drugset
drugset / Trial / NCT04551677

Annual Study for Collection of Serum Samples in Children and Older Adults Receiving the 2020-2021 Formulations of Fluzone Quadrivalent Vaccine and Fluzone High-Dose Quadrivalent Vaccine, Respectively

NCT04551677 ↗

Phase 4 Completed 90 enrolled Sanofi Pasteur, a Sanofi Company
Non-randomizedParallel-groupOpen-labelOther

Summary

Primary Objective: To provide serum samples (collected from participants before vaccination \[Blood Sample 1\] and after final vaccination \[Blood Sample 2\]) to Center for Biologics Evaluation and Research (CBER) for further analysis by the World Health Organization (WHO), Centers for Disease Control and Prevention (CDC), and Food and Drug Administration (FDA) to support formulation recommendations for subsequent influenza vaccines. In addition, serum samples from adult participants may be further analyzed by the Sponsor to assess breadth of immune response induced by the study vaccines.

Timeline

Start
2020-09-16
Primary completion
2020-12-18
Completion
2020-12-18

Drugs

EvaluationDrugModalityDoseRoute
Subject Fluzone High-Dose Quadrivalent vaccine Vaccine 0.7 ml Intramuscular
Subject Fluzone Quadrivalent vaccine Vaccine 0.5 ml Intramuscular

Indications

No indication recorded.