Safety and Immunogenicity of MF59C.1 Adjuvanted Trivalent Subunit Influenza Vaccine in Elderly Subjects
Public ClinicalTrials.gov record NCT01162122. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase III, Randomized, Controlled, Observer-Blind, Multicenter Study to Evaluate the Safety and Immunogenicity and the Consistency of Three Consecutive Lots of a MF59C.1 Adjuvanted Trivalent Subunit Influenza Vaccine in Elderly Subjects Aged 65 Years and Older
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01162122
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 7,109 participants
Conditions and interventions
Conditions
Interventions
- MF59 adjuvanted trivalent subunit influenza vaccine (aTIV) Biological
- Non-adjuvanted trivalent subunit influenza vaccine (TIV) Biological
Biological
Eligibility (public fields only)
- Age range
- 65 Years and older
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 2010 (Type not available)
- Primary completion
- Aug 2011 (Actual)
- Completion
- Nov 2011 (Actual)
- Last update posted
- Jun 26, 2014
2010 – 2011
United States locations
- U.S. sites
- 21
- U.S. states
- 12
- U.S. cities
- 18
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| 301, Tatum Highlands Medical Associates PLLC, 26224 N Tatum Blvd 15A | Phoenix | Arizona | 85253 | — |
| 318 Avail Clinical Research, 860 Peachwood Drive | DeLand | Florida | 32720 | — |
| 306 Westside Center for Clinical Research, 810 Lane Avenue South | Jacksonville | Florida | 32205 | — |
| 328 Miami Research Associates, 6141 Sunset Drive | Miami | Florida | 33143 | — |
| 320 Johnson County Clin-Trials, 15602 College Blvd | Lenexa | Kansas | 66219 | — |
| 316 Heartland Research Associates LLC - Axtell Clinic - PA, 700 Medical Center Dr | Newton | Kansas | 67114 | — |
| 310 Heartland Research Associates LLC, 3730 N Ridge Road Suite 600 | Wichita | Kansas | 67205 | — |
| 322 Heartland Research Associates Wichita, 1709 S. Rock Road | Wichita | Kansas | 67207 | — |
| 314 Saint Louis Univ Med Div of Infectious Diseases Immunology, 1100 S Grand Blvd DRC- Rm 827 | St Louis | Missouri | 63104 | — |
| 330 Mercy Health Research, 12680 Olive Blvd Suite 200 | St Louis | Missouri | 63141 | — |
| 313 Clinical Research Center of Nevada, 7425 W Azure Suite 150 | Las Vegas | Nevada | 89130 | — |
| 311 Regional Clinical Research INC, 415 Hooper Road | Endwell | New York | 13760 | — |
| 326 Triangle Medical Research, 5816 Creedmoor Rd. Suite 104 | Raleigh | North Carolina | 27612 | — |
| 332 Piedmont Medical Research, 1901 S. Hawthorne Rd. Suite 306 | Winston-Salem | North Carolina | 27103 | — |
| 303 Prestige Clinical Research, 333 Conover Drive | Franklin | Ohio | 45005 | — |
| 325 Omega Medical Research, 400 Bald Hill Road | Warwick | Rhode Island | 02886 | — |
| 312 Spartanburg Regional Medical Center, 485 Simuel Road | Spartanburg | South Carolina | 29303 | — |
| 321 Jordan River Family Medicine, 1868 West 9800 South Ste 100 | Jordan | Utah | — | — |
| 317 J. Lewis Research Inc., 2295 Foothill Drive | Salt Lake City | Utah | 84109 | — |
| 305 Foothill Family Clinic South, 6360 South 3000 East | Salt Lake City | Utah | 84121 | — |
| 323 PI Coor Clinical Research LCC, 10721 Main St Suite 1500 | Fairfax | Virginia | 22030 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 17 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01162122, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 26, 2014 · Synced Oct 30, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01162122 live on ClinicalTrials.gov.