CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 90 enrolled
Drug / intervention
Fluzone Quadrivalent vaccine, No Preservative (0.5-mL dose), 2021-2022 formulation +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05050318
NCT05050318Phase 4Completed
CompareCT.gov

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, 2021-2022 Formulations

Sanofi Pasteur, a Sanofi Company·interventional·Posted Sep 20, 2021·Updated Sep 12, 2025

In Brief

A Phase 4 clinical trial evaluating Fluzone Quadrivalent vaccine, No Preservative (0.5-mL dose), 2021-2022 formulation and Fluzone High-Dose Quadrivalent vaccine (0.7-mL dose), 2021-2022 formulation for Influenza Immunization and Healthy Volunteers. Completed, enrolled 90 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza Immunization, Healthy Volunteers
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20222023202420252026
First PostedSep 20, 2021
Enrollment StartSep 8, 2021
Primary CompletionNov 10, 2021
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 4.8 years ago

Interventions

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

Suspension for injection in a pre-filled syringe Route of administration: Intramuscular (IM)

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

Suspension for injection in a pre-filled syringe Route of administration: Intramuscular (IM)