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

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, Influenza Vaccines, 2019-2020 Formulations

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 6 Months – 83 Years
• Healthy volunteers: Accepted

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.

Detailed description

All participants received 1 intramuscular injection of the study vaccine associated with their assigned group at Visit 1. For participants 6 months to \< 9 years of age for whom 2 doses of influenza vaccine are recommended per Advisory Committee on Immunization Practices (ACIP) guidance, a second intramuscular injection of Fluzone Quadrivalent vaccine was administered at Visit 2 (28 days after Visit 1). Blood specimens were obtained from all participants prior to the first vaccination: * At Visit 1 (Day 0) and 28 days following the final vaccination (Visit 2, if no study vaccine was administered at Visit 2; or Visit 3, if a second dose of study vaccine was administered at Visit 2), for participants 6 months to \< 9 years of age (Group 1 and Group 2) * At Visit 1 and 21 (window, 21-28) days post-vaccination (Visit 2), for participants greater than or equal to (\>=) 65 years of age (Group 3) Serious Adverse Events (SAEs), suspected unexpected serious adverse reactions (SUSARs), or Adverse Event of Special Interests (AESIs) were collected from Visit 1 through Visit 2 for participants receiving 1 dose of study vaccine, and from Visit 1 through Visit 3 for participants receiving 2 doses of study vaccine. Study duration per participant was approximately 28 days for participants 6 months to less than (\<) 9 years of age, and 21 days for participants \>= 65 years of age.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Fluzone Quadrivalent vaccine, no preservative (0.5-mL), 2019-2020 formulation	Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
BIOLOGICAL	Fluzone High-Dose vaccine, 2019-2020 formulation	Pharmaceutical form: Suspension for injection Route of administration: Intramuscular

Timeline

• Start date: 2019-09-30
• Primary completion: 2019-12-10
• Completion: 2019-12-10
• First posted: 2019-09-30
• Last updated: 2025-09-12
• Results posted: 2020-12-17

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study