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

Phase 4

Completed

• Conditions: Healthy Volunteers; Influenza Immunization
• Interventions: Biological: Fluzone Quadrivalent vaccine, No Preservative (0.5-mL dose), 2020-2021 formulation; Biological: Fluzone High-Dose Quadrivalent vaccine (0.7-mL dose), 2020-2021 formulation

• Registration Number: NCT04551677
• Lead Sponsor: Sanofi Pasteur, a Sanofi Company

Brief 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.

Study Timeline

• Study First Submitted: 2020-08-27
• Study First Submitted QC: 2020-09-10
• Study Start: 2020-09-16
• Study First Posted: 2020-09-16
• Primary Completion: 2020-12-18
• Study Completion: 2020-12-18
• Results First Submitted: 2021-06-21
• Results First Submitted QC: 2021-06-21
• Results First Posted: 2021-07-13
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-26
• Last Update Posted: 2023-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1: Fluzone Quadrivalent Influenza Vaccine: 6 to <36 Months	Fluzone Quadrivalent vaccine, No Preservative (0.5-mL dose), 2020-2021 formulation	Participants aged 6 to \<36 months received a 0.5-milliliters (mL) dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 1. Participants for whom 2 doses of influenza vaccine were recommended per Advisory Committee on Immunization Practices (ACIP), a second dose was administered at Day 28.
Group 2: Fluzone Quadrivalent Influenza Vaccine: 3 to <9 Years	Fluzone Quadrivalent vaccine, No Preservative (0.5-mL dose), 2020-2021 formulation	Participants aged 3 to \<9 years received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 1. Participants for whom 2 doses of influenza vaccine were recommended per ACIP, a second dose was administered at Day 28.
Group 3: Fluzone High-Dose Quadrivalent Influenza Vaccine: >=65 Years	Fluzone High-Dose Quadrivalent vaccine (0.7-mL dose), 2020-2021 formulation	Participants aged \>=65 years received a 0.7-mL dose of Fluzone High-Dose Quadrivalent vaccine intramuscularly at Day 1.

Primary Outcome Measures

Name	Time	Method
Number of Participants Aged >=65 Years Who Provided Serum Samples for Analysis: Group 3	Visit 1 (Day 1; pre-vaccination) and 21 days post-vaccination (Visit 2)	Blood samples were collected from participants at first vaccination at Visit 1 (Day 1; pre-vaccination) and 21 days after vaccination (Visit 2). Collected blood samples were provided to CBER for further analysis by WHO, CDC, and FDA to support formulation recommendations for subsequent influenza vaccines.
Number of Participants Aged 6 Months to <9 Years Who Provided Serum Samples for Analysis: Groups 1 and 2	Visit 1 (Day 1; pre-vaccination) and 28 days post-final vaccination at Visit 2/Visit 3	Blood samples were collected from participants at first vaccination at Visit 1 (Day 1; pre-vaccination) and at Day 28 after final vaccination either at Visit 2 (Visit 1 + 28 days) for participants who received 1 dose of influenza vaccine; or at Visit 3 (Visit 2 + 28 days) for participants who received 2 doses of influenza vaccine as recommended by ACIP. Collected blood samples were provided to Center for Biologics Evaluation and Research (CBER) for further analysis by 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.

Trial Locations

Locations (2)

Investigational Site Number 8400002; 🇺🇸 Salt Lake City, Utah, United States

Investigational Site Number 8400001; 🇺🇸 Bardstown, Kentucky, United States