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NCT02545543 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Immunogenicity and Safety of Seqirus Quadrivalent Influenza Vaccine (QIV) in a Pediatric Population 5 Through 17 Years of Age
A Phase 3 study, sponsored by Seqirus.
- Completed
- Registry status
- Phase 3
- Development phase
- 2,278
- Enrollment target
NCT02545543: Completed Phase 3 study, sponsored by Seqirus.
NCT02545543 is a Phase 3 study that has completed, run by Seqirus. The registered enrollment target is 2,278 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (195% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02545543, a Phase 3 study, has completed, sponsored by Seqirus.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 2,278 participants
- Enrollment target
Study Summary
This is a study to assess the immune (antibody) response and safety of a Seqirus split virion, inactivated Quadrivalent Influenza Vaccine (Seqirus QIV), in comparison with a US licensed 2015/2016 Quadrivalent Influenza Vaccine (comparator QIV) in a healthy pediatric population 5 through 17 years of age.
Primary Outcome
Noninferiority of Seqirus QIV compared to comparator QIV was assessed by the eight co-primary endpoints of hemagglutination inhibition (HI) antibody geometric mean titer (GMT) and seroconversion rate (SCR) for each viral strain included in the vaccines. The GMT ratio is defined as the geometric mean of the postvaccination HI titer for the US-licensed comparator QIV over the geometric mean of the postvaccination HI titer for Seqirus QIV.
Interventions
- BIOLOGICAL Comparator QIV
- BIOLOGICAL Seqirus QIV
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,278 participants |
| Start Date | 2015-09 |
| Est. Completion | 2016-06 |
| Phase | Phase 3 |
What the finished NCT02545543 record still lists
NCT02545543 is an interventional study that assigns participants to a tested intervention. Its 2,278 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 (195% higher).
The record links to 0 conditions, and to 2 interventions - of which Comparator QIV is the first listed.
NCT02545543 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02545543 about?
NCT02545543 is a clinical study titled "A Study to Evaluate the Immunogenicity and Safety of Seqirus Quadrivalent Influenza Vaccine (QIV) in a Pediatric Population 5 Through 17 Years of Age". This is a study to assess the immune (antibody) response and safety of a Seqirus split virion, inactivated Quadrivalent Influenza Vaccine (Seqirus QIV), in comparison with a US licensed 2015/2016 Quadrivalent Influenza Vaccine (comparator QIV) in a healthy pediatric population 5 through 17 years of ...
What is the current status of trial NCT02545543?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,278 participants. The study started on 2015-09. Estimated completion is 2016-06.
What interventions are being tested in trial NCT02545543?
The interventions under investigation include: Comparator QIV (BIOLOGICAL), Seqirus QIV (BIOLOGICAL).
Who is sponsoring clinical trial NCT02545543?
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 NCT02545543's enrollment target sits among peer trials
2,278 94th of 2000 higher than 1,907 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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