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drugset / Trial / NCT05050318

Annual Study for Collection of Serum Samples in Children and Older Adults Receiving the 2021-2022 Formulations of Fluzone Quadrivalent Vaccine and Fluzone High-Dose Quadrivalent Vaccine, Respectively

NCT05050318 ↗

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

Summary

This was a phase IV, multi-center, open-label study. The study collected serum samples from children 6 months to less than (\<) 9 years of age who received Fluzone Quadrivalent vaccine and adults greater than or equal to (\>=) 65 years of age who received Fluzone High-Dose Quadrivalent vaccine for submission to CBER to aid in the influenza vaccine strain selection process.

Timeline

Start
2021-09-08
Primary completion
2021-11-10
Completion
2021-11-10

Drugs

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

Indications

No indication recorded.