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 is a Phase 3 study that has completed, run by Novartis Vaccines. The registered enrollment target is 7,109 participants.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01162122
The ClinicalTrials.gov registry entry for NCT01162122 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 7,109 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Vaccines, which has 32 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which MF59 adjuvanted trivalent subunit influenza vaccine (aTIV) is the first listed.
NCT01162122 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.