Trials / Completed
CompletedNCT01685372
Immunogenicity of Fluzone High Dose in Immunocompromised Children and Young Adults
Immunogenicity and Efficacy of High-dose Trivalent Inactivated Seasonal Influenza Vaccine (Fluzone High Dose) in Immunocompromised Children and Young Adults.
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 16 (actual)
- Sponsor
- University of Colorado, Denver · Academic / Other
- Sex
- All
- Age
- 5 Years – 35 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine whether Fluzone High Dose increases the immune response to the influenza antigens contained in the vaccine compared to standard-dose Fluzone in immunocompromised children and young adults. Safety and efficacy data will also be collected.
Conditions
- Solid Organ Transplant Recipient (Liver, Kidney, Heart)
- Rheumatologic Disorder
- Human Immunodeficiency Virus (HIV)
- Bone Marrow Transplant (BMT)
- Dialysis
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Fluzone High Dose | A single-dose of high-dose influenza vaccine will be administered to subjects randomized to this arm |
| BIOLOGICAL | Fluzone | A single-dose of standard-dose influenza vaccine will be administered to subjects randomized to this arm |
Timeline
- Start date
- 2012-09-01
- Primary completion
- 2015-09-01
- Completion
- 2017-09-01
- First posted
- 2012-09-14
- Last updated
- 2018-01-23
- Results posted
- 2017-11-30
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01685372. Inclusion in this directory is not an endorsement.