Trials / Completed
CompletedNCT03694392
Flublok v. Standard Dose Vaccine Effectiveness Among Kaiser Permanente Northern California Adults 18-64 Years
Examining Vaccine Effectiveness (VE) of Flublok Relative to Standard Dose Inactivated Influenza Vaccine Among Kaiser Permanente Northern California Members Aged 18-64 Years
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 2,776,278 (actual)
- Sponsor
- Kaiser Permanente · Academic / Other
- Sex
- All
- Age
- 18 Years – 64 Years
- Healthy volunteers
- Accepted
Summary
The overall objective of this study is to describe the effectiveness of Flublok Quadrivalent vaccine compared to standard dose inactivated influenza vaccine (SD-IIV) in adults 18 through 64 years of age. During this study, Flublok Quadrivalent or SD-IIV will be administered according to the guidelines in the Prescribing Information materials and only to persons for whom it is indicated. The 2018-2019, 2019-2020, and 2020-2021 formulations of recombinant influenza vaccine (Flublok Quadrivalent vaccine) and SD-IIV will be evaluated for outcomes including all polymerase chain reaction (PCR)-confirmed influenza, PCR-confirmed hospitalized influenza, hospitalized community-acquired pneumonia and cardio-respiratory events.
Conditions
- Influenza
- Pneumonia
- Lower Respiratory Tract Infection
- Acute Myocardial Infarction
- Congestive Heart Failure
- Stroke
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Flublok Quadrivalent | Flublok Quadrivalent vaccine is a recombinant hemagglutinin influenza vaccine indicated for active immunization against disease caused by influenza A subtype viruses and type B viruses contained in the vaccine for adults 18 years of age and older. Use of recombinant DNA techniques to produce vaccine antigen expressed in cell culture is a method that avoids growing the influenza viruses in embryonated hen's eggs. |
| BIOLOGICAL | Standard Dose Inactivated Influenza Vaccine (SD-IIV) | For the 2018-2019, 2019-2020, and 2020-2021 flu seasons, the primary SD-IIVs used will be Fluarix Quadrivalent and Flulaval Quadrivalent. |
Timeline
- Start date
- 2018-09-16
- Primary completion
- 2021-04-09
- Completion
- 2022-12-31
- First posted
- 2018-10-03
- Last updated
- 2025-04-08
- Results posted
- 2025-04-08
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03694392. Inclusion in this directory is not an endorsement.