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NCT02255409 · ClinicalTrials.gov registry record · Phase 3
Clinical Study to Evaluate Safety, Immunogenicity of Investigational Flu Vaccine Compared to an Approved Flu Vaccine (QIV) in Children Previously Vaccinated in Trial V118_05
A Phase 3 study, sponsored by Seqirus.
- Completed
- Registry status
- Phase 3
- Development phase
- 607
- Enrollment target
NCT02255409: Completed Phase 3 study, sponsored by Seqirus.
NCT02255409 is a Phase 3 study that has completed, run by Seqirus. The registered enrollment target is 607 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (21% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02255409, a Phase 3 study, has completed, sponsored by Seqirus.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 607 participants
- Enrollment target
Study Summary
Safety, Immunogenicity of an Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine Compared to Non-Adjuvanted Comparator Influenza Vaccine in Children Previously Vaccinated in Trial V118\_05
Primary Outcome
Safety was assessed in terms of number of subjects between 12 months and 7 years of age reporting unsolicited events up to 12 months after last vaccination with either aQIV or QIV (comparator): serious adverse events (SAEs), AEs leading to study withdrawal, new onset chronic disease (NOCDs), adverse events of special interest (AESIs) and medically attended AEs after vaccination.
Interventions
- BIOLOGICAL Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)
- BIOLOGICAL non-adjuvanted Quadrivalent Influenza Vaccine (QIV)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 607 participants |
| Start Date | 2014-10 |
| Est. Completion | 2016-01 |
| Phase | Phase 3 |
What the finished NCT02255409 record still lists
NCT02255409 is an interventional study that assigns participants to a tested intervention. The registered 607 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (21% lower).
The record links to 0 conditions, and to 2 interventions - of which Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV) is the first listed.
NCT02255409 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02255409 about?
NCT02255409 is a clinical study titled "Clinical Study to Evaluate Safety, Immunogenicity of Investigational Flu Vaccine Compared to an Approved Flu Vaccine (QIV) in Children Previously Vaccinated in Trial V118_05". Safety, Immunogenicity of an Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine Compared to Non-Adjuvanted Comparator Influenza Vaccine in Children Previously Vaccinated in Trial V118\_05
What is the current status of trial NCT02255409?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 607 participants. The study started on 2014-10. Estimated completion is 2016-01.
What interventions are being tested in trial NCT02255409?
The interventions under investigation include: Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV) (BIOLOGICAL), non-adjuvanted Quadrivalent Influenza Vaccine (QIV) (BIOLOGICAL).
Who is sponsoring clinical trial NCT02255409?
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 NCT02255409's enrollment target sits among peer trials
607 605th of 2000 higher than 1,395 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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