Trials / Completed
CompletedNCT03314662
Phase 3 Safety and Immunogenicity Study of aQIV in Elderly Adults
A Phase 3, Randomized, Double-Blind, Controlled, Multicenter, Clinical Study to Evaluate Safety and Immunogenicity of an MF59-Adjuvanted Quadrivalent Subunit Influenza Vaccine in Comparison With an MF59-Adjuvanted Trivalent Subunit Influenza Vaccine and an MF59-Adjuvanted Trivalent Subunit Influenza Vaccine Containing the Alternate B Strain, in Adults Aged 65 Years and Above
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,778 (actual)
- Sponsor
- Seqirus · Industry
- Sex
- All
- Age
- 65 Years
- Healthy volunteers
- Accepted
Summary
This phase 3 study is a randomized, double-blinded, comparator controlled, parallel-group, multicenter study of aQIV versus the US-licensed 2017-2018 adjuvanted trivalent influenza vaccine (aTIV-1, Fluad), and versus an adjuvanted trivalent influenza vaccine (aTIV-2), containing the alternate B strain.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | MF59-adjuvanted Quadrivalent Subunit Inactivated Egg-derived Influenza Vaccine (aQIV) | The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for quadrivalent vaccines. |
| BIOLOGICAL | Licensed MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine (aTIV-1) | The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for trivalent vaccines. |
| BIOLOGICAL | MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine Containing the Alternate B Strain (aTIV-2) | The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for trivalent vaccines except the B strain present in this vaccine is the second/alternate B strain recommended for inclusion in quadrivalent vaccines (ie, Alternate B strain). |
Timeline
- Start date
- 2017-10-17
- Primary completion
- 2017-12-11
- Completion
- 2018-05-17
- First posted
- 2017-10-19
- Last updated
- 2020-07-22
- Results posted
- 2020-07-22
Locations
20 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03314662. Inclusion in this directory is not an endorsement.