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NCT01964989 · ClinicalTrials.gov registry record · Phase 3
Clinical Study to Evaluate the Safety, Immunogenicity and Efficacy of Investigational Flu Vaccine Compared to Approved Flu Vaccine in Children.
A Phase 3 study, sponsored by Seqirus.
- Completed
- Registry status
- Phase 3
- Development phase
- 10,644
- Enrollment target
NCT01964989: Completed Phase 3 study, sponsored by Seqirus.
NCT01964989 is a Phase 3 study that has completed, run by Seqirus. The registered enrollment target is 10,644 participants, above the 771-participant average among 15,282 other Phase 3 trials with a reported enrollment target (1281% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01964989, a Phase 3 study, has completed, sponsored by Seqirus.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 10,644 participants
- Enrollment target
Study Summary
Safety, Immunogenicity and Efficacy of an Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine Compared to Non-Adjuvanted Comparator Influenza Vaccine in Children ≥6 to \<72 Months of Age. The study was conducted during the 2013/2014 and 2014/2015 northern hemisphere influenza season.
Primary Outcome
Relative efficacy of aQIV compared to non-adjuvanted comparator (TIV/QIV) was determined by the number of subjects ≥6 to \<72 months of age with RT-PCR confirmed occurrence of influenza A and/or B of any influenza strain that occurred at ≥21 days and ≤180 days after the last vaccination or until the end of the influenza season, whichever was longer. Efficacy was determined on influenza cases caused by any of the influenza strains related to the two A subtypes and the B lineage(s) common to aQIV
Interventions
- BIOLOGICAL Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)
- BIOLOGICAL Non-adjuvanted Trivalent Influenza Vaccine (TIV) / Quadrivalent Influenza Vaccine (QIV)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10,644 participants |
| Start Date | 2013-11 |
| Est. Completion | 2016-08 |
| Phase | Phase 3 |
What the finished NCT01964989 record still lists
NCT01964989 is an interventional study that assigns participants to a tested intervention. Its 10,644 participants enrollment target places it among the larger protocols in the corpus, above the 771-participant average among 15,282 other Phase 3 trials with a reported enrollment target (1281% higher).
The record links to 0 conditions, and to 2 interventions - of which Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV) is the first listed.
NCT01964989 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01964989 about?
NCT01964989 is a clinical study titled "Clinical Study to Evaluate the Safety, Immunogenicity and Efficacy of Investigational Flu Vaccine Compared to Approved Flu Vaccine in Children.". Safety, Immunogenicity and Efficacy of an Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine Compared to Non-Adjuvanted Comparator Influenza Vaccine in Children ≥6 to \<72 Months of Age. The study was conducted during the 2013/2014 and 2014/2015 northern hemisphere influenza season.
What is the current status of trial NCT01964989?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 10,644 participants. The study started on 2013-11. Estimated completion is 2016-08.
What interventions are being tested in trial NCT01964989?
The interventions under investigation include: Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV) (BIOLOGICAL), Non-adjuvanted Trivalent Influenza Vaccine (TIV) / Quadrivalent Influenza Vaccine (QIV) (BIOLOGICAL).
Who is sponsoring clinical trial NCT01964989?
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 NCT01964989's enrollment target sits among peer trials
10,644 25th of 2000 higher than 1,976 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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