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

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, 2020-2021 Formulations

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 6 Months – 84 Years
• Healthy volunteers: Accepted

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.

Detailed description

Study duration per participant was approximately 28 days for participants 6 months to less than (\<) 9 years of age, and 21 days for participants greater than or equal to (\>=) 65 years of age, including 1 to 3 visits (1 or 2 vaccination visits) and 1 or 2 telephone calls, depending on study Group. The aim of study GRC00101 was to obtain serum samples for submission to CBER to aid in the influenza vaccine strain selection process. There were no outcome measures defined in the protocol; however, the number of collected samples was listed as an outcome for disclosure purposes since outcomes were mandatory for study registration.

Conditions

• Influenza Immunization
• Healthy Volunteers

Interventions

Type	Name	Description
BIOLOGICAL	Fluzone Quadrivalent vaccine, No Preservative (0.5-mL dose), 2020-2021 formulation	Pharmaceutical form: Suspension for injection in a pre-filled syringe, Route of administration: Intramuscular (IM)
BIOLOGICAL	Fluzone High-Dose Quadrivalent vaccine (0.7-mL dose), 2020-2021 formulation	Pharmaceutical form: Suspension for injection in a pre-filled syringe, Route of administration: IM

Timeline

• Start date: 2020-09-16
• Primary completion: 2020-12-18
• Completion: 2020-12-18
• First posted: 2020-09-16
• Last updated: 2025-09-12
• Results posted: 2021-07-13

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study