← Back to Search

Vaccine

Fluzone High-Dose Quadrivalent vaccine (0.7-mL dose), 2021-2022 formulation for Healthy Subjects

Phase 4

Waitlist Available

Research Sponsored by Sanofi Pasteur, a Sanofi Company

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up visit 1 (day 1; pre-vaccination) and 28 days post-final vaccination at visit 2 (for participants with 1 vaccination)/visit 3 (for participants with 2 vaccination)

Awards & highlights

No Placebo-Only Group

Drug Has Already Been Approved

Pivotal Trial

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.

Eligible Conditions

Healthy Subjects
Flu Shot

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ visit 1 (day 1; pre-vaccination) and 28 days post-final vaccination at visit 2 (for participants with 1 vaccination)/visit 3 (for participants with 2 vaccination)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~visit 1 (day 1; pre-vaccination) and 28 days post-final vaccination at visit 2 (for participants with 1 vaccination)/visit 3 (for participants with 2 vaccination)

This trial's timeline: 3 weeks for screening, Varies for treatment, and visit 1 (day 1; pre-vaccination) and 28 days post-final vaccination at visit 2 (for participants with 1 vaccination)/visit 3 (for participants with 2 vaccination) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants Aged 6 Months to <9 Years Who Provided Serum Samples for Analysis: Groups 1 and 2

Number of Participants Aged >=65 Years Who Provided Serum Samples for Analysis: Group 3

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Group 3: Fluzone High-Dose Quadrivalent Influenza Vaccine: >=65 YearsExperimental Treatment1 Intervention

Participants aged \>= 65 years received a 0.7-mL dose of Fluzone High-Dose Quadrivalent vaccine intramuscularly at Day 1.

Group II: Group 2: Fluzone Quadrivalent Influenza Vaccine: 3 to <9 YearsExperimental Treatment1 Intervention

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 III: Group 1: Fluzone Quadrivalent Influenza Vaccine: 6 to <36 MonthsExperimental Treatment1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fluzone Quadrivalent vaccine, No Preservative (0.5-mL dose), 2021-2022 formulation

2021

Completed Phase 4

~90

Fluzone High-Dose Quadrivalent vaccine (0.7-mL dose), 2021-2022 formulation

2021

Completed Phase 4

~90