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NCT02212106 · ClinicalTrials.gov registry record · Phase 4
A Study to Evaluate the Safety and Tolerability of Trivalent Influenza Virus Vaccine in Children Aged 5 Years to < 9 Years
A Phase 4 study of Influenza, Human, sponsored by Seqirus.
- Completed
- Registry status
- Phase 4
- Development phase
- 402
- Enrollment target
- 11
- Study locations
NCT02212106: Completed Phase 4 study of Influenza, Human, sponsored by Seqirus.
NCT02212106 is a Phase 4 study of Influenza, Human that has completed, run by Seqirus. The registered enrollment target is 402 participants, below the 16,201-participant average among 18 other Influenza, Human trials with a reported enrollment target (98% lower). The trial reports 11 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02212106, a Phase 4 study of Influenza, Human, has completed, sponsored by Seqirus.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 402 participants
- Enrollment target
- 11
- Study locations
Study Summary
This is a study to assess the safety of a bioCSL split virion, inactivated Trivalent Influenza Virus vaccine containing the 2014/2015 Northern Hemisphere strains of vaccine in children aged 5 years to less than 9 years. Comparison will be made to a licensed Quadrivalent Influenza Virus vaccine that complies with the FDA recommendations for the 2014/2015 influenza season in the US.
Primary Outcome
The overall percentage of subjects reporting at least one fever event after administration of bioCSL TIV. A fever event was defined as an oral temperature ≥ 38°C (≥ 100.4°F). The intensity was calculated as follows: • Mild: ≥ 100.4 to \< 101.3°F (≥ 38.0 to \< 38.5°C) • Moderate: ≥ 101.3 to \< 102.2°F (≥ 38.5 to \< 39.0°C) • Severe: ≥ 102.2°F (≥ 39.0°C)
Conditions Studied
Interventions
- BIOLOGICAL bioCSL Trivalent Influenza Virus Vaccine (CSL TIV)
- BIOLOGICAL Comparator Quadrivalent Influenza Virus Vaccine
Study Locations (11)
North Carolina
- Site 290 - Durham
- Site 281 - Raleigh
- Site 280 - Winston-Salem
Texas
- Site 283 - Austin
- Site 282 - Fort Worth
- Site 288 - San Angelo
California
- Site 286 - Los Angeles
Idaho
- Site 289 - Boise
Missouri
- Site 287 - St Louis
New York
- Site 285 - Binghamton
South Carolina
- Site 284 - Charleston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 402 participants |
| Start Date | 2014-09 |
| Est. Completion | 2014-12 |
| Phase | Phase 4 |
What the finished NCT02212106 record still lists
NCT02212106 is an interventional study that assigns participants to a tested intervention. The registered 402 participants enrollment target is mid-sized for trials with a published cap, below the 16,201-participant average among 18 other Influenza, Human trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Influenza, Human appearing as the primary indexed condition, and to 2 interventions - of which bioCSL Trivalent Influenza Virus Vaccine (CSL TIV) is the first listed.
NCT02212106 lists 11 locations in 7 states (North Carolina, Texas, California).
Frequently Asked Questions
What is clinical trial NCT02212106 about?
NCT02212106 is a clinical study titled "A Study to Evaluate the Safety and Tolerability of Trivalent Influenza Virus Vaccine in Children Aged 5 Years to < 9 Years". This is a study to assess the safety of a bioCSL split virion, inactivated Trivalent Influenza Virus vaccine containing the 2014/2015 Northern Hemisphere strains of vaccine in children aged 5 years to less than 9 years. Comparison will be made to a licensed Quadrivalent Influenza Virus vaccine that ...
What is the current status of trial NCT02212106?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 402 participants. The study started on 2014-09. Estimated completion is 2014-12.
What conditions does trial NCT02212106 study?
This clinical trial studies the following conditions: Influenza, Human.
What interventions are being tested in trial NCT02212106?
The interventions under investigation include: bioCSL Trivalent Influenza Virus Vaccine (CSL TIV) (BIOLOGICAL), Comparator Quadrivalent Influenza Virus Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT02212106?
This trial is sponsored by Seqirus, which has 25 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02212106 being conducted?
This trial has 11 study locations across California, Idaho, Missouri, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02212106's enrollment target sits among peer trials
402 13th of 18 higher than 6 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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