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Vaccine
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
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
Drug Has Already Been Approved
No Placebo-Only Group
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
- Flu Shot
- Healthy Subjects
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)
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
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
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Who is running the clinical trial?
Sanofi Pasteur, a Sanofi CompanyLead Sponsor
420 Previous Clinical Trials
6,110,224 Total Patients Enrolled
Clinical Sciences & OperationsStudy DirectorSanofi Pasteur, a Sanofi Company
876 Previous Clinical Trials
2,021,572 Total Patients Enrolled