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

Collection of Serum Samples From Children 6 Months to < 9 Years of Age Who Received Fluzone® Quadrivalent and Adults ≥ 65 Years of Age Who Received Fluzone® High-Dose Quadrivalent, Influenza Vaccines, 2021-2022 Formulations

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 6 Months
• Healthy volunteers: Accepted

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.

Detailed description

Study duration per participant was approximately 28 days for participants with 6 months to \< 9 years of age, and 21 days for participants \>= 65 years of age, including 1 to 3 visits (1 or 2 vaccination visits) and 1 or 2 telephone calls, depending on study Group.

Conditions

• Influenza Immunization
• Healthy Volunteers

Interventions

Type	Name	Description
BIOLOGICAL	Fluzone Quadrivalent vaccine, No Preservative (0.5-mL dose), 2021-2022 formulation	Suspension for injection in a pre-filled syringe Route of administration: Intramuscular (IM)
BIOLOGICAL	Fluzone High-Dose Quadrivalent vaccine (0.7-mL dose), 2021-2022 formulation	Suspension for injection in a pre-filled syringe Route of administration: Intramuscular (IM)

Timeline

• Start date: 2021-09-08
• Primary completion: 2021-11-10
• Completion: 2021-11-10
• First posted: 2021-09-20
• Last updated: 2025-09-12
• Results posted: 2022-09-14

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study