Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01162122 · ClinicalTrials.gov registry record · Phase 3
Safety and Immunogenicity of MF59C.1 Adjuvanted Trivalent Subunit Influenza Vaccine in Elderly Subjects
A Phase 3 study, sponsored by Novartis Vaccines.
- Completed
- Registry status
- Phase 3
- Development phase
- 7,109
- Enrollment target
NCT01162122: Completed Phase 3 study, sponsored by Novartis Vaccines.
NCT01162122 is a Phase 3 study that has completed, run by Novartis Vaccines. The registered enrollment target is 7,109 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (821% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01162122, a Phase 3 study, has completed, sponsored by Novartis Vaccines.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 7,109 participants
- Enrollment target
Study Summary
The present phase III study aims to evaluate the safety and immunogenicity of MF59-adjuvanted subunit seasonal influenza vaccine and to evaluate the consistency in the manufacturing process of three consecutive lots of MF59-adjuvanted subunit seasonal influenza vaccine with respect to immunogenicity in subjects aged 65 years and older. The active comparator non-adjuvanted seasonal influenza vaccine is approved for use in this age group in the United States and will be used to provide a comparative assessment for immunogenicity and safety.
Primary Outcome
Immunologic equivalence of 3 consecutive production lots of aTIV (Lot 1, Lot 2 and Lot 3), was assessed in terms of Hemagglutination Inhibition (HI) Geometric Mean Titers (GMTs) in subjects, at three weeks after vaccination, against each vaccine strain.
Interventions
- BIOLOGICAL MF59 adjuvanted trivalent subunit influenza vaccine (aTIV)
- BIOLOGICAL Non-adjuvanted trivalent subunit influenza vaccine (TIV)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7,109 participants |
| Start Date | 2010-08 |
| Est. Completion | 2011-11 |
| Phase | Phase 3 |
What the finished NCT01162122 record still lists
NCT01162122 is an interventional study that assigns participants to a tested intervention. Its 7,109 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 (821% higher).
The record links to 0 conditions, and to 2 interventions - of which MF59 adjuvanted trivalent subunit influenza vaccine (aTIV) is the first listed.
NCT01162122 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01162122 about?
NCT01162122 is a clinical study titled "Safety and Immunogenicity of MF59C.1 Adjuvanted Trivalent Subunit Influenza Vaccine in Elderly Subjects". The present phase III study aims to evaluate the safety and immunogenicity of MF59-adjuvanted subunit seasonal influenza vaccine and to evaluate the consistency in the manufacturing process of three consecutive lots of MF59-adjuvanted subunit seasonal influenza vaccine with respect to immunogenicity...
What is the current status of trial NCT01162122?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 7,109 participants. The study started on 2010-08. Estimated completion is 2011-11.
What interventions are being tested in trial NCT01162122?
The interventions under investigation include: MF59 adjuvanted trivalent subunit influenza vaccine (aTIV) (BIOLOGICAL), Non-adjuvanted trivalent subunit influenza vaccine (TIV) (BIOLOGICAL).
Who is sponsoring clinical trial NCT01162122?
This trial is sponsored by Novartis Vaccines, which has 32 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01162122's enrollment target sits among peer trials
7,109 34th of 2000 higher than 1,967 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT06843720 · 7,100 participants · NA
Expanding Access to Cervical Cancer Screening Through Primary HR-HPV Testing and Self-sampling: a Multicomponent Intervention for Safety Net Health Systems
- NCT05049837 · 7,200 participants
PROSPECT - Profiling of Resistance Patterns & Oncogenic Signaling Pathways in Evaluation of Cancers of the Thorax and Therapeutic Target Identification
- NCT06714929 · 7,200 participants · NA
Advancing Water Security: A Community Participatory School-Based Hydration Intervention
- NCT00260585 · 7,000 participants
Esophageal Cancer Risk Registry
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia