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NCT02914275 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Immunogenicity and Safety of Seqirus Quadrivalent Influenza Vaccine (QIV) in a Pediatric Population 6 Months Through 59 Months of Age.
A Phase 3 study of Influenza, Human, sponsored by Seqirus.
- Completed
- Registry status
- Phase 3
- Development phase
- 2,250
- Enrollment target
- 20
- Study locations
NCT02914275: Completed Phase 3 study of Influenza, Human, sponsored by Seqirus.
NCT02914275 is a Phase 3 study of Influenza, Human that has completed, run by Seqirus. The registered enrollment target is 2,250 participants, below the 16,099-participant average among 18 other Influenza, Human trials with a reported enrollment target (86% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02914275, a Phase 3 study of Influenza, Human, has completed, sponsored by Seqirus.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 2,250 participants
- Enrollment target
- 20
- Study locations
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 2016/2017 Quadrivalent Influenza Vaccine (comparator QIV) in a healthy pediatric population 6 months through 59 months of age.
Primary Outcome
Noninferiority of Seqirus QIV compared to comparator QIV was assessed by hemagglutination inhibition (HI) antibody geometric mean titer (GMT) 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. B/VIC = B/Victoria B/YAM = B/Yamagata
Conditions Studied
Interventions
- BIOLOGICAL Seqirus Quadrivalent Inactivated Influenza Vaccine
- BIOLOGICAL Comparator Quadrivalent Inactivated Influenza Vaccine
Study Locations (20)
California
- Site 430 - Anaheim
- Site 437 - Anaheim
- Site 423 - Downey
- Site 397 - Ontario
- Site 445 - Paramount
- Site 402 - Sacramento
- Site 425 - San Diego
Kansas
- Site 390 - Augusta
- Site 421 - Newton
- Site 422 - Wichita
Kentucky
- Site 443 - Louisville
- Site 420 - Louisville
- Site 441 - Louisville
Alabama
- Site 434 - Birmingham
- Site 442 - Mobile
Florida
- Site 418 - Miami
- Site 426 - Miami
Louisiana
- Site 393 - Metairie
- Site 436 - Metairie
Idaho
- Site 289 - Meridian
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,250 participants |
| Start Date | 2016-09-27 |
| Est. Completion | 2017-08-11 |
| Phase | Phase 3 |
What the finished NCT02914275 record still lists
NCT02914275 is an interventional study that assigns participants to a tested intervention. Its 2,250 participants enrollment target places it among the larger protocols in the corpus, below the 16,099-participant average among 18 other Influenza, Human trials with a reported enrollment target (86% lower).
The record links to 1 condition, with Influenza, Human appearing as the primary indexed condition, and to 2 interventions - of which Seqirus Quadrivalent Inactivated Influenza Vaccine is the first listed.
NCT02914275 names 20 study sites across 7 states, led by California, Kansas, Kentucky.
Frequently Asked Questions
What is clinical trial NCT02914275 about?
NCT02914275 is a clinical study titled "A Study to Evaluate the Immunogenicity and Safety of Seqirus Quadrivalent Influenza Vaccine (QIV) in a Pediatric Population 6 Months Through 59 Months 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 2016/2017 Quadrivalent Influenza Vaccine (comparator QIV) in a healthy pediatric population 6 months through 59 mo...
What is the current status of trial NCT02914275?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,250 participants. The study started on 2016-09-27. Estimated completion is 2017-08-11.
What conditions does trial NCT02914275 study?
This clinical trial studies the following conditions: Influenza, Human.
What interventions are being tested in trial NCT02914275?
The interventions under investigation include: Seqirus Quadrivalent Inactivated Influenza Vaccine (BIOLOGICAL), Comparator Quadrivalent Inactivated Influenza Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT02914275?
This trial is sponsored by Seqirus, which has 25 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02914275 being conducted?
This trial has 20 study locations across Alabama, California, Florida, Idaho, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Influenza, Human
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02914275's enrollment target sits among peer trials
2,250 4th of 18 higher than 15 of 18 other Influenza, Human trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Influenza, Human 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.
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