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NCT01773928 · ClinicalTrials.gov registry record · Phase 3
Inactivated Split Virus Seasonal Influenza Vaccine (Vero Cell-Derived)
A Phase 3 study, sponsored by Alachua Government Services.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,928
- Enrollment target
NCT01773928: Completed Phase 3 study, sponsored by Alachua Government Services.
NCT01773928 is a Phase 3 study that has completed, run by Alachua Government Services. The registered enrollment target is 1,928 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (150% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01773928, a Phase 3 study, has completed, sponsored by Alachua Government Services.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,928 participants
- Enrollment target
Study Summary
The purpose of this study is to determine if a Vero cell-derived trivalent seasonal influenza vaccine produced by the modified manufacturing process: 1. induces immune responses comparable to that produced by the current manufacturing process 2. has an acceptable safety profile compared to a licensed trivalent seasonal influenza vaccine 3. demonstrates consistency of immune response among three different lots.
Primary Outcome
Hemagglutination Inhibition Antibody (HIA) Titer for Each of the Three Antigens Contained in the Vaccine Two co-primary analyses relating to this primary immunogenicity outcome measure were also performed: Outcome Measure 2 - Noninferiority Outcome Measure 3 - Lot Consistency
Interventions
- BIOLOGICAL Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
- BIOLOGICAL VCIV manufactured with the current manufacturing process (VCIV current)
- BIOLOGICAL Fluzone®, licensed trivalent influenza vaccine (TIV)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,928 participants |
| Start Date | 2013-01 |
| Est. Completion | 2013-04 |
| Phase | Phase 3 |
What the finished NCT01773928 record still lists
NCT01773928 is an interventional study that assigns participants to a tested intervention. Its 1,928 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 (150% higher).
The record links to 0 conditions, and to 3 interventions - of which Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified) is the first listed.
NCT01773928 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01773928 about?
NCT01773928 is a clinical study titled "Inactivated Split Virus Seasonal Influenza Vaccine (Vero Cell-Derived)". The purpose of this study is to determine if a Vero cell-derived trivalent seasonal influenza vaccine produced by the modified manufacturing process: 1. induces immune responses comparable to that produced by the current manufacturing process 2. has an acceptable safety profile compared to a licens...
What is the current status of trial NCT01773928?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,928 participants. The study started on 2013-01. Estimated completion is 2013-04.
What interventions are being tested in trial NCT01773928?
The interventions under investigation include: Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified) (BIOLOGICAL), VCIV manufactured with the current manufacturing process (VCIV current) (BIOLOGICAL), Fluzone®, licensed trivalent influenza vaccine (TIV) (BIOLOGICAL).
Who is sponsoring clinical trial NCT01773928?
This trial is sponsored by Alachua Government Services, which has 12 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01773928's enrollment target sits among peer trials
1,928 109th of 2000 higher than 1,892 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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