Trials / Completed
CompletedNCT02587221
Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of an MF59-Adjuvanted Quadrivalent Influenza Vaccine Compared to Non-influenza Vaccine Comparator in Adults ≥ 65 Years of Age
A Phase III, Randomized, Observer-Blind, Controlled, Multicenter Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of an MF59-Adjuvanted Quadrivalent Influenza Vaccine Compared to Non-influenza Vaccine Comparator in Adults ≥ 65 Years of Age
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 6,790 (actual)
- Sponsor
- Seqirus · Industry
- Sex
- All
- Age
- 65 Years
- Healthy volunteers
- Accepted
Summary
A Phase III, Randomized, Observer-Blind, Controlled, Multicenter Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of an MF59-Adjuvanted Quadrivalent Influenza Vaccine Compared to Non-influenza Vaccine Comparator in Adults ≥ 65 Years of Age.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | MF59-adjuvanted Quadrivalent Subunit Inactivated Egg-derived Influenza Vaccine (aQIV) | 1 dose approximately 0.5 mL of aQIV |
| BIOLOGICAL | Non-Influenza Comparator (Boostrix) | 1 dose approximately 0.5 mL dose of Non-influenza comparator vaccine (Boostrix) |
Timeline
- Start date
- 2016-09-30
- Primary completion
- 2018-07-23
- Completion
- 2018-07-23
- First posted
- 2015-10-27
- Last updated
- 2020-06-17
- Results posted
- 2020-06-09
Locations
89 sites across 12 countries: Bulgaria, Colombia, Czechia, Estonia, Latvia, Lithuania, Malaysia, Philippines, Poland, Romania, Thailand, Turkey (Türkiye)
Source: ClinicalTrials.gov record NCT02587221. Inclusion in this directory is not an endorsement.