Trials / Completed
CompletedNCT03617523
Safety and Immunogenicity of Fluzone® Quadrivalent, Flublok® Quadrivalent, and Fluzone® High-Dose, Influenza Vaccines, 2018-2019 Formulations
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 240 (actual)
- Sponsor
- Sanofi Pasteur, a Sanofi Company · Industry
- Sex
- All
- Age
- 6 Months
- Healthy volunteers
- Accepted
Summary
The primary objectives of this study were: * To describe the immunogenicity of the 2018-2019 formulation of Fluzone® Quadrivalent vaccine in children 6 to less than (\<) 36 months of age and 3 to \<9 years of age, and in adults 18 to \<65 years of age; the immunogenicity of the 2018-2019 formulation of Flublok® Quadrivalent vaccine in adults 18 to \<65 years of age; and the immunogenicity of the 2018-2019 formulation of Fluzone High-Dose vaccine in adults greater than or equal to (\>=) 65 years of age. * To describe the safety of the 2018-2019 formulation of Fluzone Quadrivalent vaccine in children 6 to \<36 months of age and 3 to \<9 years of age, and in adults 18 to \<65 years of age; the safety of the 2018-2019 formulation of Flublok Quadrivalent vaccine in adults 18 to \<65 years of age; and the safety of the 2018-2019 formulation of Fluzone High-Dose vaccine in adults \>=65 years of age.
Detailed description
Study duration per participant was approximately 21 days for adult participants or 28 days for child participants who received one dose of vaccine, and 56 days for participants who received two doses of vaccine.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Fluzone Quadrivalent vaccine, 2018-2019 formulation | Pharmaceutical form: Suspension for injection Route of administration: Intramuscular |
| BIOLOGICAL | Flublok Quadrivalent vaccine, 2018-2019 formulation | Pharmaceutical form: Suspension for injection Route of administration: Intramuscular |
| BIOLOGICAL | Fluzone High-Dose vaccine, 2018-2019 formulation | Pharmaceutical form: Suspension for injection Route of administration: Intramuscular |
Timeline
- Start date
- 2018-09-10
- Primary completion
- 2018-11-12
- Completion
- 2018-11-12
- First posted
- 2018-08-06
- Last updated
- 2022-03-29
- Results posted
- 2019-11-25
Locations
3 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03617523. Inclusion in this directory is not an endorsement.