assess the immune (antibody) response and safety of a bioCSL split virion, inactivated quadrivalent influenza vaccine, in comparison with a US licensed 2014/2015 trivalent influenza vaccine (bioCSL TIV-1), and a trivalent influenza vaccine containing the alternate B strain (bioCSL...
What is the current status of trial NCT02214225?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 3,484 participants. The study started on 2014-08. Estimated completion is 2015-04.
What interventions are being tested in trial NCT02214225?
The interventions under investigation include: Quadrivalent Influenza Vaccine (QIV) (BIOLOGICAL), Trivalent Influenza Vaccine (TIV-1) (BIOLOGICAL), Trivalent Influenza Vaccine (TIV-2) (BIOLOGICAL).
Who is sponsoring clinical trial NCT02214225?
This trial is sponsored by Seqirus, which has 25 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02214225's enrollment target sits among peer trials
3,484 70th of 2000 higher than 1,931 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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