drugset / Trial / NCT04109222
Collection of Serum Samples From Children and Older Adults Receiving the 2019-2020 Formulations of Fluzone® Quadrivalent and Fluzone® High-Dose Influenza Vaccines, Respectively
Non-randomizedParallel-groupOpen-labelOther
Summary
The primary objective of the study was to provide sera (collected from participants before vaccination \[Blood Sample 1\] and after final vaccination \[Blood Sample 2\]) to the Center for Biologics Evaluation and Research (CBER) for further analysis by the World Health Organization (WHO), the Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA) to support formulation recommendations for subsequent influenza vaccines.
Timeline
- Start
- 2019-09-30
- Primary completion
- 2019-12-10
- Completion
- 2019-12-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fluzone High-Dose vaccine | Vaccine | 0.5 ml | Intramuscular |
| Subject | Fluzone Quadrivalent vaccine | Vaccine | 0.5 ml | Intramuscular |